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CompletedNCT02395172Updated Aug 3, 2020Results posted

Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)

A Phase 3 interventional study of Avelumab and Docetaxel in Carcinoma, Non-Small-Cell Lung, sponsored by EMD Serono Research & Development Institute, Inc.. Completed at 260 sites in 29 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-03.

Sponsored by EMD Serono Research & Development Institute, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
792
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung

Keywords

  • Avelumab
  • MSB0010718C
  • Non-Small Cell Lung Cancer
  • Anti-PD-L1
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's enrollment of 792 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

EMD Serono Research & Development Institute, Inc. is the lead sponsor of 85 studies on the registry; 8 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 38 (83%) 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

  • Signed written informed consent before any trial related procedure
  • Male or female participants aged greater than or equal to (>=) 18 years
  • Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 7 unstained tumor slides suitable for PD-L1 expression assessment
  • Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central laboratory
  • Participants with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression

  • Participants must have progressed after an acceptable therapy defined as follows:

    1. Participants must have progressed during or after a minimum of 2 cycles of 1 course of a platinum based combination therapy administered for the treatment of a metastatic disease. A history of continuation (use of a non platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination OR
    2. Participants must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease
  • Participants with non-squamous cell NSCLC of unknown epidermal growth factor receptor (EGFR) mutation status will require testing (local laboratory, or central laboratory if local testing is not available). Participants with a tumor that harbors an activating EGFR mutation will not be eligible
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
  • Estimated life expectancy of more than 12 weeks
  • Adequate hematological function defined by White Blood Cell (WBC) count >= 2.5 × 10\^9/L with absolute neutrophil count (ANC) >= 1.5 × 10\^9/L, lymphocyte count >=0.5 × 10\^9/L, platelet count >= 100 × 10\^9/L, and hemoglobin >= 9 gram per deciliter (g/dL) (may have been transfused)
  • Adequate hepatic function defined by a total bilirubin level less than or equal to (\<=) 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \<= 2.5 × ULN for all participants
  • Adequate renal function defined by an estimated creatinine clearance > 30 milliliter per minute (mL/min) according to the Cockcroft-Gault formula (or local institutional standard method).

Other protocol defined inclusion criteria could apply

Exclusion criteria

Exclusion criteria

  • In the United States only, participants with a squamous cell histology will be excluded
  • Systemic anticancer therapy administered after disease progression during or following a platinum based combination
  • Participants with non-squamous cell NSCLC whose disease harbors EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Participants of unknown ALK and/or EGFR mutation status will require testing at screening (local laboratory, or central laboratory if local testing is not available)
  • Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4).
  • Concurrent anticancer treatment
  • Major surgery for any reason, except diagnostic biopsy, within 4 weeks of randomization and/or if the participant has not fully recovered from the surgery within 4 weeks of randomization
  • Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment.

  • All participants with brain metastases, except those meeting the following criteria:

    1. Brain metastases have been treated locally, and
    2. No ongoing neurological symptoms that are related to the brain localization of the disease

  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:

    1. Participants with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
    2. Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses less than or equal to (\<=)10 milligram (mg) or equivalent prednisone per day
    3. Administration of steroids through a route known to result in a minimal systemic exposure are acceptable
  • Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be \<=10 mg per day of equivalent prednisone

Other protocol defined exclusion criteria could apply

05

Study design

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

Study arms

  • Experimental
    Avelumab

    Drug: Avelumab

  • Active comparator
    Docetaxel

    Drug: Docetaxel

Interventions

  • DrugAvelumab

    Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.

  • DrugDocetaxel

    Participants received 75 mg per square meter (m\^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)

    The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

    Time frame: Time from date of randomization up to 1420 days

Secondary outcomes

  1. Overall Survival (OS) Time in Full Analysis Set Population

    The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

    Time frame: Time from date of randomization up to 1420 days

  2. Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population

    PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.

    Time frame: Time from date of randomization up to 907 days

  3. Progression-Free Survival (PFS) Time in Full Analysis Set Population

    PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.

    Time frame: Time from date of randomization up to 907 days

  4. Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population

    Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.

    Time frame: Time from date of randomization up to 907 days

  5. Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population

    Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.

    Time frame: Time from date of randomization up to 907 days

  6. Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population

    Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

    Time frame: Time from date of randomization up to 907 days

  7. Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population

    Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

    Time frame: Time from date of randomization up to 907 days

  8. Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)

    The EQ-5D-5L health outcome questionnaire was a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defined health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items were combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score was -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest was 1.00 (no problems in all 5 dimensions).

