Trial · NCT03976323
Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)
NCT03976323, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2025-02-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006). Trials, record NCT03976323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03976323
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)
- NCT number
- NCT03976323
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,003 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Carcinoma, Nonsquamous Non-small-cell Lung
- Interventions
- Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin, Olaparib
- First posted
- 2019-06-06
- Last updated
- 2026-09-28
- Other registries' IDs
- eudract:2018-004720-11
- Results first posted
- 2025-02-06
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to ~31 months | PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. 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 also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS was analyzed by the non-parametric Kaplan-Meier (K-M) method. The protocol specified final analysis of PFS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. |
| Primary | Overall Survival (OS) | Up to ~51 months | OS was defined as the time from randomization to death due to any cause. OS was analyzed by the non-parametric K-M method. Participants without documented death at the time of analyses were censored at the date of last known to be alive. The protocol specified final analysis of OS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. |
| Secondary | Number of Participants Who Experience One or More Adverse Events (AEs) | Up to ~5 years | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported. The protocol specified final analysis will be presented for the first pembrolizumab course. |
| Secondary | Number of Participants Who Discontinue Study Treatment Due to an AE | Up to ~5 years | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. The protocol specified final analysis will be presented for the first pembrolizumab course. |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score | Baseline and Week 24 | EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in GHS and QoL combined score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. |
| Secondary | Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score | Up to ~24 months | EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participant responses to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in GHS-QoL combined score. TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome was not done in the Induction Phase. |
| Secondary | Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score | Baseline and Week 24 | EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding cough (Item 1): "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 0-100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. |
| Secondary | TTD in EORTC QLQ-LC13 Cough (Item 1) Scale Score | Up to ~24 months | EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding cough (Item 1): "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 0-100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 1). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. |
| Secondary | Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score | Baseline and Week 24 | EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding chest pain (Item 10): "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. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. |
| Secondary | TTD in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score | Up to ~24 months | EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding chest pain (Item 10): "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 is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in chest pain (Item 10). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Up to ~31 months | All randomized participants in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to ~51 months | All randomized participants in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experience One or More Adverse Events (AEs) | Up to ~5 years | |||
| SECONDARY | Number of Participants Who Discontinue Study Treatment Due to an AE | Up to ~5 years | |||
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score | Baseline and Week 24 | All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment and had at least 1 patient reported outcome (PRO) assessment available. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score | Up to ~24 months | All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment, had at least 1 PRO assessment and had data available for this EORTC QLQ-C30 outcome measure. Per protocol, analysis for this outcome was not planned or conducted in the Induction Phase. | Months | MEDIAN |
| SECONDARY | Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score | Baseline and Week 24 | All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment and had at least 1 PRO assessment available. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | TTD in EORTC QLQ-LC13 Cough (Item 1) Scale Score | Up to ~24 months | All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment, had at least 1 PRO assessment and had data available for this EORTC QLQ-LC13 outcome measure. Per protocol, analysis for this outcome was not planned or conducted in the Induction Phase. | Months | MEDIAN |
