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Active, not recruitingNCT04655976COSTAR LungUpdated Jul 1, 2026Results posted

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy

A Phase 2/3 interventional study of Cobolimab and Dostarlimab in Lung Cancer, Non-Small Cell, sponsored by GlaxoSmithKline. Active, not recruiting at 163 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by GlaxoSmithKline · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
758
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

02

Conditions studied

  • Lung Cancer, Non-Small Cell

Keywords

  • GSK4069889A
  • GSK4057190A
  • Cobolimab
  • Dostarlimab
  • Docetaxel
  • Chemotherapy
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 758 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma.
  • Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or an anti-PD-(L)1 antibody.
  • Participant has measurable disease.
  • Participant has documented radiographic disease progression on prior platinum based chemotherapy and on or after prior anti-PD-(L)1 therapy.
  • Participant agrees to submit an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease. If archival tissue is not available, the participant must undergo biopsy prior to study entry.
  • Participant has an ECOG performance status score of 0 or 1.
  • Participant has a life expectancy of at least 3 months.
  • Participant has adequate Baseline organ function.
  • Participant has recovered from any prior treatment related toxicities.
  • Participant agrees to use contraception.

Exclusion criteria

Exclusion Criteria:

  • Participant has been previously treated with an anti-PD-[L]1 or anti-programmed death-ligand 2 (anti-PD-[L]2) agent that resulted in permanent discontinuation due to an AE.
  • Participant has been previously treated with an anti-T cell immunoglobulin and mucin domain containing 3 (anti-TIM-3) or anti-cytotoxic T lymphocyte associated protein 4 (CTLA 4) agent or docetaxel.
  • Participant has a documented sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations.
  • Participant had radiological or clinical disease progression (i.e., worsening performance status, clinical symptoms, and laboratory data) \<=8 weeks after initiation of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan.
  • Participant has received radiation to the lung that is >30 gray (Gy) within 6 months prior to the first dose of study treatment.
  • Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.
  • Participant is ineligible if any of the following hepatic characteristics are present: a. Alanine aminotransferase (ALT) >2.5 times upper limit normal (ULN) b. ALT and/or aspartate aminotransferase (AST) >1.5 times ULN concomitant with alkaline phosphatase (ALP) >2.5 times ULN; c. Bilirubin >1 times ULN; d. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per the Investigator's assessment).
  • Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment.
  • Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment: a. Presence of hepatitis B surface antigen. b. Presence of hepatitis C antibody in the absence of a ribonucleic acid (RNA) test for hepatitis C virus. If a confirmatory RNA test is available, a positive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter into the study.
  • Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).
  • Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment.
  • Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis or paracentesis) is eligible.
  • Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management.
  • Participant has pre-existing peripheral neuropathy that is Grade >=2 by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria.
  • Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus and Coronavirus Disease 2019 (COVID-19) vaccines.
  • Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant does not have an archival biopsy), other than an aspirin dose \<=1.3 grams (g) per day, for a 5-day period (8-day) period for long-acting agents, such as piroxicam).
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
758 participants (actual)

Study arms

  • Experimental
    Participants receiving cobolimab+ dostarlimab+ docetaxel

    Biological: Cobolimab · Biological: Dostarlimab · Drug: Docetaxel

  • Experimental
    Participants receiving dostarlimab+ docetaxel

    Biological: Dostarlimab · Drug: Docetaxel

  • Active comparator
    Participants receiving docetaxel

    Drug: Docetaxel

Interventions

  • BiologicalCobolimab

    Cobolimab will be administered.

  • BiologicalDostarlimab

    Dostarlimab will be administered.

  • DrugDocetaxel

    Docetaxel will be administered.

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS) (Arm A Versus Arm C)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Time frame: Up to approximately 234 weeks

  2. Overall Survival (OS) (Arm B Versus Arm C)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Time frame: Up to approximately 234 weeks

Secondary outcomes

  1. Overall Survival (OS) (Arm A Versus Arm B)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Time frame: Up to approximately 234 weeks

  2. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR) as the best overall response based on Investigator assessment, evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 . PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm).

    Time frame: Up to approximately 234 weeks

  3. Progression Free Survival (PFS)

    PFS is defined as the length of time from randomization to the earliest date of assessment of disease progression based on RECIST v1.1 by Investigator assessment or death by any cause, whichever occurs first. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start. In addition, the sum has an absolute increase from nadir of 5 mm.)

    Time frame: Up to approximately 234 weeks

  4. Duration of Response (DOR)

    DOR is defined as the time from first documented response (CR/PR) until the time of first documentation of disease progression based on RECIST version 1.1 by Investigator assessment or death, whichever occurs first. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).

    Time frame: Up to approximately 234 weeks

  5. Time to Deterioration (TTD) in Lung Cancer

    TTD in lung cancer is defined as time from randomization to meaningful deterioration on a composite endpoint of dyspnea, chest pain, and cough, from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13 item Lung Cancer Module (EORTC-QLQ-LC13).

    Time frame: Up to approximately 234 weeks

  6. Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score

    The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These include five functional scales (physical functioning \[PF\], role functioning \[RF\], emotional functioning \[EF\] cognitive functioning \[CF\] and social functioning \[SF\]), three symptom scales (fatigue, nausea/vomiting \[N/V\] and pain), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (dyspnea, insomnia, appetite loss \[AL\], constipation, diarrhea and financial difficulties \[FD\]). Response options are 1 (Not at all) to 4 (Very much). Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Time frame: Baseline [Day(D) -1],D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)

  7. Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment

    The QLQ-LC13 questionnaire comprises 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea and site-specific pain which includes pain in chest, pain in arm or shoulder and pain in other parts), and treatment-related side effects (sore mouth \[SM\], dysphagia, peripheral neuropathy \[PN\] and alopecia). Response options are 1 (Not at all) to 4 (Very much). Scores were averaged and transformed to 0 to 100. Higher scores represent increasing symptom levels. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Time frame: Baseline (D -1),D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)

  8. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings

    ECGs were recorded after the participants were in a supine or semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes. ECG findings are summarized as clinically significant change from baseline worst case hierarchy: Yes \> No \> Not Applicable (NA).

    Time frame: Baseline (Day-1) up to Cycle 1 Day 1

  9. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Immune-mediate AEs (imAEs)

    A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

    Time frame: Up to 329 weeks

  10. Number of Participants With TEAEs Leading to Death and Treatment Discontinuation

    A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.

    Time frame: Up to 329 weeks

  11. Number of Participants Using Concomitant Medications

    Number of participants using concomitant medications will be presented.

    Time frame: Up to 329 weeks

  12. Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline

    Blood samples will be collected for the analysis of hematology parameters.

    Time frame: Up to 329 weeks

  13. Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline

    Blood samples will be collected for the analysis of Clinical Chemistry parameters.

    Time frame: Up to 329 weeks

  14. Number of Participants With Worst Case Thyroid Function Results by Maximum Grade Increase Post-Baseline Relative to Baseline

    Blood samples will be collected for the analysis of thyroid function

    Time frame: Up to 329 weeks

  15. Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline

    Urine samples will be collected to analyze urine specific gravity.

    Time frame: Up to 329 weeks

  16. Number of Participants With Worst Case Vital Signs Results Relative to Normal Range Post-Baseline Relative to Baseline

    Vital signs will be assessed

    Time frame: Up to 329 weeks

  17. Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Vital Signs

    Vital signs will be assessed and presented

    Time frame: Baseline (Day -1) and Up to 281 weeks

  18. Number of Participants With Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status

    Performance status will be assessed using the ECOG performance status scale.

    Time frame: Up to 329 weeks

  19. Number of Participants With Abnormal Physical Examinations

    Number of participants with abnormal physical examinations will be presented

    Time frame: Up to approximately 234 weeks

07

Results

Posted Jul 1, 2026

Participant flow

Participant flow — Overall Study
MilestoneCobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)
Started305301152
Intent-to-treat (itt) population305301152
Safety (saf) population302295144
Completed227236116
Not completed786536
Withdrew: Lost to follow-up321
Withdrew: Withdrawal by subject71613
Withdrew: Ongoing at the time of analysis684722

Outcome measures

PrimaryOverall Survival (OS) (Arm A Versus Arm C)

OS is defined as the time from the date of randomization to the date of death due to any cause.

Time frame:
Up to approximately 234 weeks
Reported as:
Median · Months
Overall Survival (OS) (Arm A Versus Arm C)
MonthsCobolimab + Dostarlimab + Docetaxel (Arm A)Docetaxel (Arm C)
Overall Survival (OS) (Arm A Versus Arm C)11.9 (10.6 to 14.2)11.3 (9.5 to 13.9)
Statistical analysis
  • Cobolimab + Dostarlimab + Docetaxel (Arm A) vs Docetaxel (Arm C) · One-sided stratified log rank · p = 0.079708 · Hazard ratio (hr): 0.85 · 95% CI 0.68 to 1.06HR was estimated using stratified cox proportional hazards model, and stratified based on following factors: prior lines of therapy (1 prior line vs 2 prior lines), PD-L1 status (TPS ≥50% vs TPS \<50%), and histology (squamous vs nonsquamous).
PrimaryOverall Survival (OS) (Arm B Versus Arm C)

OS is defined as the time from the date of randomization to the date of death due to any cause.

Time frame:
Up to approximately 234 weeks
Reported as:
Median · Months
Overall Survival (OS) (Arm B Versus Arm C)
MonthsDostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)
Overall Survival (OS) (Arm B Versus Arm C)11.8 (10.3 to 12.9)11.3 (9.5 to 13.9)
Statistical analysis
  • Dostarlimab + Docetaxel (Arm B) vs Docetaxel (Arm C) · One-sided stratified log rank · p = 0.369509 · Hazard ratio (hr): 0.96 · 95% CI 0.77 to 1.20HR was estimated using stratified cox proportional hazards model, and stratified based on following factors: prior lines of therapy (1 prior line vs 2 prior lines), PD-L1 status (TPS ≥50% vs TPS \<50%), and histology (squamous vs nonsquamous).
SecondaryOverall Survival (OS) (Arm A Versus Arm B)

OS is defined as the time from the date of randomization to the date of death due to any cause.

Time frame:
Up to approximately 234 weeks
Reported as:
Median · Months
Overall Survival (OS) (Arm A Versus Arm B)
MonthsCobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)
Overall Survival (OS) (Arm A Versus Arm B)11.9 (10.6 to 14.2)11.8 (10.3 to 12.9)
SecondaryOverall Response Rate (ORR)

ORR is defined as the percentage of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR) as the best overall response based on Investigator assessment, evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 . PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm).