    Time frame: Baseline, End of treatment visit (up to Week 124)

  9. Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)

    EQ-5D-5L was comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.

    Time frame: Baseline, End of treatment visit (up to Week 124)

  10. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT)

    EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

    Time frame: Baseline, End of treatment visit (up to Week 124)

  11. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT)

    EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).

    Time frame: Baseline, End of treatment visit (up to Week 124)

  12. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death

    An Adverse event (AE) was defined as any unfavorable and unintended sign (including clinically significant abnormal laboratory, vital signs and 12-lead Electrocardiogram findings), symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.

    Time frame: Time from date of randomization up to 1420 days

  13. Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity

    Treatment Emergent Adverse Events were graded as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03). Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL), Grade 4 refers to Life-threatening consequences; where urgent intervention indicated, Grade 5 refers to the death related to adverse event.

    Time frame: Time from date of randomization up to 1420 days

  14. Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score

    ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. The participants with missing worst post baseline score were also reported. ECOG performance status was reported in terms of number of participants with Baseline value vs. worst post-baseline value (i.e. highest score) combination.

    Time frame: Time from date of randomization up to 1420 days

  15. Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab

    Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.

    Time frame: Time from date of randomization up to 1420 days

07

Results

Posted Dec 13, 2018

Participant flow

Participant flow — Overall Study
MilestoneAvelumabDocetaxel
Started396396
Treated393365
Completed393365
Not completed331
Withdrew: Participants randomized but not treated331

Outcome measures

PrimaryOverall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)

The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Time frame:
Time from date of randomization up to 1420 days
Reported as:
Median · months
Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)
monthsAvelumabDocetaxel
Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)11.4 (9.4 to 13.8)10.6 (8.5 to 12.9)
Statistical analysis
  • Avelumab vs Docetaxel · Log Rank · p = = 0.0721 · Hazard ratio (hr): 0.87 · 95% CI 0.71 to 1.05
SecondaryOverall Survival (OS) Time in Full Analysis Set Population

The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.

Time frame:
Time from date of randomization up to 1420 days
Reported as:
Median · months
Overall Survival (OS) Time in Full Analysis Set Population
monthsAvelumabDocetaxel
Overall Survival (OS) Time in Full Analysis Set Population10.6 (9.2 to 12.3)9.9 (8.1 to 11.9)
Statistical analysis
  • Avelumab vs Docetaxel · Hazard ratio (hr): 0.90 · 95% CI 0.77 to 1.05
SecondaryProgression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population

PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Time frame:
Time from date of randomization up to 907 days
Reported as:
Median · months
Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population
monthsAvelumabDocetaxel
Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population3.4 (2.7 to 4.9)4.1 (3.0 to 5.3)
Statistical analysis
  • Avelumab vs Docetaxel · Hazard ratio (hr): 1.01 · 95% CI 0.80 to 1.27
SecondaryProgression-Free Survival (PFS) Time in Full Analysis Set Population

PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Time frame:
Time from date of randomization up to 907 days
Reported as:
Median · months
Progression-Free Survival (PFS) Time in Full Analysis Set Population
monthsAvelumabDocetaxel
Progression-Free Survival (PFS) Time in Full Analysis Set Population2.8 (2.7 to 3.5)4.2 (3.3 to 5.2)
Statistical analysis
  • Avelumab vs Docetaxel · Hazard ratio (hr): 1.17 · 95% CI 0.98 to 1.41
SecondaryNumber of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population

Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.

Time frame:
Time from date of randomization up to 907 days
Reported as:
Count of participants · Participants
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population
ParticipantsAvelumabDocetaxel
Complete Response52
Partial Response5442
Stable Disease129158
Non-complete Response/ Non-progressive Disease513
Progressive Disease15082
Not Evaluable5399
SecondaryNumber of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population

Confirmed BOR was determined according to RECIST v1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.

