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CompletedNCT03976362Updated Feb 25, 2026Results posted

A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)

A Phase 3 interventional study of Pembrolizumab and Carboplatin in Carcinoma, Squamous Cell, Non-small-cell Lung, sponsored by Merck Sharp & Dohme LLC. Completed at 178 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
851
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are:

  1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
  2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).

As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.

Read the detailed description

This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance olaparib placebo. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance olaparib placebo until centrally verified progressive disease (PD), intolerable toxicities, or physician decision.

As of Amendment 07, participants actively taking placebo will discontinue taking the placebo intervention and continue in the study.

02

Conditions studied

  • Carcinoma, Squamous Cell, Non-small-cell Lung

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Keywords

  • PD-1
  • PD L1
  • PD L2
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 851 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) 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

  1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
  2. Have Stage IV squamous NSCLC.
  3. Have measurable disease based on RECIST 1.1.
  4. Have not received prior systemic treatment for their advanced/metastatic NSCLC.

  5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.

    Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.

  6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention
  7. Have a life expectancy of at least 3 months.
  8. Has adequate organ function.
  9. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
  10. Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.

Exclusion criteria

Exclusion Criteria:

  1. Has non-squamous histology NSCLC.
  2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
  3. Has known active central nervous system metastases and/or carcinomatous meningitis.
  4. Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib.
  5. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  6. Has an active autoimmune disease that has required systemic treatment in past 2 years.
  7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
  8. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
  9. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
  10. Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
  11. Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
  12. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
851 participants (actual)

Study arms

  • Experimental
    Pembrolizumab + Carboplatin + Taxane + Olaparib

    For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.

    Biological: Pembrolizumab · Drug: Carboplatin · Drug: Paclitaxel · Drug: Nab-paclitaxel · Drug: Olaparib

  • Active comparator
    Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo

    For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.

    Biological: Pembrolizumab · Drug: Carboplatin · Drug: Paclitaxel · Drug: Nab-paclitaxel · Drug: Placebo

Interventions

  • BiologicalPembrolizumab

    IV infusion

    Also known as: MK-3475

  • DrugCarboplatin

    IV infusion

    Also known as: PARAPLATIN®

  • DrugPaclitaxel

    IV infusion

    Also known as: TAXOL®, ONXAL™

  • DrugNab-paclitaxel

    IV infusion

    Also known as: ABRAXANE®

  • DrugOlaparib

    Tablets

    Also known as: LYNPARZA®

  • DrugPlacebo

    Placebo to olaparib, tablets

06

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS)

    Progression-free Survival was defined as the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, progressive disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 is presented. PFS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Up to approximately 39 months

  2. Overall Survival (OS)

    Overall survival was the time from the date of randomization to death due to any cause. OS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Up to approximately 46 months

Secondary outcomes

  1. Number of Participants With One or More Adverse Events (AEs)

    An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who reported 1 or more AEs is presented. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Up to approximately 4 years

  2. Number of Participants Who Discontinued Study Intervention Due to an AE

    An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who discontinued study intervention due to an AE is presented. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Up to approximately 4 years

  3. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/ Quality of Life (QoL) (Items 29 and 30) Combined Scale Score

    EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Baseline and Week 24

  4. Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 and 30) Scale Score

    TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) and QoL score (EORTC QLQ-C30 Item 30). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10- point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Up to approximately 2 years

  5. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score

    The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Baseline and Week 24

  6. Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score

    The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough scale score. The TTD for cough (Item 1) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Up to approximately 2 years

  7. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score

    The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Baseline and Week 24

  8. Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score

    The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in chest pain scale score. The TTD for chest pain (Item 10) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Up to approximately 2 years

  9. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Baseline and Week 24

  10. Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Item 8 scale score. The TTD for dyspnea (Item 8) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Up to approximately 2 years

  11. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score is presented. Change from baseline score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Baseline and Week 24

  12. Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. The TTD for physical functioning (Item 1-5) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

    Time frame: Up to approximately 2 years

07

Results

Posted Nov 6, 2024

Participant flow

Induction Phase
Participant flow — Induction Phase
MilestonePembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)Pembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Started85100
Completed59100
Not completed26000
Withdrew: Failure to meet maintenance randomization criteria19800
Withdrew: Death6200
Maintenance Phase
Participant flow — Maintenance Phase
MilestonePembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)Pembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Started0296295
Pembro + olaparib/placebo (second course pembro only)079
Completed000
Not completed0296295
Withdrew: Participants ongoing0106103
Withdrew: Withdrawal by subject044
Withdrew: Failure to meet randomization criteria001
Withdrew: Death0186187