Time frame:
Up to approximately 234 weeks
Reported as:
Number · Percentage of participants
Overall Response Rate (ORR)
Percentage of participantsCobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)
Overall Response Rate (ORR)18.7 (14.5 to 23.5)18.3 (14.1 to 23.1)14.5 (9.3 to 21.1)
SecondaryProgression Free Survival (PFS)

PFS is defined as the length of time from randomization to the earliest date of assessment of disease progression based on RECIST v1.1 by Investigator assessment or death by any cause, whichever occurs first. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start. In addition, the sum has an absolute increase from nadir of 5 mm.)

Time frame:
Up to approximately 234 weeks
Reported as:
Median · Months
Progression Free Survival (PFS)
MonthsCobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)
Progression Free Survival (PFS)4.4 (4.2 to 5.5)4.2 (4.0 to 5.4)4.1 (2.9 to 4.8)
SecondaryDuration of Response (DOR)

DOR is defined as the time from first documented response (CR/PR) until the time of first documentation of disease progression based on RECIST version 1.1 by Investigator assessment or death, whichever occurs first. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).

Time frame:
Up to approximately 234 weeks
Reported as:
Median · Months
Duration of Response (DOR)
MonthsCobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)
Duration of Response (DOR)8.3 (6.2 to 9.9)7.1 (6.3 to 9.4)8.8 (5.1 to 11.0)
SecondaryTime to Deterioration (TTD) in Lung Cancer

TTD in lung cancer is defined as time from randomization to meaningful deterioration on a composite endpoint of dyspnea, chest pain, and cough, from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13 item Lung Cancer Module (EORTC-QLQ-LC13).

Time frame:
Up to approximately 234 weeks
Reported as:
Median · Months
Time to Deterioration (TTD) in Lung Cancer
MonthsCobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)
Time to Deterioration (TTD) in Lung Cancer1.4 (1.2 to 1.5)1.4 (1.0 to 1.4)1.1 (0.8 to 1.4)
SecondaryChange From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score