Time frame:
Time from date of randomization up to 907 days
Reported as:
Count of participants · Participants
Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population
ParticipantsAvelumabDocetaxel
Complete Response41
Partial Response4630
Stable Disease86104
Non-complete Response/ Non-progressive Disease412
Progressive Disease9357
Not Evaluable3161
SecondaryPercentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population

Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

Time frame:
Time from date of randomization up to 907 days
Reported as:
Number · percentage of participants
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population
percentage of participantsAvelumabDocetaxel
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population14.9 (11.5 to 18.8)11.1 (8.2 to 14.6)
Statistical analysis
  • Avelumab vs Docetaxel · Odds ratio (or): 1.40 · 95% CI 0.92 to 2.13
SecondaryPercentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population

Percentage of participants with objective response (CR plus PR) according to RECIST v1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

Time frame:
Time from date of randomization up to 907 days
Reported as:
Number · percentage of participants
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population
percentage of participantsAvelumabDocetaxel
Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population18.9 (14.4 to 24.2)11.7 (8.1 to 16.2)
Statistical analysis
  • Avelumab vs Docetaxel · Odds ratio (or): 1.76 · 95% CI 1.08 to 2.86
SecondaryChange From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)

The EQ-5D-5L health outcome questionnaire was a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defined health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items were combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score was -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest was 1.00 (no problems in all 5 dimensions).

Time frame:
Baseline, End of treatment visit (up to Week 124)
Reported as:
Mean · units on a scale
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)
units on a scaleAvelumabDocetaxel
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)-0.1245 ± 0.28021-0.0988 ± 0.26615
SecondaryChange From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)

EQ-5D-5L was comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.

Time frame:
Baseline, End of treatment visit (up to Week 124)
Reported as:
Mean · millimeter
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)
millimeterAvelumabDocetaxel
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)-8.1 ± 22.06-7.0 ± 21.12
SecondaryChange From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT)

EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

Time frame:
Baseline, End of treatment visit (up to Week 124)
Reported as:
Mean · units on a scale
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT)
units on a scaleAvelumabDocetaxel
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT)-9.79 ± 24.506-9.44 ± 18.933
SecondaryChange From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT)

EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).

Time frame:
Baseline, End of treatment visit (up to Week 124)
Reported as:
Mean · units on a scale
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT)
units on a scaleAvelumabDocetaxel
Dyspnea9.95 ± 22.0948.52 ± 21.285
Coughing-0.58 ± 30.263-2.03 ± 32.582
Hemoptysis0.19 ± 14.191-0.34 ± 16.832
Sore Mouth0.78 ± 17.6433.72 ± 24.920
Dysphagia5.62 ± 18.4014.23 ± 21.538
Peripheral Neuropathy0.19 ± 20.5509.81 ± 30.015
Alopecia-3.10 ± 20.78930.80 ± 42.582
Pain in Chest4.84 ± 28.9930.34 ± 26.935
Pain in Arm or Shoulder5.62 ± 28.8520.85 ± 29.439
Pain in Other Parts8.77 ± 34.4106.60 ± 30.978
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death

An Adverse event (AE) was defined as any unfavorable and unintended sign (including clinically significant abnormal laboratory, vital signs and 12-lead Electrocardiogram findings), symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.

Time frame:
Time from date of randomization up to 1420 days
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death
ParticipantsAvelumabDocetaxel
TEAEs375346
TESAEs167145
Drug Related TEAEs252313
TEAEs Leading to Death6451
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity

Treatment Emergent Adverse Events were graded as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03). Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL), Grade 4 refers to Life-threatening consequences; where urgent intervention indicated, Grade 5 refers to the death related to adverse event.

Time frame:
Time from date of randomization up to 1420 days
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity
ParticipantsAvelumabDocetaxel
Grade 3 or Higher209247
Grade 4 or Higher87122
Grade 56351
SecondaryNumber of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score

ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. The participants with missing worst post baseline score were also reported. ECOG performance status was reported in terms of number of participants with Baseline value vs. worst post-baseline value (i.e. highest score) combination.

Time frame:
Time from date of randomization up to 1420 days
Reported as:
Count of participants · Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score
ParticipantsAvelumabDocetaxel
Baseline score 0, worst post-baseline score 05255
Baseline score 0, worst post-baseline score 16741
Baseline score 0, worst post-baseline score 21912
Baseline score 0, worst post-baseline score 352
Baseline score 0, worst post-baseline score 401
Baseline score 0, worst post-baseline score 510
Baseline score 0, worst post-baseline Missing06
Baseline score 1, worst post-baseline score 061
Baseline score 1, worst post-baseline score 1157172
Baseline score 1, worst post-baseline score 24741
Baseline score 1, worst post-baseline score 3238
Baseline score 1, worst post-baseline score 432
Baseline score 1, worst post-baseline score 511
Baseline score 1, worst post-baseline Missing1223
SecondaryNumber of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab

Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay were tested for neutralizing antibodies (nAb). Number of participants with ADA or nAb positive results for Avelumab were reported.