Outcome measures

PrimaryProgression-free Survival (PFS)

Progression-free Survival was defined as the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, progressive disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 is presented. PFS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Up to approximately 39 months
Reported as:
Median · Months
Progression-free Survival (PFS)
MonthsPembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Progression-free Survival (PFS)8.3 (6.7 to 9.7)5.4 (4.1 to 5.6)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · Log Rank · p = 0.0040 (One-sided p-value based on log-rank test stratified by Eastern Cooperative Cancer Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.) · Hazard ratio (hr): 0.77 · 95% CI 0.63 to 0.93Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.
PrimaryOverall Survival (OS)

Overall survival was the time from the date of randomization to death due to any cause. OS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Up to approximately 46 months
Reported as:
Median · Months
Overall Survival (OS)
MonthsPembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Overall Survival (OS)19.1 (15.9 to 22.2)18.6 (16.0 to 21.6)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · Log Rank · p = 0.5481 (One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.) · Hazard ratio (hr): 1.01 · 95% CI 0.83 to 1.24Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.
SecondaryNumber of Participants With One or More Adverse Events (AEs)

An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who reported 1 or more AEs is presented. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Up to approximately 4 years

Results for this outcome have not been posted.

SecondaryNumber of Participants Who Discontinued Study Intervention Due to an AE

An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who discontinued study intervention due to an AE is presented. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Up to approximately 4 years

Results for this outcome have not been posted.

SecondaryChange From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/ Quality of Life (QoL) (Items 29 and 30) Combined Scale Score

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · Score on a Scale
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/ Quality of Life (QoL) (Items 29 and 30) Combined Scale Score
Score on a ScalePembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/ Quality of Life (QoL) (Items 29 and 30) Combined Scale Score-1.24 (-3.68 to 1.19)-1.62 (-4.11 to 0.88)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · t-test, 2 sided · p = 0.8238 (Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.) · Difference in ls means: 0.37 · 95% CI -2.91 to 3.66Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
SecondaryTime to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 and 30) Scale Score

TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) and QoL score (EORTC QLQ-C30 Item 30). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10- point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Up to approximately 2 years
Reported as:
Median · Months
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 and 30) Scale Score
MonthsPembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 and 30) Scale Score29.08 (17.94 to NA)29.01 (12.55 to NA)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · Log Rank · p = 0.3083 (Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.) · Hazard ratio (hr): 0.87 · 95% CI 0.66 to 1.14Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.
SecondaryChange From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score

The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · Score on a Scale
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
Score on a ScalePembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score2.42 (-0.93 to 5.77)0.74 (-2.69 to 4.17)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · t-test, 2 sided · p = 0.4686 (Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.) · Difference in least square means: 1.68 · 95% CI -2.87 to 6.23Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
SecondaryTime to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score

The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough scale score. The TTD for cough (Item 1) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Up to approximately 2 years
Reported as:
Median · Months
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
MonthsPembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score24.18 (15.64 to NA)NA (16.56 to NA)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · Log Rank · p = 0.9174 (Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.) · Hazard ratio (hr): 1.01 · 95% CI 0.76 to 1.35Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.
SecondaryChange From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score

The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · Score on a Scale
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
Score on a ScalePembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score6.35 (3.95 to 8.76)2.52 (0.06 to 4.98)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · t-test, 2 sided · p = 0.0245 (Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.) · Difference in least square means: 3.83 · 95% CI 0.50 to 7.16Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
SecondaryTime to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score