The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These include five functional scales (physical functioning \[PF\], role functioning \[RF\], emotional functioning \[EF\] cognitive functioning \[CF\] and social functioning \[SF\]), three symptom scales (fatigue, nausea/vomiting \[N/V\] and pain), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (dyspnea, insomnia, appetite loss \[AL\], constipation, diarrhea and financial difficulties \[FD\]). Response options are 1 (Not at all) to 4 (Very much). Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Time frame:
Baseline [Day(D) -1],D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)
Reported as:
Mean · Scores on Scale
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Scores on ScaleCobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)
GHS/QoL, CFB to C2D11.0 ± 17.62-0.3 ± 20.06-0.3 ± 16.42
GHS/QoL, CFB to C3D10.3 ± 20.320.5 ± 19.75-2.8 ± 16.98
GHS/QoL, CFB to C4D1-0.4 ± 19.43-0.7 ± 21.06-4.7 ± 21.56
GHS/QoL, CFB to C5D1-1.5 ± 19.26-0.5 ± 20.530.2 ± 19.07
GHS/QoL, CFB to C6D1-1.3 ± 20.79-1.5 ± 20.31-8.5 ± 21.19
GHS/QoL, CFB to C9D1-1.2 ± 18.160.4 ± 19.97-10.4 ± 19.28
GHS/QoL, CFB to C12D1-4.1 ± 18.94-1.0 ± 20.97-9.8 ± 24.95
GHS/QoL, CFB to C15D1-0.9 ± 12.180 ± 18.84-15.0 ± 17.08
GHS/QoL, CFB to C18D1-2.4 ± 13.60-2.6 ± 17.27-8.3 ± 14.43
GHS/QoL, CFB to C22D1-1.8 ± 17.24-5.0 ± 15.150 ± NA
GHS/QoL, CFB to C26D1-1.3 ± 15.71-8.9 ± 16.51—
GHS/QoL, CFB to C30D11.0 ± 15.414.5 ± 18.200 ± NA
GHS/QoL, CFB to C34D1-2.3 ± 11.004.8 ± 16.570 ± NA
GHS/QoL, CFB to C38D1-9.0 ± 18.47-13.9 ± 38.25—
GHS/QoL, CFB to C42D11.0 ± 19.13-2.1 ± 10.490 ± NA
GHS/QoL, CFB to C46D10 ± 22.82-4.2 ± 5.890 ± NA
GHS/QoL, CFB to C50D1-1.7 ± 26.618.3 ± NA—
GHS/QoL, CFB to C54D11.4 ± 14.35-16.7 ± 11.79—
GHS/QoL, CFB to C58D112.5 ± 5.89-8.3 ± NA—
GHS/QoL, CFB to C62D1-4.2 ± 5.89-8.3 ± NA—
GHS/QoL, CFB to C66D1—8.3 ± NA—
GHS/QoL, CFB to EoT (~216 weeks)-10.7 ± 24.09-9.3 ± 20.16-11.6 ± 21.11
GHS/QoL, CFB to SFU D30 (~220 weeks)-9.4 ± 16.80-6.8 ± 15.07-7.5 ± 21.72
GHS/QoL, CFB to SFU D90 (~229 weeks)-7.7 ± 21.30-13.6 ± 21.45-2.6 ± 15.73
PF, CFB to C2D1-1.8 ± 14.58-0.9 ± 15.44-2.5 ± 15.23
PF, CFB to C3D1-0.1 ± 14.17-0.9 ± 15.74-3.2 ± 17.61
PF, CFB to C4D1-1.7 ± 16.61-3.9 ± 16.30-4.1 ± 17.48
PF, CFB to C5D1-5.3 ± 18.13-3.4 ± 18.83-5.0 ± 16.00
PF, CFB to C6D1-3.0 ± 19.62-3.8 ± 17.61-6.2 ± 15.89
PF, CFB to C9D1-2.4 ± 17.48-3.3 ± 18.67-9.0 ± 15.56
PF, CFB to C12D1-4.8 ± 17.10-2.1 ± 15.00-17.3 ± 19.87
PF, CFB to C15D1-2.8 ± 16.19-2.6 ± 20.35-16.7 ± 20.47
PF, CFB to C18D1-0.6 ± 13.94-3.1 ± 14.51-13.3 ± 18.05
PF, CFB to C22D1-4.2 ± 18.84-2.4 ± 17.88-16.7 ± 4.71
PF, CFB to C26D1-3.3 ± 25.07-0.8 ± 15.616.7 ± NA
PF, CFB to C30D1-0.5 ± 23.47-2.4 ± 16.04-6.7 ± NA
PF, CFB to C34D12.8 ± 16.071.0 ± 11.176.7 ± NA
PF, CFB to C38D13.6 ± 21.88-2.2 ± 8.07—
PF, CFB to C42D112.5 ± 16.500 ± 9.4313.3 ± NA
PF, CFB to C46D19.3 ± 14.613.3 ± 4.7113.3 ± NA
PF, CFB to C50D19.3 ± 17.380 ± NA—
PF, CFB to C54D1-1.1 ± 14.863.3 ± 4.71—
PF, CFB to C58D110.0 ± 23.5713.3 ± NA—
PF, CFB to C62D1-10.0 ± 4.7113.3 ± NA—
PF, CFB to C66D1—-6.7 ± NA—
PF, CFB to EOT (~216 weeks)-13.5 ± 21.17-14.4 ± 24.15-14.0 ± 24.89
PF, CFB to SFU D30 (~220 weeks)-9.1 ± 19.62-8.2 ± 17.87-6.7 ± 23.09
PF, CFB to SFU D90 (~229 weeks)-5.2 ± 24.42-15.9 ± 22.72-1.7 ± 10.75
RF, CFB to C2D1-0.3 ± 25.09-6.3 ± 22.77-4.6 ± 23.28
RF, CFB to C3D10 ± 26.98-4.0 ± 28.22-5.9 ± 28.58
RF, CFB to C4D1-4.8 ± 26.55-7.4 ± 25.40-7.4 ± 25.90
RF, CFB to C5D1-5.2 ± 28.81-7.4 ± 26.83-3.5 ± 23.72
RF, CFB to C6D1-2.9 ± 28.62-5.8 ± 24.98-6.7 ± 22.69
RF, CFB to C9D1-3.1 ± 29.22-7.1 ± 26.77-5.2 ± 21.41
RF, CFB to C12D1-2.2 ± 31.40-5.9 ± 23.52-11.8 ± 29.32
RF, CFB to C15D1-3.2 ± 25.64-7.3 ± 23.82-12.5 ± 24.80
RF, CFB to C18D1-0.4 ± 23.14-7.8 ± 19.93-4.2 ± 8.33
RF, CFB to C22D1-5.3 ± 28.73-6.8 ± 24.48-8.3 ± 11.79
RF, CFB to C26D1-1.0 ± 32.29-8.8 ± 19.650 ± NA
RF, CFB to C30D10.6 ± 28.86-15.5 ± 26.53-16.7 ± NA
RF, CFB to C34D14.4 ± 20.67-2.4 ± 17.820 ± NA
RF, CFB to C38D1-1.3 ± 30.02-2.8 ± 35.62—
RF, CFB to C42D18.3 ± 25.20-12.5 ± 25.000 ± NA
RF, CFB to C46D16.7 ± 19.00-16.7 ± 23.570 ± NA
RF, CFB to C50D113.3 ± 18.260 ± NA—
RF, CFB to C54D15.6 ± 20.180 ± 0—
RF, CFB to C58D10 ± 00 ± NA—
RF, CFB to C62D10 ± 23.570 ± NA—
RF, CFB to C66D1—-33.3 ± NA—
RF, CFB to EOT (~216 weeks)-16.3 ± 31.44-17.9 ± 28.81-14.7 ± 29.23
RF, CFB to SFU D30 (~220 weeks)-7.7 ± 34.80-13.7 ± 15.71-14.6 ± 25.21
RF, CFB to SFU D90(~229 weeks)-2.4 ± 37.47-18.8 ± 27.20-11.5 ± 24.88
EF, CFB to C2D13.7 ± 18.642.5 ± 17.74-0.9 ± 17.35
EF, CFB to C3D13.9 ± 17.821.5 ± 19.48-2.3 ± 18.11
EF, CFB to C4D13.6 ± 20.25-0.7 ± 19.13-0.3 ± 20.43
EF, CFB to C5D13.5 ± 20.33-0.3 ± 20.701.6 ± 19.06
EF, CFB to C6D13.6 ± 20.672.2 ± 21.961.9 ± 17.43
EF, CFB to C9D13.7 ± 20.46-1.6 ± 19.86-5.5 ± 20.32
EF, CFB to C12D10.1 ± 20.391.0 ± 16.53-3.4 ± 23.76
EF, CFB to C15D11.4 ± 22.032.1 ± 20.83-3.1 ± 19.38
EF, CFB to C18D11.7 ± 20.130.6 ± 16.66-6.3 ± 12.50
EF, CFB to C22D1-0.4 ± 19.720.8 ± 18.170 ± 0
EF, CFB to C26D11.2 ± 15.910.5 ± 18.970 ± NA
EF, CFB to C30D13.2 ± 18.57-1.8 ± 11.410 ± NA
EF, CFB to C34D15.7 ± 19.26-7.1 ± 20.650 ± NA
EF, CFB to C38D1-0.6 ± 16.12-2.8 ± 22.77—
EF, CFB to C42D16.3 ± 8.630 ± 11.790 ± NA
EF, CFB to C46D11.7 ± 10.8712.5 ± 17.68-33.3 ± NA
EF, CFB to C50D15.0 ± 19.180 ± NA—
EF, CFB to C54D115.3 ± 24.398.3 ± 23.57—
EF, CFB to C58D125.0 ± 23.570 ± NA—
EF, CFB to C62D137.5 ± 41.250 ± NA—
EF, CFB to C66D1—-16.7 ± NA—
EF, CFB to EOT (~216 weeks)-5.3 ± 22.15-7.4 ± 21.20-7.7 ± 26.44
EF, CFB to SFU D30(~220 weeks)-2.6 ± 17.54-3.4 ± 14.90-2.1 ± 21.74
EF, CFB to SFU D90(~229 weeks)-6.0 ± 22.03-8.3 ± 18.121.6 ± 16.45
CF, CFB to C2D10.3 ± 16.00-0.8 ± 18.02-2.1 ± 14.74
CF, CFB to C3D10 ± 14.23-1.4 ± 16.33-3.9 ± 18.03
CF, CFB to C4D10.1 ± 16.84-2.0 ± 18.050.2 ± 12.49
CF, CFB to C5D10.1 ± 19.32-3.1 ± 16.96-0.6 ± 17.81
CF, CFB to C6D11.6 ± 16.42-2.8 ± 18.35-0.6 ± 17.14
CF, CFB to C9D12.1 ± 16.94-5.9 ± 19.19-2.3 ± 20.28
CF, CFB to C12D10.9 ± 19.16-4.3 ± 19.39-2.0 ± 11.61
CF, CFB to C15D11.7 ± 13.50-4.3 ± 22.85-4.2 ± 11.79
CF, CFB to C18D11.6 ± 15.78-1.7 ± 19.74-4.2 ± 8.33
CF, CFB to C22D13.7 ± 16.03-4.5 ± 17.950 ± 0
CF, CFB to C26D12.0 ± 15.22-2.9 ± 19.750 ± NA
CF, CFB to C30D1-1.3 ± 17.59-9.5 ± 22.370 ± NA
CF, CFB to C34D11.8 ± 14.59-7.1 ± 16.270 ± NA
CF, CFB to C38D1-2.6 ± 20.24-2.8 ± 19.48—
CF, CFB to C42D12.1 ± 13.91-16.7 ± 13.610 ± NA