Time frame:
Time from date of randomization up to 1420 days
Reported as:
Count of participants · Participants
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab
ParticipantsAvelumab
ADAs to Avelumab58
NAbs to Avelumab14

Adverse events

Collected over Time from date of randomization up to 1420 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Avelumab316/393 (80.4%)167/393 (42.5%)320/393 (81.4%)
Docetaxel297/365 (81.4%)145/365 (39.7%)307/365 (84.1%)
Most frequent serious events
Showing 10 of 177
Most frequent serious events
EventAvelumabDocetaxel
Disease progressionGeneral disorders41/39326/365
Febrile neutropeniaBlood and lymphatic system disorders0/39322/365
PneumoniaInfections and infestations9/39319/365
DyspnoeaRespiratory, thoracic and mediastinal disorders11/3937/365
NeutropeniaBlood and lymphatic system disorders0/39310/365
Pleural effusionRespiratory, thoracic and mediastinal disorders10/3933/365
Infusion related reactionInjury, poisoning and procedural complications10/3930/365
AstheniaGeneral disorders6/3933/365
DeathGeneral disorders6/3934/365
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders6/3933/365
Most frequent other events
Showing 10 of 38
Most frequent other events
EventAvelumabDocetaxel
AlopeciaSkin and subcutaneous tissue disorders3/39397/365
AnaemiaBlood and lymphatic system disorders50/39381/365
Decreased appetiteMetabolism and nutrition disorders79/39376/365
CoughRespiratory, thoracic and mediastinal disorders77/39346/365
DyspnoeaRespiratory, thoracic and mediastinal disorders75/39354/365
DiarrhoeaGastrointestinal disorders44/39367/365
FatigueGeneral disorders70/39366/365
AstheniaGeneral disorders55/39364/365
NauseaGastrointestinal disorders56/39357/365
Infusion related reactionInjury, poisoning and procedural complications56/3938/365

Baseline characteristics

Full analysis set (FAS) included all participants who were randomized to study.

Age, Continuous
Age, Continuous(years)AvelumabDocetaxelTotal
Mean62.8 ± 9.9962.5 ± 9.6562.7 ± 9.81
Sex: Female, Male
Sex: Female, Male(Participants)AvelumabDocetaxelTotal
Female127123250
Male269273542
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AvelumabDocetaxelTotal
Hispanic or Latino5942101
Not Hispanic or Latino297307604
Unknown or Not Reported404787
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)AvelumabDocetaxelTotal
American Indian or Alaska Native011
Asian102114216
Native Hawaiian or Other Pacific Islander101
Black or African American516
White273262535
Not collected at the site141428
Other145
08