The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in chest pain scale score. The TTD for chest pain (Item 10) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Up to approximately 2 years
Reported as:
Median · Months
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
MonthsPembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale ScoreNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · Log Rank · p = 0.2133 (Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.) · Hazard ratio (hr): 1.24 · 95% CI 0.88 to 1.75Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.
SecondaryChange From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · Score on a Scale
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
Score on a ScalePembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score-1.08 (-4.49 to 2.34)-1.25 (-4.74 to 2.24)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · t-test, 2 sided · p = 0.9381 (Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.) · Hazard ratio (hr): 0.18 · 95% CI -4.27 to 4.62Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
SecondaryTime to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Item 8 scale score. The TTD for dyspnea (Item 8) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Up to approximately 2 years
Reported as:
Median · Months
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
MonthsPembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale ScoreNA (NA to NA)NA (14.72 to NA)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · Log Rank · p = 0.8464 (Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.) · Hazard ratio (hr): 0.97 · 95% CI 0.72 to 1.31Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.
SecondaryChange From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score is presented. Change from baseline score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · Score on Scale
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
Score on ScalePembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score-2.04 (-4.38 to 0.31)0.77 (-1.62 to 3.17)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · t-test, 2 sided · p = 0.0870 (Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.) · Difference in least square means: -2.81 · 95% CI -6.02 to 0.41Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
SecondaryTime to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. The TTD for physical functioning (Item 1-5) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Time frame:
Up to approximately 2 years
Reported as:
Median · Months
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
MonthsPembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score22.80 (10.05 to NA)NA (27.50 to NA)
Statistical analysis
  • Pembro + Olaparib (Maintenance Phase) vs Pembro + Placebo (Maintenance Phase) · Log Rank · p = 0.0020 (Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.) · Hazard ratio (hr): 1.60 · 95% CI 1.18 to 2.16Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.

Adverse events

Collected over Up to approximately 4 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pembro + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)101/851 (11.9%)220/851 (25.9%)787/851 (92.5%)
Pembro+Olaparib (Maintenance Phase )188/296 (63.5%)97/294 (33%)265/294 (90.1%)
Pembro+Placebo (Maintenance Phase)189/295 (64.1%)77/292 (26.4%)240/292 (82.2%)
Pembro + Olaparib (Second Course Pembro Only)0/7 (0%)2/7 (28.6%)4/7 (57.1%)
Pembro + Placebo (Second Course Pembro Only)2/9 (22.2%)1/9 (11.1%)6/9 (66.7%)
Most frequent serious events
Showing 10 of 200
Most frequent serious events
EventPembro + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)Pembro+Olaparib (Maintenance Phase )Pembro+Placebo (Maintenance Phase)Pembro + Olaparib (Second Course Pembro Only)Pembro + Placebo (Second Course Pembro Only)
Atrial fibrillationCardiac disorders3/8513/2941/2921/70/9
AtelectasisRespiratory, thoracic and mediastinal disorders2/8511/2940/2921/70/9
Hypertensive crisisVascular disorders0/8510/2941/2921/70/9
Atrial flutterCardiac disorders2/8510/2940/2921/70/9
PneumoniaInfections and infestations36/85113/29411/2920/71/9
AnaemiaBlood and lymphatic system disorders4/85110/2942/2920/70/9
COVID-19 pneumoniaInfections and infestations4/85110/2948/2920/70/9
COVID-19Infections and infestations8/8519/2942/2920/70/9
PneumonitisRespiratory, thoracic and mediastinal disorders1/8517/2943/2920/70/9
Febrile neutropeniaBlood and lymphatic system disorders14/8511/2940/2920/70/9
Most frequent other events
Showing 10 of 54
Most frequent other events
EventPembro + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)Pembro+Olaparib (Maintenance Phase )Pembro+Placebo (Maintenance Phase)Pembro + Olaparib (Second Course Pembro Only)Pembro + Placebo (Second Course Pembro Only)
AnaemiaBlood and lymphatic system disorders369/851130/29445/2921/71/9
NeutropeniaBlood and lymphatic system disorders279/85157/29416/2920/70/9
AlopeciaSkin and subcutaneous tissue disorders279/8511/2945/2920/70/9
NauseaGastrointestinal disorders215/85169/29435/2920/70/9
ThrombocytopeniaBlood and lymphatic system disorders200/85156/29419/2920/71/9
LeukopeniaBlood and lymphatic system disorders168/85144/29413/2920/70/9
Decreased appetiteMetabolism and nutrition disorders140/85154/29447/2920/70/9
ConstipationGastrointestinal disorders147/85126/29429/2920/70/9
AstheniaGeneral disorders115/85142/29437/2920/70/9
DizzinessNervous system disorders25/85117/29411/2921/70/9

Baseline characteristics

Pembro + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase): All enrolled participants who were not randomized into maintenance phase Pembro + Olaparib (Maintenance Phase): Intention-to-Treat (ITT) Population which included all randomized participants post induction phase Pembro + Placebo (Maintenance Phase): Intention-to-Treat (ITT) Population which included all randomized participants post induction phase