CF, CFB to C46D13.3 ± 13.940 ± 00 ± NA
CF, CFB to C50D1-6.7 ± 19.000 ± NA—
CF, CFB to C54D12.8 ± 12.550 ± 23.57—
CF, CFB to C58D116.7 ± 23.570 ± NA—
CF, CFB to C62D10 ± 00 ± NA—
CF, CFB to C66D1—-33.3 ± NA—
CF, CFB to EOT (~216 weeks)-6.2 ± 21.47-8.0 ± 20.26-7.7 ± 21.97
CF, CFB to SFU D30(~220 weeks)-2.6 ± 24.34-6.0 ± 17.31-2.8 ± 22.34
CF, CFB to SFU D90(~229 weeks)-6.0 ± 33.08-8.7 ± 22.961.0 ± 17.71
SF, CFB to C2D1-0.3 ± 23.310.4 ± 24.37-4.9 ± 22.16
SF, CFB to C3D1-0.4 ± 23.300.7 ± 24.87-6.7 ± 22.58
SF, CFB to C4D1-2.8 ± 23.01-3.7 ± 25.81-4.7 ± 23.17
SF, CFB to C5D1-3.6 ± 24.75-2.2 ± 25.39-4.7 ± 24.35
SF, CFB to C6D1-1.6 ± 24.23-0.4 ± 23.51-3.5 ± 20.96
SF, CFB to C9D11.5 ± 22.74-7.3 ± 28.22-10.9 ± 20.55
SF, CFB to C12D1-2.0 ± 24.35-3.4 ± 24.53-3.9 ± 20.01
SF, CFB to C15D10.9 ± 22.820.4 ± 18.13-10.4 ± 25.10
SF, CFB to C18D1-0.4 ± 18.72-3.9 ± 22.614.2 ± 8.33
SF, CFB to C22D1-2.0 ± 20.14-0.8 ± 21.508.3 ± 11.79
SF, CFB to C26D1-7.8 ± 21.41-8.8 ± 22.140 ± NA
SF, CFB to C30D1-0.6 ± 20.27-9.5 ± 21.400 ± NA
SF, CFB to C34D1-1.8 ± 19.95-7.1 ± 21.210 ± NA
SF, CFB to C38D1-1.3 ± 28.43-13.9 ± 19.48—
SF, CFB to C42D14.2 ± 23.15-4.2 ± 43.830 ± NA
SF, CFB to C46D16.7 ± 19.00-8.3 ± 11.790 ± NA
SF, CFB to C50D110.0 ± 22.36-16.7 ± NA—
SF, CFB to C54D12.8 ± 22.150 ± 23.57—
SF, CFB to C58D1-8.3 ± 11.7916.7 ± NA—
SF, CFB to C62D10 ± 016.7 ± NA—
SF, CFB to C66D1—-16.7 ± NA—
SF, CFB to EOT (~216 weeks)-10.8 ± 28.47-9.3 ± 28.76-12.2 ± 24.72
SF, CFB to SFU D30(~220 weeks)-7.3 ± 25.88-11.5 ± 23.31-6.9 ± 28.20
SF, CFB to SFU D90(~229 weeks)-15.5 ± 32.33-12.3 ± 30.66-2.1 ± 17.08
Fatigue, CFB to C2D12.8 ± 20.652.6 ± 21.564.8 ± 17.83
Fatigue, CFB to C3D11.4 ± 21.721.5 ± 22.846.3 ± 21.22
Fatigue, CFB to C4D12.5 ± 24.582.5 ± 23.216.9 ± 24.99
Fatigue, CFB to C5D13.8 ± 22.814.3 ± 24.723.5 ± 23.30
Fatigue, CFB to C6D12.7 ± 23.954.4 ± 24.784.7 ± 22.04
Fatigue, CFB to C9D13.6 ± 22.107.5 ± 23.099.6 ± 22.76
Fatigue, CFB to C12D16.2 ± 25.331.9 ± 20.1314.4 ± 28.26
Fatigue, CFB to C15D11.1 ± 21.900.6 ± 21.3212.5 ± 29.36
Fatigue, CFB to C18D1-0.3 ± 22.293.0 ± 19.782.8 ± 10.64
Fatigue, CFB to C22D13.8 ± 21.46-1.5 ± 14.2611.1 ± 15.71
Fatigue, CFB to C26D1-2.0 ± 22.632.0 ± 20.870 ± NA
Fatigue, CFB to C30D12.1 ± 23.52-0.8 ± 20.19-11.1 ± NA
Fatigue, CFB to C34D1-4.7 ± 17.101.6 ± 23.51-11.1 ± NA
Fatigue, CFB to C38D1-0.9 ± 28.130 ± 7.03—
Fatigue, CFB to C42D1-11.1 ± 15.7111.1 ± 20.29-11.1 ± NA
Fatigue, CFB to C46D1-8.9 ± 9.305.6 ± 23.570 ± NA
Fatigue, CFB to C50D1-13.3 ± 12.17-11.1 ± NA—
Fatigue, CFB to C54D1-11.1 ± 15.71-11.1 ± 31.43—
Fatigue, CFB to C58D10 ± 00 ± NA—
Fatigue, CFB to C62D1-5.6 ± 7.8611.1 ± NA—
Fatigue, CFB to C66D1—22.2 ± NA—
Fatigue, CFB to EOT (~216 weeks)13.9 ± 26.4512.4 ± 23.7512.6 ± 28.62
Fatigue, CFB to SFU D30(~220 weeks)11.5 ± 23.6510.0 ± 17.258.8 ± 23.85
Fatigue, CFB to SFUP D90(~229 weeks)6.3 ± 28.8115.5 ± 20.031.4 ± 21.03
N/V, CFB to C2D11.4 ± 14.611.2 ± 18.070.3 ± 15.33
N/V, CFB to C3D11.0 ± 15.491.5 ± 16.462.7 ± 15.13
N/V, CFB to C4D1-0.5 ± 13.000.9 ± 16.221.1 ± 14.16
N/V, CFB to C5D11.6 ± 15.581.9 ± 16.350.9 ± 13.88
N/V, CFB to C6D10 ± 13.041.0 ± 13.42-2.2 ± 10.96
N/V, CFB to C9D1-0.5 ± 13.633.3 ± 17.400.6 ± 10.43
N/V, CFB to C12D11.8 ± 14.900.3 ± 10.945.9 ± 11.70
N/V, CFB to C15D1-0.6 ± 13.60-0.9 ± 10.780 ± 0
N/V, CFB to C18D10.4 ± 15.210 ± 11.580 ± 0
N/V, CFB to C22D1-0.8 ± 16.65-0.8 ± 10.880 ± 0
N/V, CFB to C26D1-3.4 ± 17.302.0 ± 13.020 ± NA
N/V, CFB to C30D1-3.8 ± 18.442.4 ± 14.410 ± NA
N/V, CFB to C34D1-1.8 ± 13.490 ± 19.250 ± NA
N/V, CFB to C38D1-1.3 ± 15.90-2.8 ± 22.15—
N/V, CFB to C42D1-4.2 ± 21.364.2 ± 20.970 ± NA
N/V, CFB to C46D1-10.0 ± 22.360 ± 00 ± NA
N/V, CFB to C50D1-6.7 ± 25.280 ± NA—
N/V, CFB to C54D1-8.3 ± 20.410 ± 0—
N/V, CFB to C58D10 ± 23.570 ± NA—
N/V, CFB to C62D125.0 ± 35.360 ± NA—
N/V, CFB to C66D1—16.7 ± NA—
N/V, CFB to EOT (~216 weeks)4.8 ± 17.243.1 ± 19.795.0 ± 16.67
N/V, CFB to SFU D30(~220 weeks)4.3 ± 14.67-1.3 ± 12.320.7 ± 14.31
N/V, CFB to SFUP D90(~229 weeks)-2.4 ± 11.052.9 ± 19.24-1.0 ± 15.48
Pain, CFB to C2D1-3.5 ± 23.49-3.9 ± 25.663.0 ± 24.11
Pain, CFB to C3D1-6.4 ± 23.63-2.7 ± 27.453.5 ± 25.62
Pain, CFB to C4D1-2.9 ± 27.29-3.5 ± 26.491.8 ± 23.82
Pain, CFB to C5D1-1.0 ± 25.49-2.5 ± 25.27-1.5 ± 17.90
Pain, CFB to C6D1-3.5 ± 26.53-1.8 ± 24.23-0.3 ± 18.52
Pain, CFB to C9D10.7 ± 23.20-3.7 ± 27.746.3 ± 19.63
Pain, CFB to C12D15.3 ± 24.842.5 ± 26.9512.7 ± 29.77
Pain, CFB to C15D11.1 ± 19.960.9 ± 27.028.3 ± 25.20
Pain, CFB to C18D14.3 ± 18.583.9 ± 27.228.3 ± 9.62
Pain, CFB to C22D13.3 ± 17.17-4.5 ± 25.2916.7 ± 23.57
Pain, CFB to C26D10.5 ± 21.90-1.0 ± 19.070 ± NA
Pain, CFB to C30D15.8 ± 19.40-8.3 ± 25.9416.7 ± NA
Pain, CFB to C34D12.6 ± 17.800 ± 19.250 ± NA
Pain, CFB to C38D19.0 ± 17.50-5.6 ± 25.09—
Pain, CFB to C42D16.3 ± 17.680 ± 13.610 ± NA
Pain, CFB to C46D110.0 ± 19.00-8.3 ± 11.7916.7 ± NA
Pain, CFB to C50D113.3 ± 13.94-16.7 ± NA—
Pain, CFB to C54D15.6 ± 13.61-8.3 ± 11.79—
Pain, CFB to C58D116.7 ± 0-33.3 ± NA—
Pain, CFB to C62D116.7 ± 23.57-16.7 ± NA—
Pain, CFB to C66D1—0 ± NA—
Pain, CFB to EOT (~216 weeks)9.4 ± 30.3710.9 ± 29.9810.4 ± 30.96
Pain, CFB to SFU D30(~220 weeks)9.8 ± 23.176.0 ± 20.416.3 ± 29.00
Pain, CFB to SFU D90(~229 weeks)4.8 ± 31.645.1 ± 32.352.1 ± 20.07
Dyspnea, CFB to C2D1-1.7 ± 23.96-1.1 ± 26.641.9 ± 24.17
Dyspnea, CFB to C3D1-3.0 ± 26.78-0.5 ± 27.253.2 ± 26.80
Dyspnea, CFB to C4D10.9 ± 27.960.8 ± 25.996.3 ± 27.96
Dyspnea, CFB to C5D12.0 ± 30.021.3 ± 26.812.9 ± 25.42
Dyspnea, CFB to C6D1-0.2 ± 27.632.1 ± 23.793.8 ± 26.94
Dyspnea, CFB to C9D11.3 ± 29.034.3 ± 26.1213.8 ± 28.89
Dyspnea, CFB to C12D10.9 ± 27.93-4.5 ± 25.1121.6 ± 28.73
Dyspnea, CFB to C15D1-1.7 ± 20.16-6.1 ± 24.3325.0 ± 38.83
Dyspnea, CFB to C18D11.6 ± 24.07-7.8 ± 22.638.3 ± 16.67
Dyspnea, CFB to C22D10.8 ± 25.26-3.0 ± 22.7916.7 ± 23.57
Dyspnea, CFB to C26D10 ± 34.3610.4 ± 26.440 ± NA
Dyspnea, CFB to C30D10 ± 28.282.4 ± 20.5233.3 ± NA
Dyspnea, CFB to C34D1-5.3 ± 33.820 ± 27.220 ± NA
Dyspnea, CFB to C38D1-10.3 ± 25.045.6 ± 25.09—
Dyspnea, CFB to C42D1-4.2 ± 11.7916.7 ± 33.330 ± NA
Dyspnea, CFB to C46D16.7 ± 14.9133.3 ± 00 ± NA
Dyspnea, CFB to C50D10 ± 23.570 ± NA—
Dyspnea, CFB to C54D1-5.6 ± 25.090 ± 0—
Dyspnea, CFB to C58D1-16.7 ± 23.570 ± NA—
Dyspnea, CFB to C62D1-33.3 ± 00 ± NA—
Dyspnea, CFB to C66D1—33.3 ± NA—
Dyspnea, CFB to EOT (~216 weeks)11.4 ± 30.7411.6 ± 32.8812.1 ± 30.74