| SECONDARY | Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score | Baseline and Week 24 | All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment and had at least 1 PRO assessment available. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | TTD in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score | Up to ~24 months | All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment, had at least 1 PRO assessment and had EORTC QLQ-LC13 data available for this outcome measure. Per protocol, analysis for this outcome was not planned or conducted in the Induction Phase. | Months | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Pembrolizumab + Olaparib (Maintenance Phase) | 7.1 | 95% Confidence Interval 5.6 to 8.7 | Months | |
| Progression-free Survival (PFS) | Pembrolizumab + Pemetrexed (Maintenance Phase) | 8.3 | 95% Confidence Interval 6.9 to 11.5 | Months | |
| Overall Survival (OS) | Pembrolizumab + Olaparib (Maintenance Phase) | 20.7 | 95% Confidence Interval 18.0 to 24.8 | Months | |
| Overall Survival (OS) | Pembrolizumab + Pemetrexed (Maintenance Phase) | 23.0 | 95% Confidence Interval 19.0 to 26.4 | Months | |
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score | Pembrolizumab + Olaparib (Maintenance Phase) | -5.34 | 95% Confidence Interval -7.78 to -2.90 | Scores 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 / Quality of Life (Items 29 and 30) Scale Score | Pembrolizumab + Pemetrexed (Maintenance Phase) | -3.44 | 95% Confidence Interval -5.90 to -0.98 | Scores on a scale | |
| Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score | Pembrolizumab + Olaparib (Maintenance Phase) | 19.81 | 95% Confidence Interval 15.97 to NA | Months | |
| Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score | Pembrolizumab + Pemetrexed (Maintenance Phase) | 17.28 | 95% Confidence Interval 9.46 to NA | Months | |
| Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score | Pembrolizumab + Olaparib (Maintenance Phase) | -1.98 | 95% Confidence Interval -4.90 to 0.94 | Scores on a scale | |
| Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score | Pembrolizumab + Pemetrexed (Maintenance Phase) | -1.82 | 95% Confidence Interval -4.77 to 1.12 | Scores on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Phase | STARTED | Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase) | 1,003 | |
| Induction Phase | STARTED | Pembrolizumab + Olaparib (Maintenance Phase) | 0 | |
| Induction Phase | STARTED | Pembrolizumab + Pemetrexed (Maintenance Phase) | 0 | |
| Induction Phase | COMPLETED | Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase) | 672 | |
| Induction Phase | COMPLETED | Pembrolizumab + Olaparib (Maintenance Phase) | 0 | |
| Induction Phase | COMPLETED | Pembrolizumab + Pemetrexed (Maintenance Phase) | 0 | |
| Induction Phase | NOT COMPLETED | Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase) | 331 | |
| Induction Phase | NOT COMPLETED | Pembrolizumab + Olaparib (Maintenance Phase) | 0 | |
| Induction Phase | NOT COMPLETED | Pembrolizumab + Pemetrexed (Maintenance Phase) | 0 | |
| Maintenance Phase | STARTED | Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase) | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,715
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase) | 385 | 1,003 | 432 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab (First Course) + Olaparib (Maintenance Phase) | 122 | 337 | 176 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab (First Course) + Pemetrexed (Maintenance Phase) | 125 | 332 | 199 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab (Second Course) + Olaparib (Maintenance Phase) | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab (Second Course) + Pemetrexed (Maintenance Phase) | 2 | 13 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase) | 141 | 1,003 | 208 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab (First Course) + Olaparib (Maintenance Phase) | 48 | 337 | 83 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab (First Course) + Pemetrexed (Maintenance Phase) | 19 | 332 | 41 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab (Second Course) + Olaparib (Maintenance Phase) | 0 | 7 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab (Second Course) + Pemetrexed (Maintenance Phase) | 0 | 13 | 0 |
1 to 10 of 1,715Source ClinicalTrials.gov
See all 1,715 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase) | 116 | 1,003 |
| Total, all-cause mortality | Pembrolizumab (First Course) + Olaparib (Maintenance Phase) | 233 | 337 |
| Total, all-cause mortality | Pembrolizumab (First Course) + Pemetrexed (Maintenance Phase) | 233 | 335 |
| Total, all-cause mortality | Pembrolizumab (Second Course) + Olaparib (Maintenance Phase) | 0 | 7 |
| Total, all-cause mortality | Pembrolizumab (Second Course) + Pemetrexed (Maintenance Phase) | 2 | 13 |
| Total, other adverse events | Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase) | 872 | 1,003 |
| Total, other adverse events | Pembrolizumab (First Course) + Olaparib (Maintenance Phase) | 298 | 337 |
| Total, other adverse events | Pembrolizumab (First Course) + Pemetrexed (Maintenance Phase) | 289 | 332 |
| Total, other adverse events | Pembrolizumab (Second Course) + Olaparib (Maintenance Phase) | 2 | 7 |
| Total, other adverse events | Pembrolizumab (Second Course) + Pemetrexed (Maintenance Phase) | 9 | 13 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39521434 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03976323
GET https://conductscience.org/api/trials/v1/NCT03976323/results?page=2