Age, Continuous
Age, Continuous(Years)Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)Pembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)Total
Mean65.5 ± 8.664.2 ± 8.864.6 ± 7.864.4 ± 8.4
Sex: Female, Male
Sex: Female, Male(Participants)Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)Pembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)Total
Female555560170
Male205241235681
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)Pembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)Total
Hispanic or Latino344748129
Not Hispanic or Latino211239235685
Unknown or Not Reported15101237
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)Pembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)Total
American Indian or Alaska Native591125
Asian766351190
Native Hawaiian or Other Pacific Islander0011
Black or African American44311
White164214219597
More than one race2136
Unknown or Not Reported95721
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)(Participants)Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)Pembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)Total
Grade 008382165
Grade 10213213426
Response
Response(Participants)Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)Pembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)Total
Complete Response (CR)l/Partial Response (PR)0211218429
Stable Disease (SD)08476160
Progressive Disease (PD)0101
Missing0011
Programmed Cell Death-Ligand 1 (PD-L1) Expression Level: Tumor Proportion Score (TPS)
Programmed Cell Death-Ligand 1 (PD-L1) Expression Level: Tumor Proportion Score (TPS)(Participants)Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)Pembro + Olaparib (Maintenance Phase)Pembro + Placebo (Maintenance Phase)Total
Tumor Proportion Score (TPS)<50%187208208603
TPS≥50%648585234
Not Evaluable5229
Missing4105
08