Dyspnea, CFB to SFU D30(~220 weeks)9.4 ± 33.298.5 ± 36.456.9 ± 29.45
Dyspnea, CFB to SFU D90(~229 weeks)-9.5 ± 27.5133.3 ± 37.612.1 ± 33.26
Insomnia, CFB to C2D1-3.3 ± 25.83-2.7 ± 30.24-1.0 ± 30.82
Insomnia, CFB to C3D1-7.9 ± 25.330.2 ± 31.760.4 ± 30.72
Insomnia, CFB to C4D1-6.6 ± 26.51-0.6 ± 30.290.5 ± 32.40
Insomnia, CFB to C5D1-4.5 ± 28.810.3 ± 32.412.3 ± 30.12
Insomnia, CFB to C6D1-4.3 ± 28.03-1.8 ± 30.16-1.3 ± 33.63
Insomnia, CFB to C9D1-5.3 ± 25.701.2 ± 33.11-1.1 ± 20.86
Insomnia, CFB to C12D1-0.9 ± 26.831.1 ± 33.883.9 ± 26.04
Insomnia, CFB to C15D1-3.4 ± 23.93-5.1 ± 28.148.3 ± 23.57
Insomnia, CFB to C18D12.3 ± 23.454.4 ± 31.248.3 ± 16.67
Insomnia, CFB to C22D11.6 ± 21.02-4.5 ± 27.780 ± 0
Insomnia, CFB to C26D1-2.9 ± 23.74-3.9 ± 30.920 ± NA
Insomnia, CFB to C30D1-3.8 ± 17.202.4 ± 33.2433.3 ± NA
Insomnia, CFB to C34D1-3.5 ± 15.2928.6 ± 35.630 ± NA
Insomnia, CFB to C38D1-2.6 ± 9.2511.1 ± 34.43—
Insomnia, CFB to C42D14.2 ± 21.3633.3 ± 27.220 ± NA
Insomnia, CFB to C46D16.7 ± 36.5150.0 ± 23.570 ± NA
Insomnia, CFB to C50D16.7 ± 14.9133.3 ± NA—
Insomnia, CFB to C54D10 ± 21.0833.3 ± 47.14—
Insomnia, CFB to C58D1-16.7 ± 23.5733.3 ± NA—
Insomnia, CFB to C62D10 ± 00 ± NA—
Insomnia, CFB to C66D1—33.3 ± NA—
Insomnia, CFB to EOT (~216 weeks)5.6 ± 31.446.5 ± 32.441.0 ± 35.76
Insomnia, CFB to SFU D30(~220 weeks)-5.3 ± 31.512.6 ± 29.001.4 ± 30.26
Insomnia, CFB to SFU D90(~229 weeks)4.8 ± 31.641.4 ± 34.05-14.6 ± 34.36
AL, CFB to C2D11.9 ± 28.681.9 ± 28.235.4 ± 25.79
AL, CFB to C3D1-2.1 ± 28.423.1 ± 31.035.4 ± 27.64
AL, CFB to C4D1-0.7 ± 26.84-0.2 ± 27.683.2 ± 32.25
AL, CFB to C5D13.7 ± 29.02-0.8 ± 32.932.9 ± 27.66
AL, CFB to C6D11.8 ± 27.90-1.8 ± 30.16-1.9 ± 25.92
AL, CFB to C9D1-3.0 ± 26.423.5 ± 33.343.4 ± 22.44
AL, CFB to C12D16.2 ± 28.843.4 ± 33.165.9 ± 21.20
AL, CFB to C15D11.7 ± 29.573.4 ± 25.130 ± 17.82
AL, CFB to C18D1-3.9 ± 31.880 ± 29.030 ± 27.22
AL, CFB to C22D16.5 ± 29.08-3.0 ± 25.010 ± 0
AL, CFB to C26D1-2.9 ± 34.202.0 ± 24.920 ± 0
AL, CFB to C30D1-3.8 ± 33.10-2.4 ± 24.33-33.3 ± NA
AL, CFB to C34D10 ± 31.43-9.5 ± 37.09-33.3 ± NA
AL, CFB to C38D1-2.6 ± 34.5911.1 ± 17.21—
AL, CFB to C42D10 ± 30.868.3 ± 16.67-33.3 ± NA
AL, CFB to C46D1-6.7 ± 36.510 ± 0-33.3 ± NA
AL, CFB to C50D10 ± 40.820 ± NA—
AL, CFB to C54D1-16.7 ± 40.820 ± 0—
AL, CFB to C58D1-33.3 ± 47.140 ± NA—
AL, CFB to C62D10 ± 00 ± NA—
AL, CFB to C66D1—0 ± NA—
AL, CFB to EOT (~216 weeks)12.1 ± 31.908.0 ± 34.789.0 ± 30.47
AL, CFB to SFU D30(~220 weeks)5.3 ± 32.443.4 ± 23.930 ± 24.08
AL, CFB to SFU D90(~229 weeks)-7.1 ± 41.7110.1 ± 29.19-4.2 ± 23.96
Constipation, CFB to C2D1-0.9 ± 21.87-2.4 ± 25.34-1.3 ± 25.29
Constipation, CFB to C3D1-0.3 ± 20.92-0.4 ± 26.69-1.4 ± 25.83
Constipation, CFB to C4D1-0.7 ± 21.79-5.0 ± 27.441.8 ± 29.14
Constipation, CFB to C5D10.8 ± 21.58-2.8 ± 25.010 ± 30.86
Constipation, CFB to C6D1-2.0 ± 24.66-3.5 ± 26.11-4.5 ± 25.59
Constipation, CFB to C9D10.7 ± 21.07-3.5 ± 30.872.3 ± 25.09
Constipation, CFB to C12D10.4 ± 21.57-4.5 ± 28.679.8 ± 15.66
Constipation, CFB to C15D1-0.6 ± 20.22-10.3 ± 28.774.2 ± 11.79
Constipation, CFB to C18D1-1.6 ± 22.95-13.3 ± 27.128.3 ± 16.67
Constipation, CFB to C22D1-3.3 ± 22.12-7.6 ± 22.840 ± 0
Constipation, CFB to C26D11.0 ± 17.38-7.8 ± 27.710 ± NA
Constipation, CFB to C30D1-1.3 ± 19.96-4.8 ± 31.640 ± NA
Constipation, CFB to C34D1-1.8 ± 17.480 ± 27.220 ± NA
Constipation, CFB to C38D1-7.7 ± 14.62-5.6 ± 13.61—
Constipation, CFB to C42D10 ± 17.828.3 ± 31.910 ± NA
Constipation, CFB to C46D1-6.7 ± 14.9133.3 ± 00 ± NA
Constipation, CFB to C50D1-6.7 ± 14.910 ± NA—
Constipation, CFB to C54D1-5.6 ± 13.610 ± NA—
Constipation, CFB to C58D116.7 ± 23.570 ± NA—
Constipation, CFB to C62D10 ± 00 ± NA—
Constipation, CFB to C66D1—33.3 ± NA—
Constipation, CFB to EOT (~216 weeks)6.1 ± 25.09-4.3 ± 30.093.0 ± 27.67
Constipation, CFB to SFU D30(~220 weeks)1.7 ± 28.56-8.5 ± 28.32-6.9 ± 27.77
Constipation, CFB to SFU D90(~229 weeks)11.9 ± 28.06-8.7 ± 27.00-8.3 ± 22.77
Diarrhea, CFB to C2D12.1 ± 18.053.5 ± 21.294.1 ± 18.31
Diarrhea, CFB to C3D12.5 ± 17.184.3 ± 17.875.0 ± 19.53
Diarrhea, CFB to C4D12.5 ± 17.063.7 ± 18.263.2 ± 14.77
Diarrhea, CFB to C5D13.9 ± 17.082.1 ± 18.591.8 ± 17.16
Diarrhea, CFB to C6D13.6 ± 16.562.9 ± 18.131.9 ± 15.36
Diarrhea, CFB to C9D13.6 ± 18.802.4 ± 17.668.0 ± 21.19
Diarrhea, CFB to C12D11.8 ± 18.903.4 ± 18.412.0 ± 14.29
Diarrhea, CFB to C15D1-1.7 ± 14.54-2.6 ± 11.810 ± 0
Diarrhea, CFB to C18D13.9 ± 14.92-6.7 ± 16.148.3 ± 16.67
Diarrhea, CFB to C22D1-0.8 ± 13.92-6.1 ± 16.700 ± 0
Diarrhea, CFB to C26D11.0 ± 15.32-5.9 ± 17.620 ± NA
Diarrhea, CFB to C30D1-2.6 ± 13.07-2.4 ± 15.820 ± NA
Diarrhea, CFB to C34D11.8 ± 17.48-4.8 ± 12.600 ± NA
Diarrhea, CFB to C38D1-2.6 ± 16.450 ± 21.08—
Diarrhea, CFB to C42D10 ± 08.3 ± 16.670 ± NA
Diarrhea, CFB to C46D10 ± 00 ± 00 ± NA
Diarrhea, CFB to C50D10 ± 00 ± NA—
Diarrhea, CFB to C54D15.6 ± 13.610 ± 0—
Diarrhea, CFB to C58D10 ± 00 ± NA—
Diarrhea, CFB to C62D116.7 ± 23.570 ± NA—
Diarrhea, CFB to C66D1—0 ± NA—
Diarrhea, CFB to EOT (~216 weeks)4.8 ± 22.202.9 ± 20.724.5 ± 18.25
Diarrhea, CFB to SFU D30(~220 weeks)4.3 ± 21.877.7 ± 16.151.4 ± 15.48
Diarrhea, CFB to SFU D90(~229 weeks)-2.4 ± 20.522.9 ± 26.43-2.1 ± 8.33
FD, CFB to C2D1-2.5 ± 23.44-1.7 ± 22.172.5 ± 20.51
FD, CFB to C3D10.3 ± 24.31-1.6 ± 22.662.9 ± 20.17
FD, CFB to C4D1-1.4 ± 22.680.2 ± 22.822.7 ± 24.52
FD, CFB to C5D10.8 ± 23.04-0.5 ± 24.48-1.2 ± 21.99
FD, CFB to C6D11.4 ± 21.611.5 ± 20.11-1.9 ± 16.72
FD, CFB to C9D11.3 ± 22.075.1 ± 28.41-1.1 ± 18.86
FD, CFB to C12D1-0.4 ± 24.190 ± 21.63-2.0 ± 14.29
FD, CFB to C15D10 ± 24.982.6 ± 23.430 ± 0
FD, CFB to C18D1-0.8 ± 17.041.1 ± 22.290 ± 0
FD, CFB to C22D15.7 ± 26.773.0 ± 17.550 ± 0
FD, CFB to C26D11.0 ± 23.902.0 ± 18.520 ± NA
FD, CFB to C30D13.8 ± 17.204.8 ± 25.680 ± NA
FD, CFB to C34D1-1.8 ± 17.489.5 ± 31.710 ± NA
FD, CFB to C38D10 ± 23.5711.1 ± 34.43—
FD, CFB to C42D14.2 ± 45.218.3 ± 31.910 ± NA
FD, CFB to C46D10 ± 40.82-16.7 ± 23.570 ± NA
FD, CFB to C50D1-6.7 ± 36.510 ± NA—
FD, CFB to C54D111.1 ± 34.43-16.7 ± 23.57—
FD, CFB to C58D10 ± 0-33.3 ± 0—
FD, CFB to C62D10 ± 0-33.3 ± NA—
FD, CFB to C66D1—0 ± NA—
FD, CFB to EOT (~216 weeks)5.8 ± 27.677.1 ± 26.645.5 ± 26.97
FD, CFB to SFU D30(~220 weeks)1.7 ± 28.565.1 ± 23.62-4.2 ± 26.58
FD, CFB to SFU D90(~229 weeks)0 ± 22.652.9 ± 26.438.3 ± 25.82
SecondaryChange From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment

The QLQ-LC13 questionnaire comprises 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea and site-specific pain which includes pain in chest, pain in arm or shoulder and pain in other parts), and treatment-related side effects (sore mouth \[SM\], dysphagia, peripheral neuropathy \[PN\] and alopecia). Response options are 1 (Not at all) to 4 (Very much). Scores were averaged and transformed to 0 to 100. Higher scores represent increasing symptom levels. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Time frame:
Baseline (D -1),D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)
Reported as:
Mean · Scores on Scale
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Scores on ScaleCobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)
Dyspnea, CFB to C2D11.9 ± 17.410.8 ± 17.574.2 ± 17.80
Dyspnea, CFB to C3D13.5 ± 20.812.9 ± 18.542.3 ± 15.79
Dyspnea, CFB to C4D13.1 ± 19.803.4 ± 18.115.8 ± 19.05
Dyspnea, CFB to C5D15.8 ± 21.535.0 ± 17.796.7 ± 22.99
Dyspnea, CFB to C6D15.4 ± 21.224.6 ± 17.634.3 ± 16.01
Dyspnea, CFB to C9D16.2 ± 22.906.7 ± 17.009.1 ± 22.03
Dyspnea, CFB to C12D16.1 ± 21.313.8 ± 17.4817.6 ± 24.55
Dyspnea, CFB to C15D17.3 ± 17.92-2.0 ± 17.0823.6 ± 34.34
Dyspnea, CFB to C18D15.0 ± 14.00-1.5 ± 16.1822.2 ± 18.14
Dyspnea, CFB to C22D16.5 ± 17.21-5.1 ± 20.2111.1 ± 15.71
Dyspnea, CFB to C26D18.7 ± 15.65-2.0 ± 21.240 ± NA
Dyspnea, CFB to C30D16.7 ± 15.71-0.8 ± 16.570 ± NA
Dyspnea, CFB to C34D18.3 ± 20.354.8 ± 14.140 ± NA
Dyspnea, CFB to C38D16.0 ± 20.093.7 ± 11.48—
Dyspnea, CFB to C42D12.8 ± 11.508.3 ± 18.9822.2 ± NA
Dyspnea, CFB to C46D10 ± 15.71-5.6 ± 7.8622.2 ± NA
Dyspnea, CFB to C50D13.7 ± 5.74-11.1 ± NA—
Dyspnea, CFB to C54D1-1.9 ± 20.39-5.6 ± 7.86—
Dyspnea, CFB to C58D17.4 ± 6.42-11.1 ± NA—
Dyspnea, CFB to C62D1-5.6 ± 7.860 ± NA—
Dyspnea, CFB to C66D1—0 ± NA—
Dyspnea, CFB to EOT (~216 weeks)14.3 ± 24.1314.3 ± 26.589.7 ± 22.35
Dyspnea, CFB to SFU D30 (~220 weeks)16.5 ± 21.9513.9 ± 23.978.2 ± 23.98
Dyspnea, CFB to SFU D90 (~229 weeks)9.5 ± 17.3525.1 ± 21.254.2 ± 26.87
Cough, CFB to C2D1-2.2 ± 23.06-1.7 ± 24.73-0.3 ± 23.57
Cough, CFB to C3D1-2.2 ± 24.66-2.1 ± 26.13-3.6 ± 25.88
Cough, CFB to C4D10.6 ± 26.76-0.9 ± 29.66-4.0 ± 26.92
Cough, CFB to C5D1-2.5 ± 26.87-2.1 ± 27.67-4.3 ± 26.73
Cough, CFB to C6D10.2 ± 27.76-4.8 ± 25.36-4.0 ± 29.84
Cough, CFB to C9D1-0.7 ± 23.30-2.1 ± 29.97-1.1 ± 28.84
Cough, CFB to C12D1-2.3 ± 25.40-7.5 ± 32.4715.7 ± 37.49
Cough, CFB to C15D10.6 ± 17.56-6.0 ± 28.4816.7 ± 30.86
Cough, CFB to C18D10.8 ± 21.99-13.3 ± 29.81-8.3 ± 16.67
Cough, CFB to C22D10.8 ± 26.34-16.7 ± 19.920 ± 0
Cough, CFB to C26D1-1.0 ± 26.07-7.8 ± 25.080 ± NA
Cough, CFB to C30D1-6.7 ± 27.22-9.5 ± 20.37-33.3 ± NA
Cough, CFB to C34D1-1.7 ± 20.16-4.8 ± 23.00-33.3 ± NA
Cough, CFB to C38D1-7.7 ± 27.74-5.6 ± 32.77—
Cough, CFB to C42D1-20.8 ± 24.8016.7 ± 33.330 ± NA
Cough, CFB to C46D1-27.8 ± 38.97-16.7 ± 23.57-33.3 ± NA
Cough, CFB to C50D1-16.7 ± 45.95-33.3 ± NA—
Cough, CFB to C54D1-33.3 ± 36.510 ± 0—
Cough, CFB to C58D1-22.2 ± 19.25-33.3 ± NA—
Cough, CFB to C62D1-16.7 ± 23.57-33.3 ± NA—
Cough, CFB to C66D1—0 ± NA—
Cough, CFB to EOT(~216 weeks)2.4 ± 28.552.8 ± 32.182.1 ± 28.79
Cough, CFB to SFU D30 (~220 weeks)2.9 ± 33.703.3 ± 32.73-1.4 ± 23.52
Cough, CFB to SFU D90(~229 weeks)-4.8 ± 22.107.2 ± 31.710 ± 21.08
Hemoptysis, CFB to C2D1-0.7 ± 10.93-2.5 ± 11.080.3 ± 10.10
Hemoptysis, CFB to C3D1-1.3 ± 10.64-1.3 ± 12.080.4 ± 14.16
Hemoptysis, CFB to C4D1-1.4 ± 13.82-1.9 ± 10.870 ± 12.97
Hemoptysis, CFB to C5D1-2.0 ± 13.60-1.3 ± 11.380 ± 12.95
Hemoptysis, CFB to C6D1-1.9 ± 15.00-1.8 ± 8.81-0.7 ± 10.63
Hemoptysis, CFB to C9D1-2.6 ± 13.43-0.8 ± 10.510 ± 8.91
Hemoptysis, CFB to C12D1-1.4 ± 16.37-1.7 ± 11.552.0 ± 8.08
Hemoptysis, CFB to C15D1-0.6 ± 10.121.7 ± 10.680 ± 17.82
Hemoptysis, CFB to C18D10 ± 7.55-2.2 ± 8.460 ± 0
Hemoptysis, CFB to C22D13.3 ± 14.54-3.0 ± 9.810 ± 0
Hemoptysis, CFB to C26D1-2.1 ± 8.20-2.0 ± 14.290 ± NA
Hemoptysis, CFB to C30D1-1.3 ± 6.67-4.8 ± 12.100 ± NA
Hemoptysis, CFB to C34D10 ± 0-4.8 ± 12.600 ± NA
Hemoptysis, CFB to C38D1-2.6 ± 9.25-5.6 ± 13.61—
Hemoptysis, CFB to C42D10 ± 0-8.3 ± 16.670 ± NA
Hemoptysis, CFB to C46D1-5.6 ± 13.61-16.7 ± 23.570 ± NA
Hemoptysis, CFB to C50D1-5.6 ± 13.610 ± NA—
Hemoptysis, CFB to C54D1-5.6 ± 13.61-16.7 ± 23.57—
Hemoptysis, CFB to C58D10 ± 00 ± NA—
Hemoptysis, CFB to C62D10 ± 00 ± NA—
Haemoptysis, CFB to C66D1—0 ± NA—
Hemoptysis, CFB to EOT(~216 weeks)2.7 ± 12.761.3 ± 15.081.0 ± 11.74
Hemoptysis, CFB to SFU D30-1.0 ± 12.752.5 ± 8.89-1.4 ± 6.95
Hemoptysis, CFB to SFU D90(~229 weeks)0 ± 13.072.9 ± 13.902.1 ± 8.33
SM, CFB to C2D15.6 ± 21.375.2 ± 24.183.0 ± 19.69
SM, CFB to C3D17.7 ± 22.067.5 ± 26.123.2 ± 19.78
SM, CFB to C4D15.3 ± 18.976.0 ± 21.252.5 ± 21.17
SM, CFB to C5D16.0 ± 19.406.3 ± 24.663.1 ± 20.75
SM, CFB to C6D15.3 ± 18.122.7 ± 17.492.7 ± 21.12
SM, CFB to C9D14.0 ± 18.482.5 ± 18.846.9 ± 22.50
SM, CFB to C12D10.5 ± 13.212.3 ± 22.392.0 ± 18.52
SM, CFB to C15D12.4 ± 15.52-1.7 ± 18.6512.5 ± 35.36
SM, CFB to C18D1-0.8 ± 9.21-1.1 ± 16.340 ± 0
SM, CFB to C22D10 ± 7.453.0 ± 14.210 ± 0
SM, CFB to C26D12.1 ± 14.512.0 ± 14.290 ± 0
SM, CFB to C30D12.7 ± 13.332.4 ± 8.910 ± NA
SM, CFB to C34D11.7 ± 13.134.8 ± 12.600 ± NA
SM, CFB to C38D12.6 ± 9.250 ± 0—
SM, CFB to C42D10 ± 016.7 ± 19.250 ± NA
SM, CFB to C46D15.6 ± 13.6116.7 ± 23.570 ± NA
SM, CFB to C50D10 ± 00 ± NA—
SM, CFB to C54D10 ± 00 ± 0—
SM, CFB to C58D10 ± 00 ± NA—
SM, CFB to C62D10 ± 00 ± NA—
SM, CFB to C66D1—33.3 ± NA—
SM, CFB to EOT(~216 weeks)3.3 ± 15.478.3 ± 25.181.0 ± 17.65
SM, CFB to SFU D30 (~220 weeks)2.9 ± 21.951.7 ± 15.001.4 ± 15.82
SM, CFB to SFU D90 (~229 weeks)2.4 ± 8.911.4 ± 21.278.3 ± 19.25
Dysphagia, CFB to C2D11.0 ± 17.622.2 ± 15.342.0 ± 18.94
Dysphagia, CFB to C3D10.7 ± 18.334.0 ± 16.175.6 ± 23.04
Dysphagia, CFB to C4D10 ± 17.011.9 ± 16.174.5 ± 20.84
Dysphagia, CFB to C5D12.0 ± 16.142.1 ± 19.953.1 ± 16.21
Dysphagia, CFB to C6D10.7 ± 15.840.3 ± 14.562.7 ± 17.61
Dysphagia, CFB to C9D11.5 ± 16.411.6 ± 13.851.1 ± 14.04
Dysphagia, CFB to C12D1-2.8 ± 13.515.2 ± 21.453.9 ± 11.07
Dysphagia, CFB to C15D1-1.2 ± 12.77-0.9 ± 5.344.2 ± 11.79
Dysphagia, CFB to C18D10.8 ± 11.910 ± 8.750 ± 0
Dysphagia, CFB to C22D1-1.6 ± 12.80-3.0 ± 9.810 ± 0
Dysphagia, CFB to C26D1-1.0 ± 13.350 ± 11.790 ± NA
Dysphagia, CFB to C30D1-1.3 ± 11.712.4 ± 8.910 ± NA
Dysphagia, CFB to C34D1-1.7 ± 7.4514.3 ± 26.230 ± NA
Dysphagia, CFB to C38D1-2.6 ± 9.250 ± 0—
Dysphagia, CFB to C42D14.2 ± 11.790 ± 00 ± NA
Dysphagia, CFB to C46D10 ± 00 ± 00 ± NA
Dysphagia, CFB to C50D10 ± 00 ± NA—
Dysphagia, CFB to C54D1-5.6 ± 13.610 ± 0—
Dysphagia, CFB to C58D1-11.1 ± 19.250 ± NA—
Dysphagia, CFB to C62D1-16.7 ± 23.570 ± NA—
Dysphagia, CFB to C66D1—33.3 ± NA—
Dysphagia, CFB to EOT(~216 weeks)5.4 ± 19.798.3 ± 20.335.6 ± 18.23
Dysphagia, CFB to SFU D30 (~220 weeks)1.9 ± 22.780.8 ± 14.102.9 ± 24.44
Dysphagia, CFB to SFU D90 (~229 weeks)7.1 ± 14.198.7 ± 20.644.2 ± 11.39
PN, CFB to C2D12.7 ± 19.38-1.0 ± 22.142.7 ± 21.12
PN, CFB to C3D13.4 ± 24.461.0 ± 25.014.8 ± 22.64
PN, CFB to C4D15.3 ± 23.943.4 ± 26.018.5 ± 22.73
PN, CFB to C5D110.6 ± 29.119.1 ± 27.971.2 ± 20.44
PN, CFB to C6D110.0 ± 24.716.9 ± 29.176.0 ± 25.81
PN, CFB to C9D19.3 ± 27.8312.8 ± 29.619.5 ± 23.76
PN, CFB to C12D111.9 ± 26.645.7 ± 21.759.8 ± 15.66
PN, CFB to C15D17.9 ± 27.197.7 ± 30.074.2 ± 21.36
PN, CFB to C18D114.2 ± 30.095.6 ± 30.4316.7 ± 19.25
PN, CFB to C22D16.5 ± 23.839.1 ± 27.5716.7 ± 23.57
PN, CFB to C26D11.0 ± 29.923.9 ± 30.920 ± NA
PN, CFB to C30D110.7 ± 24.940 ± 18.490 ± NA
PN, CFB to C34D1-5.0 ± 27.0914.3 ± 17.820 ± NA
PN, CFB to C38D10 ± 33.330 ± 21.08—
PN, CFB to C42D1-4.2 ± 21.3616.7 ± 19.2533.3 ± NA
PN, CFB to C46D1-5.6 ± 25.090 ± 00 ± NA
PN, CFB to C50D15.6 ± 25.090 ± NA—
PN, CFB to C54D1-11.1 ± 40.370 ± 0—
PN, CFB to C58D1-22.2 ± 50.920 ± NA—
PN, CFB to C62D1-50.0 ± 23.570 ± NA—
PN, CFB to C66D1—0 ± NA—
PN, CFB to EOT(~216 weeks)11.4 ± 27.5211.1 ± 28.448.3 ± 28.48
PN, CFB to SFU D30 (~220 weeks)6.7 ± 25.3111.7 ± 24.5213.0 ± 24.08
PN, CFB to SFU D90 (~229 weeks)14.3 ± 38.6010.1 ± 25.496.3 ± 27.81
Alopecia, CFB to C2D141.3 ± 40.5342.5 ± 43.9542.4 ± 42.54
Alopecia, CFB to C3D141.4 ± 36.9540.6 ± 40.0538.9 ± 43.24
Alopecia, CFB to C4D134.5 ± 35.6936.8 ± 41.5135.8 ± 40.75
Alopecia, CFB to C5D137.8 ± 35.2336.7 ± 37.3834.0 ± 39.65
Alopecia, CFB to C6D138.9 ± 35.9337.2 ± 40.1436.7 ± 38.83
Alopecia, CFB to C9D123.8 ± 37.6130.0 ± 44.6040.2 ± 43.08
Alopecia, CFB to C12D119.2 ± 35.9320.1 ± 37.9541.2 ± 41.72
Alopecia, CFB to C15D19.7 ± 33.135.1 ± 22.3537.5 ± 45.21
Alopecia, CFB to C18D10.8 ± 25.585.6 ± 27.8058.3 ± 50.00
Alopecia, CFB to C22D17.3 ± 32.0712.1 ± 28.2616.7 ± 23.57
Alopecia, CFB to C26D1-4.2 ± 22.002.0 ± 21.960 ± NA
Alopecia, CFB to C30D1-2.7 ± 21.342.4 ± 24.330 ± NA
Alopecia, CFB to C34D1-1.7 ± 17.014.8 ± 12.600 ± NA
Alopecia, CFB to C38D10 ± 19.255.6 ± 25.09—
Alopecia, CFB to C42D1-4.2 ± 11.79-8.3 ± 16.67100.0 ± NA
Alopecia, CFB to C46D1-5.6 ± 13.61-16.7 ± 23.570 ± NA
Alopecia, CFB to C50D10 ± 21.080 ± NA—
Alopecia, CFB to C54D15.6 ± 13.61-16.7 ± 23.57—
Alopecia, CFB to C58D10 ± 00 ± NA—
Alopecia, CFB to C62D10 ± 00 ± NA—
Alopecia, CFB to C66D1—0 ± NA—
Alopecia, CFB to EOT (~216 weeks)20.5 ± 38.5521.7 ± 41.5923.4 ± 39.25
Alopecia, CFB to SFU D30 (~220 weeks)12.4 ± 33.427.5 ± 26.6713.0 ± 32.94
Alopecia, CFB to SFU D90 (~229 weeks)9.5 ± 42.225.8 ± 39.764.2 ± 26.87
Pain in Chest, CFB to C2D1-2.3 ± 22.400 ± 21.912.4 ± 19.88
Pain in Chest, CFB to C3D1-2.7 ± 18.40-1.0 ± 21.634.0 ± 20.43
Pain in Chest, CFB to C4D1-1.8 ± 19.33-1.9 ± 21.16-1.0 ± 20.23
Pain in Chest, CFB to C5D1-0.9 ± 21.63-2.6 ± 19.45-1.3 ± 23.54
Pain in Chest, CFB to C6D1-0.7 ± 24.072.4 ± 19.440 ± 22.57
Pain in Chest, CFB to C9D12.6 ± 20.742.9 ± 23.694.6 ± 19.36
Pain in Chest, CFB to C12D1-0.5 ± 20.062.9 ± 25.2011.8 ± 20.21
Pain in Chest, CFB to C15D11.2 ± 14.290.9 ± 17.914.2 ± 11.79
Pain in Chest, CFB to C18D1-3.3 ± 18.181.1 ± 16.340 ± 0
Pain in Chest, CFB to C22D14.1 ± 19.99-6.1 ± 19.620 ± 0
Pain in Chest, CFB to C26D10 ± 18.93-3.9 ± 23.220 ± NA
Pain in Chest, CFB to C30D1-1.3 ± 17.95-4.8 ± 25.680 ± NA
Pain in Chest, CFB to C34D1-1.7 ± 20.160 ± 19.250 ± NA
Pain in Chest, CFB to C38D1-5.1 ± 12.52-5.6 ± 38.97—
Pain in Chest, CFB to C42D1-4.2 ± 21.360 ± 00 ± NA
Pain in Chest, CFB to C46D1-5.6 ± 13.610 ± 00 ± NA
Pain in Chest, CFB to C50D10 ± 00 ± NA—
Pain in Chest, CFB to C54D1-11.1 ± 17.210 ± 0—
Pain in Chest, CFB to C58D1-11.1 ± 19.250 ± NA—
Pain in Chest, CFB to C62D1-16.7 ± 23.570 ± NA—
Pain in Chest, CFB to C66D1—0 ± NA—
Pain in Chest, CFB to EOT (~216 weeks)7.5 ± 26.095.3 ± 23.602.1 ± 24.59
Pain in Chest, CFB to SFU D30 (~220 weeks)3.8 ± 21.046.7 ± 21.6212.1 ± 28.26
Pain in Chest, CFB to SFU D90 (~229 weeks)-7.1 ± 14.198.7 ± 20.64-4.2 ± 31.91
Pain in Arm or Shoulder, CFB to C2D11.0 ± 22.01-1.7 ± 21.33-0.3 ± 20.58
Pain in Arm or Shoulder, CFB to C3D1-0.4 ± 22.19-3.1 ± 24.450 ± 22.69
Pain in Arm or Shoulder, CFB to C4D1-0.8 ± 22.630 ± 23.650 ± 20.25
Pain in Arm or Shoulder, CFB to C5D12.9 ± 24.79-1.8 ± 25.99-0.6 ± 24.01
Pain in Arm or Shoulder, CFB to C6D11.0 ± 24.48-3.3 ± 22.452.0 ± 23.97
Pain in Arm or Shoulder, CFB to C9D15.5 ± 26.880.4 ± 26.08-1.1 ± 20.86
Pain in Arm or Shoulder, CFB to C12D16.6 ± 24.312.3 ± 24.073.9 ± 23.22
Pain in Arm or Shoulder, CFB to C15D17.3 ± 19.972.6 ± 24.64-4.2 ± 11.79
Pain in Arm or Shoulder, CFB to C18D15.0 ± 20.744.4 ± 24.34-8.3 ± 16.67
Pain in Arm or Shoulder, CFB to C22D16.5 ± 21.376.1 ± 16.700 ± 0
Pain in Arm or Shoulder, CFB to C26D16.3 ± 21.480 ± 20.410 ± NA
Pain in Arm or Shoulder, CFB to C30D113.3 ± 21.52-4.8 ± 22.100 ± NA
Pain in Arm or Shoulder, CFB to C34D113.3 ± 19.940 ± 27.220 ± NA
Pain in Arm or Shoulder, CFB to C38D12.6 ± 21.35-11.1 ± 50.18—
Pain in Arm or Shoulder, CFB to C42D14.2 ± 11.79-8.3 ± 16.670 ± NA
Pain in Arm or Shoulder, CFB to C46D15.6 ± 13.61-16.7 ± 23.5733.3 ± NA
Pain in Arm or Shoulder, CFB to C50D15.6 ± 25.09-33.3 ± NA—
Pain in Arm or Shoulder, CFB to C54D10 ± 29.81-33.3 ± 0—
Pain in Arm or Shoulder, CFB to C58D10 ± 33.33-33.3 ± NA—
Pain in Arm or Shoulder, CFB to C62D1-16.7 ± 23.57-33.3 ± NA—
Pain in Arm or Shoulder, CFB to C66D1—-33.3 ± NA—
Pain in Arm or Shoulder, CFB to EOT (~216 weeks)6.8 ± 27.276.6 ± 25.20-2.6 ± 23.23
Pain in Arm or Shoulder, CFB to SFU D30 (~220 weeks)7.6 ± 33.426.7 ± 26.375.8 ± 27.80
Pain in Arm or Shoulder, CFB to SFU D90 (~229 weeks)-7.1 ± 35.030 ± 33.3310.4 ± 29.11
Pain in Other Parts, CFB to C2D10.2 ± 28.09-0.3 ± 25.732.4 ± 25.31
Pain in Other Parts, CFB to C3D10.5 ± 28.04-3.3 ± 27.611.2 ± 30.37
Pain in Other Parts, CFB to C4D1-1.6 ± 26.35-1.7 ± 29.37-1.0 ± 29.57
Pain in Other Parts, CFB to C5D12.5 ± 30.53-0.3 ± 30.43-1.2 ± 30.35
Pain in Other Parts, CFB to C6D11.5 ± 29.390.3 ± 31.774.0 ± 28.28
Pain in Other Parts, CFB to C9D15.5 ± 29.09-2.1 ± 30.162.3 ± 26.62
Pain in Other Parts, CFB to C12D12.8 ± 25.04-1.7 ± 27.525.9 ± 24.25
Pain in Other Parts, CFB to C15D1-1.8 ± 23.501.7 ± 27.524.2 ± 21.36
Pain in Other Parts, CFB to C18D12.5 ± 15.81-3.3 ± 33.168.3 ± 16.67
Pain in Other Parts, CFB to C22D12.4 ± 18.84-10.6 ± 23.8716.7 ± 23.57
Pain in Other Parts, CFB to C26D15.4 ± 31.15-15.7 ± 37.490 ± NA
Pain in Other Parts, CFB to C30D12.7 ± 28.74-4.8 ± 28.810 ± NA
Pain in Other Parts, CFB to C34D11.7 ± 17.01-14.3 ± 17.820 ± NA
Pain in Other Parts, CFB to C38D17.7 ± 27.74-11.1 ± 34.43—
Pain in Other Parts, CFB to C42D1-4.2 ± 21.36-8.3 ± 16.670 ± NA
Pain in Other Parts, CFB to C46D10 ± 21.08-16.7 ± 23.5733.3 ± NA
Pain in Other Parts, CFB to C50D10 ± 21.080 ± NA—
Pain in Other Parts, CFB to C54D1-5.6 ± 25.09-33.3 ± 0—
Pain in Other Parts, CFB to C58D111.1 ± 19.25-33.3 ± NA—
Pain in Other Parts, CFB to C62D116.7 ± 23.57-33.3 ± NA—
Pain in Other Parts, CFB to C66D1—0 ± NA—
Pain in Other Parts, CFB to EOT (~216 weeks)5.4 ± 31.186.2 ± 32.756.7 ± 33.95
Pain in Other Parts, CFB to SFU D30(~220 weeks)2.9 ± 29.561.7 ± 31.488.7 ± 27.00
Pain in Other Parts, CFB to SFU D90 (~229 weeks)4.8 ± 25.684.3 ± 32.268.3 ± 25.82
SecondaryNumber of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings

ECGs were recorded after the participants were in a supine or semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes. ECG findings are summarized as clinically significant change from baseline worst case hierarchy: Yes \> No \> Not Applicable (NA).

Time frame:
Baseline (Day-1) up to Cycle 1 Day 1
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings
ParticipantsCobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)
No201615
Yes833
NA000
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Immune-mediate AEs (imAEs)

A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

Time frame:
Up to 329 weeks

Results for this outcome have not been posted.

SecondaryNumber of Participants With TEAEs Leading to Death and Treatment Discontinuation

A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.

Time frame:
Up to 329 weeks

Results for this outcome have not been posted.

SecondaryNumber of Participants Using Concomitant Medications

Number of participants using concomitant medications will be presented.

Time frame:
Up to 329 weeks

Results for this outcome have not been posted.

SecondaryNumber of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline

Blood samples will be collected for the analysis of hematology parameters.

Time frame:
Up to 329 weeks

Results for this outcome have not been posted.

SecondaryNumber of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline

Blood samples will be collected for the analysis of Clinical Chemistry parameters.

Time frame:
Up to 329 weeks

Results for this outcome have not been posted.

SecondaryNumber of Participants With Worst Case Thyroid Function Results by Maximum Grade Increase Post-Baseline Relative to Baseline

Blood samples will be collected for the analysis of thyroid function

Time frame:
Up to 329 weeks

Results for this outcome have not been posted.

SecondaryNumber of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline

Urine samples will be collected to analyze urine specific gravity.

Time frame:
Up to 329 weeks

Results for this outcome have not been posted.