Study locations

260 sites
  • University of Alabama
    Tuscaloosa, Alabama 35401, United States
  • Mayo Clinic
    Scottsdale , Phoenix, Arizona 85259-5499, United States
  • Pacific Cancer Medical Center, Inc.
    Anaheim, California 92801, United States
  • Healing Hands Oncology and Medical Care
    Lawndale, California 90260, United States
  • Sutter Gould Medical Foundation
    Modesto, California 95355, United States
  • Sharp Memorial Hospital
    San Diego, California 92123, United States
  • Lynn Cancer Institute Center
    Boca Raton, Florida 33486, United States
  • University Cancer Institute
    Boynton Beach, Florida 33426, United States
  • Holy Cross Hospital Inc.
    Fort Lauderdale, Florida 33308, United States
  • Florida Cancer Specialists-Broadway
    Fort Myers, Florida 33916, United States
  • Florida Cancer Specialists
    Saint Petersburg, Florida 33705, United States
  • Florida Cancer Specialists
    West Palm Beach, Florida 33401, United States
  • Northeast Georgia Cancer Care, LLC
    Athens, Georgia 30607, United States
  • Metairie Oncologist, LLC
    Metairie, Louisiana 70006, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • Hematology Oncology Associates of Rockland
    Nyack, New York 10960, United States
  • Novant Health Oncology Specialists
    Winston-Salem, North Carolina 27103, United States
  • Oncology Hematology Care
    Cincinnati, Ohio 45242, United States
  • Signal Point Clinical Research Center
    Middletown, Ohio 45042, United States
  • Mercy Clinic Oklahoma Communities, Inc.
    Oklahoma City, Oklahoma 73120-9309, United States
  • Abington Memorial Hospital
    Abington, Pennsylvania 19001, United States
  • Penn State Univ. Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • Center for Biomedical Research, LLC
    Knoxville, Tennessee 37909, United States
  • SCRI - Tennessee Oncology
    Nashville, Tennessee 37203, United States
  • The Center for Cancer and Blood Disorders
    Fort Worth, Texas 76104, United States
  • University of Texas Health Science Center at Tyler
    Tyler, Texas 75708, United States
  • MultiCare Health System
    Tacoma, Washington 98405, United States
  • Hospital Italiano Regional del Sur
    Bahia Blanca, B8001HXM, Argentina
  • Clínica Universitaria Privada Reina Fabiola
    Barrio General Paz, X5004FHP, Argentina
  • Centro de Oncologia e Investigacion Buenos Aires
    Berazategui, B1880BBF, Argentina
  • Instituto Medico Especializado Alexander Fleming
    Ciudad Autonoma Buenos Aires, C1426ANZ, Argentina
  • CEMIC
    Ciudad Autonoma Buenos Aires, C1431FWO, Argentina
  • Instituto DAMIC Fundacion Rusculleda
    Cordoba, X5003DCE, Argentina
  • Centro Oncologico Riojano Integral (Cori)
    La Rioja, F5300COE, Argentina
  • Centro Oncologico de Parana
    Parana, 3100, Argentina
  • Hospital Universitario Austral
    Pilar, B1629ODT, Argentina
  • Instituto Gamma
    Rosario, S2000CRF, Argentina
  • Sanatorio Parque S.A.
    Rosario, S2000DSV, Argentina
  • Instituto de Oncología de Rosario
    Rosario, S2000KZE, Argentina
  • Centro Medico San Roque S.R.L.
    San Miguel de Tucuman, 4000, Argentina
  • Ballarat Base Hospital
    Ballarat, 3350, Australia
  • Box Hill Hospital
    Box Hill, 3128, Australia
  • Coffs Harbour Base Hospital
    Coffs Harbour, 2450, Australia
  • Lyell McEwin Hospital
    Elizabeth Vale, 5112, Australia
  • Greenslopes Private Hospital
    Greenslopes, 4120, Australia
  • Lismore Base Hospital
    Lismore, 2480, Australia
  • Royal Melbourne Hospital
    Parkville, 3050, Australia
  • St John of God Hospital
    Subiaco, 6008, Australia
  • Princess Alexandra Hospital
    Woolloongabba, 4102, Australia
  • UZ Antwerpen
    Edegem, 2650, Belgium
  • Grand Hôpital de Charleroi
    Gilly, 6060, Belgium
  • UZ Leuven
    Leuven, 3000, Belgium
  • Centre Hospitalier de l'Ardenne
    Libramont, 6800, Belgium
  • C. H. U. Sart Tilman
    Liège, 4000, Belgium
  • AZ Delta
    Roeselare, 8800, Belgium
  • Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda
    Belo Horizonte, 30110-921, Brazil
  • CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
    Florianópolis, 88034-000, Brazil
  • Hospital de Caridade de Ijuí
    Ijuí, 98700-000, Brazil
  • Clínica de Neoplasias Litoral Ltda.
    Itajaí, 88310-110, Brazil
  • CMiP - Centro Mineiro de Pesquisa
    Juiz de Fora, 36010-570, Brazil
  • Hospital Bruno Born
    Lajeado, 95900-000, Brazil
  • Liga Norte-Rio-Grandense Contra o Câncer
    Natal, 59075-740, Brazil
  • Oncosinos - Clínica de Oncologia - Hospital Regina
    Novo Hamburgo, 93510-250, Brazil
  • CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo
    Passo Fundo, 99010-260, Brazil
  • Hospital Mãe de Deus
    Porto Alegre, 90110-270, Brazil
  • Hospital São Lucas da PUCRS
    Porto Alegre, 90610-000, Brazil
  • COI - Clínicas Oncológicas Integradas
    Rio de Janeiro, 22793-080, Brazil
  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
    Santo André, 09060-650, Brazil
  • IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"
    Sorocaba, 18030-075, Brazil
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
    São José do Rio Preto, 15090-000, Brazil
  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
    São Paulo, 01246-000, Brazil
  • UMHAT 'Dr. Georgi Stranski', EAD
    Pleven, 5800, Bulgaria
  • Complex Oncological Center - Plovdiv, EOOD
    Plovdiv, 4004, Bulgaria
  • MHAT "Serdika", EOOD
    Sofia, 1303, Bulgaria
  • MHAT 'Tokuda Hospital Sofia', AD
    Sofia, 1407, Bulgaria
  • Shato, Ead
    Sofia, 1756, Bulgaria
  • MHAT 'Sv. Marina', EAD
    Varna, 9010, Bulgaria
  • Instituto de Terapias Oncologicas Providencia
    Santiago, 7500000, Chile
  • FALP - Fundación Arturo López Pérez
    Santiago, 7500921, Chile
  • CIEC - Centro Internacional de Estudios Clínicos
    Santiago, 8420383, Chile
  • Instituto Clinico Oncologico del Sur (ICOS)
    Temuco, Chile
  • Centro de Investigaciones Clinicas Viña del Mar
    Viña del Mar, 2540364, Chile
  • Hospital Clinico Viña del Mar
    Viña del Mar, Chile
  • Fundacion Cardioinfantil Instituto de Cardiologia
    Bogota, 110131, Colombia
  • Instituto Nacional de Cancerologia E.S.E.
    Bogota, 111511, Colombia
  • Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
    Bogota, Colombia
  • Administradora Country S.A.
    Bogotá, Colombia
  • Fundación Valle del Lilí
    Cali, 760032, Colombia
  • Centro Medico Imbanaco
    Cali, 760042, Colombia
  • Hemato Oncologos S.A.
    Cali, Colombia
  • Instituto de Cancerologia S.A.
    Medellin, Colombia
  • Hospital Pablo Tobón Uribe
    Medellín, 050034, Colombia
  • IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.
    Monteria, Colombia
  • General Hospital Dubrovnik
    Dubrovnik, 20000, Croatia
  • General Hospital Zadar
    Zadar, 23000, Croatia
  • Clinical Hospital Centar "Sestre Milosrdnice"
    Zagreb, 10000, Croatia
  • University Clinic for Pulmonary Diseases
    Zagreb, 10000, Croatia
  • Masarykuv onkologicky ustav
    Brno, 65653, Czechia
  • Nemocnice Novy Jicin a.s.
    Novy Jicin, 74101, Czechia
  • Multiscan s.r.o.
    Pardubice, 53203, Czechia