Study locations

178 sites
  • Alabama Oncology Bruno Cancer Center ( Site 0001)
    Birmingham, Alabama 35205, United States
  • Disney Family Cancer Center ( Site 0005)
    Burbank, California 91505, United States
  • Boca Raton Regional Hospital ( Site 0018)
    Boca Raton, Florida 33486, United States
  • Mid-Florida Cancer Centers ( Site 0022)
    Orange City, Florida 32763, United States
  • H. Lee Moffitt Cancer Center and Research Institute ( Site 0024)
    Tampa, Florida 33612, United States
  • Columbus Regional Research Institute ( Site 0099)
    Columbus, Georgia 31904, United States
  • Mount Sinai Hospital Medical Center ( Site 0035)
    Chicago, Illinois 60608, United States
  • Oncology of Northshore ( Site 0036)
    Rolling Meadows, Illinois 60008, United States
  • Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)
    Merrillville, Indiana 46410, United States
  • MedStar Franklin Square Medical Center ( Site 0044)
    Baltimore, Maryland 21237, United States
  • Barbara Ann Karmanos Cancer Institute ( Site 0046)
    Detroit, Michigan 48201, United States
  • Hattiesburg Clinic ( Site 0051)
    Hattiesburg, Mississippi 39401, United States
  • Frontier Oncology ( Site 0052)
    Billings, Montana 59102, United States
  • Bozeman Health Deaconness Cancer Center ( Site 0053)
    Bozeman, Montana 59715, United States
  • Waverly Hematology Oncology ( Site 0054)
    Cary, North Carolina 27518, United States
  • Thompson Cancer Survival Center ( Site 2812)
    Knoxville, Tennessee 37804, United States
  • Renovatio Clinical ( Site 0074)
    The Woodlands, Texas 77380, United States
  • Cancer Care Northwest ( Site 0083)
    Spokane Valley, Washington 99216, United States
  • Hospital Italiano Regional del Sur ( Site 0509)
    Bahía Blanca, Buenos Aires B8001HXM, Argentina
  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)
    Mar del Plata, Buenos Aires B7600FZO, Argentina
  • Hospital Britanico de Buenos Aires ( Site 0500)
    Buenos Aires, Buenos Aires F.D. C1280AEB, Argentina
  • Instituto Medico Rio Cuarto ( Site 0501)
    Río Cuarto, Córdoba Province X5800AEV, Argentina
  • Sanatorio Parque ( Site 0515)
    Rosario, Santa Fe Province S2000DSV, Argentina
  • Centro Oncológico de Rosario ( Site 0507)
    Rosario, Santa Fe Province S2000KZE, Argentina
  • Centro Medico San Roque ( Site 0506)
    San Miguel de Tucumán, Tucumán Province T4000IAK, Argentina
  • Hospital Italiano de Buenos Aires ( Site 0511)
    Buenos Aires, C1199ABB, Argentina
  • Clínica Universitaria Reina Fabiola ( Site 0505)
    Córdoba, X5004FHP, Argentina
  • Sanatorio Privado San Geronimo S.R.L ( Site 0510)
    Santa Fe, S3000AOL, Argentina
  • Liverpool Hospital ( Site 1201)
    Liverpool, New South Wales 2170, Australia
  • Southern Medical Day Care Centre ( Site 1200)
    Wollongong, New South Wales 2500, Australia
  • Townsville General Hospital ( Site 1202)
    Townsville, Queensland 4814, Australia
  • Monash Cancer Centre ( Site 1205)
    Clayton, Victoria 3168, Australia
  • Social Medical Center - Otto Wagner Hospital ( Site 1301)
    Vienna, State of Vienna 1145, Austria
  • Innsbruck LKH ( Site 1302)
    Innsbruck, Tyrol 6020, Austria
  • Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
    Linz, Upper Austria 4020, Austria
  • Klinikum Wels-Grieskirchen ( Site 1304)
    Wels, Upper Austria 4600, Austria
  • Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
    Vienna, 1210, Austria
  • Instituto do Cancer do Ceara ( Site 0251)
    Fortaleza, Ceará 60430-230, Brazil
  • Hospital Sao Rafael ( Site 0258)
    Salvador - BA, Estado de Bahia 41253-190, Brazil
  • Oncologica do Brasil ( Site 0256)
    Belém, Pará 66053-000, Brazil
  • Hospital Tacchini ( Site 0265)
    Bento Gonçalves, Rio Grande do Sul 95700-000, Brazil
  • Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0255)
    Porto Alegre, Rio Grande do Sul 90050-170, Brazil
  • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0252)
    Itajaí, Santa Catarina 88301-220, Brazil
  • Hospital de Base de Sao Jose de Rio Preto ( Site 0254)
    Sao Jose Rio Preto, São Paulo 15090-000, Brazil
  • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0253)
    Rio de Janeiro, 20230-130, Brazil
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0250)
    São Paulo, 01246-000, Brazil
  • Hospital Paulistano - Amil Clinical Research ( Site 0263)
    São Paulo, 01321-001, Brazil
  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260)
    São Paulo, 01321-001, Brazil
  • Nova Scotia Health Authority ( Site 0103)
    Halifax, Nova Scotia B3H 1V7, Canada
  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107)
    Hamilton, Ontario L8V5C2, Canada
  • Kingston Health Sciences Centre ( Site 0102)
    Kingston, Ontario K7L 2V7, Canada
  • Stronach Regional Cancer Centre ( Site 0100)
    Newmarket, Ontario L3Y 2P9, Canada
  • CISSS de la Monteregie-Centre ( Site 0101)
    Greenfield Park, Quebec J4V 2H1, Canada
  • Hopital Cite de la Sante de Laval ( Site 0105)
    Laval, Quebec H7M 3L9, Canada
  • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
    Montreal, Quebec H3T 1M5, Canada
  • CIUSSS de la Mauricie et du Centre du Quebec ( Site 0106)