SecondaryNumber of Participants With Worst Case Vital Signs Results Relative to Normal Range Post-Baseline Relative to Baseline

Vital signs will be assessed

Time frame:
Up to 329 weeks

Results for this outcome have not been posted.

SecondaryNumber of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Vital Signs

Vital signs will be assessed and presented

Time frame:
Baseline (Day -1) and Up to 281 weeks

Results for this outcome have not been posted.

SecondaryNumber of Participants With Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status

Performance status will be assessed using the ECOG performance status scale.

Time frame:
Up to 329 weeks

Results for this outcome have not been posted.

SecondaryNumber of Participants With Abnormal Physical Examinations

Number of participants with abnormal physical examinations will be presented

Time frame:
Up to approximately 234 weeks

No measurements were reported for this outcome.

Adverse events

Collected over All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cobolimab + Dostarlimab + Docetaxel (Arm A)227/305 (74.4%)102/302 (33.8%)285/302 (94.4%)
Dostarlimab + Docetaxel (Arm B)236/301 (78.4%)126/295 (42.7%)276/295 (93.6%)
Docetaxel (Arm C)116/152 (76.3%)52/144 (36.1%)136/144 (94.4%)
Most frequent serious events
Showing 10 of 180
Most frequent serious events
EventCobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)
PneumoniaInfections and infestations19/30224/29512/144
Febrile neutropeniaBlood and lymphatic system disorders9/30215/2952/144
DyspnoeaRespiratory, thoracic and mediastinal disorders4/3023/2954/144
PneumonitisRespiratory, thoracic and mediastinal disorders6/3026/2951/144
NeutropeniaBlood and lymphatic system disorders4/3025/2951/144
Pleural effusionRespiratory, thoracic and mediastinal disorders2/3025/2951/144
PneumothoraxRespiratory, thoracic and mediastinal disorders5/3022/2950/144
AnaemiaBlood and lymphatic system disorders2/3021/2952/144
Lower respiratory tract infectionInfections and infestations0/3022/2952/144
Respiratory tract infectionInfections and infestations4/3022/2952/144
Most frequent other events
Showing 10 of 42
Most frequent other events
EventCobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)
AnaemiaBlood and lymphatic system disorders105/30293/29541/144
NeutropeniaBlood and lymphatic system disorders95/30277/29538/144
FatigueGeneral disorders89/30288/29540/144
DiarrhoeaGastrointestinal disorders87/30287/29537/144
AlopeciaSkin and subcutaneous tissue disorders78/30269/29540/144
AstheniaGeneral disorders70/30279/29536/144
NauseaGastrointestinal disorders74/30268/29530/144
Decreased appetiteMetabolism and nutrition disorders61/30269/29527/144
DyspnoeaRespiratory, thoracic and mediastinal disorders52/30251/29527/144
Neuropathy peripheralNervous system disorders35/30229/29524/144

Baseline characteristics

Age, Continuous
Age, Continuous(YEARS)Cobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)Total
Mean63.7 ± 8.8664.3 ± 9.8564.0 ± 9.4564.0 ± 9.37
Sex: Female, Male
Sex: Female, Male(Participants)Cobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)Total
Female9810047245
Male207201105513
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cobolimab + Dostarlimab + Docetaxel (Arm A)Dostarlimab + Docetaxel (Arm B)Docetaxel (Arm C)Total
American Indian or Alaska Native75416
Asian374424105
Black or African American28111
White245224119588
Mixed Race0101
Unknown35210
Not Reported1114227
08

Study locations

163 sites
  • GSK Investigational Site
    Fountain Valley, California 92708, United States
  • GSK Investigational Site
    Walnut Creek, California 94596, United States
  • GSK Investigational Site
    Norwich, Connecticut 06360, United States
  • GSK Investigational Site
    Washington D.C., District of Columbia 20422, United States
  • GSK Investigational Site
    Honolulu, Hawaii 96819, United States
  • GSK Investigational Site
    Iowa City, Iowa 52242, United States
  • GSK Investigational Site
    Edgewood, Kentucky 41017, United States
  • GSK Investigational Site
    Las Vegas, Nevada 89144, United States
  • GSK Investigational Site
    Mineola, New York 11501, United States
  • GSK Investigational Site
    New York, New York 10016, United States
  • GSK Investigational Site
    White Plains, New York 10601, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15224, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15232, United States
  • GSK Investigational Site
    Sioux Falls, South Dakota 57105, United States
  • GSK Investigational Site
    Houston, Texas 77030, United States
  • GSK Investigational Site
    Fredericksburg, Virginia 22408, United States
  • GSK Investigational Site
    Tacoma, Washington 98405, United States
  • GSK Investigational Site
    Buenos Aires, C1426ABP, Argentina
  • GSK Investigational Site
    Cipoletti Rio Negro, R8324CVE, Argentina
  • GSK Investigational Site
    Ciudad Autonoma de Buenos Aire, 1425, Argentina
  • GSK Investigational Site
    Florida, 1602, Argentina
  • GSK Investigational Site
    La Rioja, F5300COE, Argentina
  • GSK Investigational Site
    Pergamino, B2700CPM, Argentina
  • GSK Investigational Site
    Rosario, S2000DBS, Argentina
  • GSK Investigational Site
    Viedma, R8500ACE, Argentina
  • GSK Investigational Site
    South Brisbane, Queensland 4101, Australia
  • GSK Investigational Site
    Ashford, South Australia 5037, Australia
  • GSK Investigational Site
    Hobart, Tasmania 7000, Australia
  • GSK Investigational Site
    Ballarat, Victoria 3350, Australia
  • GSK Investigational Site
    Melbourne, Victoria 3004, Australia
  • GSK Investigational Site
    Mount Waverley, Victoria 3350, Australia
  • GSK Investigational Site
    Aalst, 9300, Belgium
  • GSK Investigational Site
    Hasselt, 3500, Belgium
  • GSK Investigational Site
    Kortrijk, 8500, Belgium
  • GSK Investigational Site
    Blumenau, 89010340, Brazil
  • GSK Investigational Site
    Fortaleza, 60336-232, Brazil
  • GSK Investigational Site
    Porto Alegre, 90610000, Brazil
  • GSK Investigational Site
    Rio de Janeiro, 22061080, Brazil
  • GSK Investigational Site
    Rio de Janeiro, 22250-905, Brazil
  • GSK Investigational Site
    Salvador, 40170-110, Brazil
  • GSK Investigational Site
    São Paulo, 04014-002, Brazil
  • GSK Investigational Site
    Greater Sudbury, Ontario P3E 5J1, Canada
  • GSK Investigational Site
    Kingston, Ontario K7L 2V7, Canada
  • GSK Investigational Site
    Oshawa, Ontario L1G 2B9, Canada
  • GSK Investigational Site
    Greenfield Park, Quebec J4V 2H1, Canada
  • GSK Investigational Site
    Montreal, Quebec H3T 1E2, Canada
  • GSK Investigational Site
    Helsinki, 00180, Finland
  • GSK Investigational Site
    Kuopio, 70210, Finland
  • GSK Investigational Site
    Créteil, 94010, France
  • GSK Investigational Site
    Grenoble, 38043, France
  • GSK Investigational Site
    Marseille, 13009, France
  • GSK Investigational Site
    Nice, 06189, France
  • GSK Investigational Site
    Quimper, 29107, France
  • GSK Investigational Site
    Rennes, 35033, France
  • GSK Investigational Site
    Tours, 37044, France
  • GSK Investigational Site
    Augsburg, 86156, Germany
  • GSK Investigational Site
    Bad Berka, 99437, Germany
  • GSK Investigational Site
    Berlin, 12200, Germany
  • GSK Investigational Site
    Bonn, 53113, Germany
  • GSK Investigational Site
    Cologne, 51109, Germany
  • GSK Investigational Site
    Dresden, 01307, Germany
  • GSK Investigational Site
    Essen, 45147, Germany
  • GSK Investigational Site
    Frankfurt, 60488, Germany
  • GSK Investigational Site
    Frankfurt, 60590, Germany
  • GSK Investigational Site
    Halle, 06120, Germany
  • GSK Investigational Site
    Heidelberg, 69126, Germany
  • GSK Investigational Site
    Karlsruhe, 76137, Germany
  • GSK Investigational Site
    München, 80336, Germany
  • GSK Investigational Site
    München, 81925, Germany
  • GSK Investigational Site
    Oldenburg, 26121, Germany
  • GSK Investigational Site
    Athens, 115 27, Greece
  • GSK Investigational Site
    Athens, 11526, Greece
  • GSK Investigational Site
    Athens, 11528, Greece
  • GSK Investigational Site
    Athens, 12462, Greece
  • GSK Investigational Site
    Larissa, 41100, Greece
  • GSK Investigational Site
    Pylaia Thessaloniki, 570 01, Greece
  • GSK Investigational Site
    Rio Patras, 26504, Greece
  • GSK Investigational Site
    Thessaloniki, 55236, Greece
  • GSK Investigational Site
    Thessaloniki, 57010, Greece
  • GSK Investigational Site
    Ancona, 60126, Italy
  • GSK Investigational Site
    Avellino, 83100, Italy
  • GSK Investigational Site
    Florence, 50134, Italy
  • GSK Investigational Site
    Milan, 20132, Italy
  • GSK Investigational Site
    Milan, 20133, Italy
  • GSK Investigational Site
    Monza, 20900, Italy
  • GSK Investigational Site
    Naples, 80131, Italy
  • GSK Investigational Site
    Orbassano to, 10043, Italy
  • GSK Investigational Site
    Perugia, 06156, Italy
  • GSK Investigational Site
    Siena, 53100, Italy
  • GSK Investigational Site
    Kyoto, 612-8555, Japan
  • GSK Investigational Site
    Miyagi, 981-1293, Japan
  • GSK Investigational Site
    Osaka, 591-8555, Japan
  • GSK Investigational Site
    Yamaguchi, 755-0241, Japan
  • GSK Investigational Site
    Guadajalara, 44280, Mexico
  • GSK Investigational Site
    Mexico City, 03100, Mexico
  • GSK Investigational Site
    Mexico City, 03810, Mexico
  • GSK Investigational Site
    Mexico City, 06700, Mexico
  • GSK Investigational Site
    Mexico City, CP 14080, Mexico
  • GSK Investigational Site
    Monterrey, 64460, Mexico
  • GSK Investigational Site
    Puebla Puebla, 72560, Mexico

Showing the first 100 of 163 sites across 24 countries.

09

References and documents

Study documents

  • Study protocol · Sep 4, 2025
  • Statistical analysis plan · Mar 25, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04655976
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Dec 7, 2020
Start date
Dec 8, 2020
Primary completion
Jun 5, 2025
Completion
Mar 30, 2027 (estimated)
Results posted
Jul 1, 2026
Last update
Jul 1, 2026

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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