Showing the first 100 of 260 sites across 29 countries.

09

References and documents

Publications

  • Coon CD, Schlichting M, Zhang X. Interpreting Within-Patient Changes on the EORTC QLQ-C30 and EORTC QLQ-LC13. Patient. 2022 Nov;15(6):691-702. doi: 10.1007/s40271-022-00584-w. Epub 2022 Jun 30. PubMed 35771392 ↗
  • Hrinczenko B, Iannotti N, Goel S, Spigel D, Safran H, Taylor MH, Bennouna J, Wong DJ, Kelly K, Verschraegen C, Bajars M, Manitz J, Ruisi M, Gulley JL. Long-term avelumab in advanced non-small-cell lung cancer: summaries and post hoc analyses from JAVELIN Solid Tumor. Future Oncol. 2022 Apr;18(11):1333-1342. doi: 10.2217/fon-2021-0930. Epub 2022 Feb 11. PubMed 35144482 ↗
  • Park K, Ozguroglu M, Vansteenkiste J, Spigel D, Yang JC, Bajars M, Ruisi M, Manitz J, Barlesi F. Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial. Lung Cancer. 2021 Apr;154:92-98. doi: 10.1016/j.lungcan.2021.01.026. Epub 2021 Feb 6. PubMed 33636453 ↗
  • Barlesi F, Vansteenkiste J, Spigel D, Ishii H, Garassino M, de Marinis F, Ozguroglu M, Szczesna A, Polychronis A, Uslu R, Krzakowski M, Lee JS, Calabro L, Aren Frontera O, Ellers-Lenz B, Bajars M, Ruisi M, Park K. Avelumab versus docetaxel in patients with platinum-treated advanced non-small-cell lung cancer (JAVELIN Lung 200): an open-label, randomised, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1468-1479. doi: 10.1016/S1470-2045(18)30673-9. Epub 2018 Sep 24. Erratum In: Lancet Oncol. 2018 Nov;19(11):e581. doi: 10.1016/S1470-2045(18)30771-X. PubMed 30262187 ↗

Study documents

  • Statistical analysis plan · Dec 11, 2017
  • Study protocol · Jan 10, 2017

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

Individual participant data

Plan to share: Yes — Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02395172
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
Responsible party
Sponsor
First posted
Mar 20, 2015
Start date
Mar 24, 2015
Primary completion
Nov 22, 2017
Completion
Dec 3, 2019
Results posted
Dec 13, 2018
Last update
Aug 3, 2020

Study contacts

Medical Responsible
study director · EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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