    Trois-Rivières, Quebec G8Z 3R9, Canada
  • Centre Hospitalier De Chauny ( Site 1411)
    Chauny, Aisne 02300, France
  • CHU Caen ( Site 1406)
    Caen, Calvados 14033, France
  • CHU Angers ( Site 1405)
    Angers, Maine-et-Loire 49100, France
  • Institut De Cancerologie De Lorraine ( Site 1409)
    Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54519, France
  • Hopital Robert Schuman ( Site 1402)
    Vantoux, Moselle 57070, France
  • Centre Jean Perrin ( Site 1407)
    Clermont-Ferrand, Puy-de-Dome 63011, France
  • Centre Hospitalier de Pau ( Site 1412)
    Pau, Pyrenees-Atlantiques 64000, France
  • CHU de Rouen ( Site 1403)
    Rouen, Seine-Maritime 76000, France
  • Hopital d'Instruction des Armees Begin ( Site 1413)
    Saint-Mandé, Val-de-Marne 94163, France
  • Studienzentrum Aschaffenburg ( Site 1575)
    Aschaffenburg, Bavaria 63739, Germany
  • Klinikum der LMU ( Site 1550)
    Munich, Bavaria 80336, Germany
  • Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573)
    Munich, Bavaria 81925, Germany
  • Universitaetsklinikum Regensburg ( Site 1562)
    Regensburg, Bavaria 93042, Germany
  • Klinikum Wuerzburg Mitte gGmbH ( Site 1559)
    Würzburg, Bavaria 97074, Germany
  • Universitaetsklinikum Frankfurt ( Site 1563)
    Frankfurt am Main, Hesse 60590, Germany
  • Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)
    Immenhausen, Hesse 34376, Germany
  • Universitaetsmedizin Goettingen ( Site 1557)
    Göttingen, Lower Saxony 37075, Germany
  • Universitaetsklinikum Bonn ( Site 1574)
    Bonn, North Rhine-Westphalia 53105, Germany
  • Kliniken Essen Mitte ( Site 1567)
    Essen, North Rhine-Westphalia 45136, Germany
  • InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1564)
    Koblenz, Rhineland-Palatinate 56068, Germany
  • Helios Klinikum Erfurt GmbH ( Site 1552)
    Erfurt, Thuringia 99089, Germany
  • Katholisches Marienkrankenhaus gGmbH ( Site 1572)
    Hamburg, 22087, Germany
  • National Hospital Organization Nagoya Medical Center ( Site 0806)
    Nagoya, Aichi-ken 460-0001, Japan
  • Aichi Cancer Center Hospital ( Site 0803)
    Nagoya, Aichi-ken 464-8681, Japan
  • National Cancer Center Hospital East ( Site 0801)
    Kashiwa, Chiba 277-8577, Japan
  • Kurume University Hospital ( Site 0814)
    Kurume, Fukuoka 830-0011, Japan
  • Kanazawa University Hospital ( Site 0811)
    Kanazawa, Ishikawa-ken 920-8641, Japan
  • Kanagawa Cancer Center ( Site 0807)
    Yokohama, Kanagawa 241-8515, Japan
  • Sendai Kousei Hospital ( Site 0812)
    Sendai, Miyagi 980-0873, Japan
  • Kansai Medical University Hospital ( Site 0804)
    Hirakata, Osaka 573-1191, Japan
  • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
    Sakai, Osaka 591-8555, Japan
  • Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)
    Sunto-gun, Shizuoka 411-8777, Japan
  • National Hospital Organization Kyushu Medical Center ( Site 0805)
    Fukuoka, 810-8563, Japan
  • Niigata Cancer Center Hospital ( Site 0808)
    Niigata, 951-8566, Japan
  • Okayama University Hospital ( Site 0810)
    Okayama, 700-8558, Japan
  • Osaka International Cancer Institute ( Site 0809)
    Osaka, 541-8567, Japan
  • The Cancer Institute Hospital of JFCR ( Site 0800)
    Tokyo, 135-8550, Japan
  • Investigacion Onco Farmaceutica S de RL de CV ( Site 0300)
    La Paz, Baja California Sur 23040, Mexico
  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334)
    Guadalajara, Jalisco 44280, Mexico
  • Arke Estudios Clinicos ( Site 0333)
    Mexico City, Mexico City 06700, Mexico
  • Axis Heilsa S. de R.L. de C.V. ( Site 0301)
    Monterrey, Nuevo León 64060, Mexico
  • CLIMERS Clinical Medical Research ( Site 0306)
    Orizaba, Veracruz 94300, Mexico
  • FAICIC Clinical Research ( Site 0303)
    Veracruz, 91900, Mexico
  • MidCentral DHB Palmerston North Hospital ( Site 1102)
    Palmerston North, Manawatu-Wanganui 4414, New Zealand

Showing the first 100 of 178 sites across 20 countries.

09

References and documents

Publications

  • Hochmair M, Schenker M, Cobo Dols M, Kim TM, Ozyilkan O, Smagina M, Leonova V, Kato T, Fedenko A, De Angelis F, Rittmeyer A, Gray JE, Greystoke A, Aggarwal H, Huang Q, Zhao B, Lara-Guerra H, Nadal E. Pembrolizumab With or Without Maintenance Olaparib for Metastatic Squamous NSCLC That Responded to First-Line Pembrolizumab Plus Chemotherapy. J Thorac Oncol. 2025 Feb;20(2):203-218. doi: 10.1016/j.jtho.2024.10.012. Epub 2024 Oct 28. PubMed 39477187 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 31, 2024

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

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

10

Updates

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

Registry details

Key details

Study ID
NCT03976362
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jun 6, 2019
Start date
Jun 28, 2019
Primary completion
Sep 21, 2023
Completion
Jan 30, 2026
Results posted
Nov 6, 2024
Last update
Feb 25, 2026

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

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 completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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