Trial · NCT03829319
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)
NCT03829319, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2025-02-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006). Trials, record NCT03829319. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03829319
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)
- NCT number
- NCT03829319
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 761 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Nonsquamous Non-small Cell Lung Cancer
- Interventions
- Pembrolizumab, Carboplatin, Cisplatin, Pemetrexed, Lenvatinib, Placebo matching lenvatinib
- First posted
- 2019-02-04
- Last updated
- 2026-02-05
- Other registries' IDs
- eudract:2018-003824-35
- Results first posted
- 2025-02-21
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With a Dose-limiting Toxicity (DLT) | Cycle 1; each cycle is 21 days (up to 21 days) | Dose-limiting toxicity using Common Terminology Criteria for Adverse Events v4.0 for grading, is defined as any of the following hematologic toxicities: 1) Grade 4 neutropenia, 2) Grade 3 or 4 febrile neutropenia, 3) thrombocytopenia \<25,000 cells/mm\^3 associated with bleeding and/or which requires platelet transfusion, or any of the following non-hematologic toxicities: 4) any other Grade 4 or 5 toxicity, 5) Grade 3 toxicities lasting \>3 days (exclusions apply), 6) Grade 3 hypertension not controlled by medication, 7) Grade 3 or above gastrointestinal perforation, 8) Grade 3 or above wound dehiscence requiring medical or surgical intervention, 9) any grade thromboembolic event, or 10) any Grade 3 nonhematologic laboratory value if medical intervention is required or the abnormality leads to hospitalization. |
| Primary | Part 1: Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 48 months | An adverse event 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 of more adverse events during Part 1 of this study will be presented. |
| Primary | Part 1: Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to approximately 58 months | An adverse event 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 medication due to and adverse event during Part 1 of this study will be presented. |
| Primary | Part 2: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 36 months | PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, 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 demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented. |
| Primary | Part 2: Overall Survival (OS) | Up to approximately 47 months | OS is defined as the time from randomization to the time of death from any cause. OS is presented. |
| Secondary | Part 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 19 months | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR as assessed per modified RECIST 1.1 will be presented. |
| Secondary | Part 2: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 48 months | For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed per modified RECIST 1.1 will be presented. |
| Secondary | Part 2: Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 58 months | An adverse event 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 experienced one of more adverse events during Part 2 of this study were presented. |
| Secondary | Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to approximately 58 months | An adverse event 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 discontinued study treatment during Part 2 of this study were presented. |
| Secondary | Part 2: Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Items 29 and 30) Score | Baseline and Week 27 | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are each scored on a 7-point scale (1=Very poor to 7=Excellent). The two raw scores were averaged into a combined score, then normalized using linear transformation so each participant's score ranged from 0 to 100 (0=Worst overall health/quality of life and 100=Best overall health/quality of life). The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score is presented |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With a Dose-limiting Toxicity (DLT) | Cycle 1; each cycle is 21 days (up to 21 days) | The analysis population consisted of all participants enrolled in Part 1 who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 48 months | The analysis population consisted of all participants enrolled in Part 1 who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to approximately 58 months | The analysis population consisted of all participants enrolled in Part 1 who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 36 months | The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response. | Months | MEDIAN |
| PRIMARY | Part 2: Overall Survival (OS) | Up to approximately 47 months | The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response. | Months | MEDIAN |
| SECONDARY | Part 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 19 months | The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response. | Percentage of Participants | NUMBER |
| SECONDARY | Part 2: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 48 months | The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response. | Months | MEDIAN |
| SECONDARY | Part 2: Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 58 months | The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to approximately 58 months | The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2: Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Items 29 and 30) Score | Baseline and Week 27 | The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Items 29 and 30 assessment data available. | Score on a Scale | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Number of Participants With a Dose-limiting Toxicity (DLT) | Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 2 | Participants | ||
| Part 1: Number of Participants Who Experienced an Adverse Event (AE) | Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 13 | Participants | ||
| Part 1: Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 9 | Participants | ||
| Part 2: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 12.1 | 95% Confidence Interval 10.4 to 14.1 | Months | |
| Part 2: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | 9.5 | 95% Confidence Interval 8.3 to 10.7 | Months | |
| Part 2: Overall Survival (OS) | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 21.8 | 95% Confidence Interval 18.6 to 24.0 | Months | |
| Part 2: Overall Survival (OS) | Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | 22.1 | 95% Confidence Interval 19.7 to 24.2 | Months | |
| Part 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 57.1 | 95% Confidence Interval 50.1 to 63.8 | Percentage of Participants | |
| Part 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | 50.7 | 95% Confidence Interval 43.8 to 57.6 | Percentage of Participants | |
| Part 2: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 1.6 | Full Range 1.1 to 15.4 | Months |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 13 | |
| Overall Study | STARTED | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 375 | |
| Overall Study | STARTED | Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | 373 | |
| Overall Study | Treated During First Course | Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 13 | |
| Overall Study | Treated During First Course | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 373 | |
| Overall Study | Treated During First Course | Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | 372 | |
| Overall Study | Treated During Second Course | Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 1 | |
| Overall Study | Treated During Second Course | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 3 | |
| Overall Study | Treated During Second Course | Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | 5 | |
| Overall Study | COMPLETED | Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events2,580
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 | Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 1 | 13 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 192 | 373 | 394 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | 220 | 372 | 419 |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Second Course: Pembrolizumab Only From Pembrolizumab+Chemotherapy+Lenvatinib | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Second Course: Pembrolizumab+Chemotherapy+Lenvatinib | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Second Course: Pembrolizumab+Chemotherapy+Placebo | 0 | 7 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 1 | 13 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 4 | 373 | 9 |
| other | Atrial fibrillation | Cardiac disorders | Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | 1 | 372 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Part 1 Second Course: Pembrolizumab Only From Pembrolizumab+Chemotherapy+Lenvatinib | 0 | 1 | 0 |
1 to 10 of 2,580Source ClinicalTrials.gov
See all 2,580 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 9 | 13 |
| Total, all-cause mortality | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 278 | 375 |
| Total, all-cause mortality | Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | 266 | 373 |
| Total, all-cause mortality | Part 1 Second Course: Pembrolizumab Only From Pembrolizumab+Chemotherapy+Lenvatinib | 0 | 1 |
| Total, all-cause mortality | Part 2 Second Course: Pembrolizumab+Chemotherapy+Lenvatinib | 3 | 3 |
| Total, all-cause mortality | Part 2 Second Course: Pembrolizumab+Chemotherapy+Placebo | 3 | 7 |
| Total, other adverse events | Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 13 | 13 |
| Total, other adverse events | Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib | 366 | 373 |
| Total, other adverse events | Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo | 363 | 372 |
| Total, other adverse events | Part 1 Second Course: Pembrolizumab Only From Pembrolizumab+Chemotherapy+Lenvatinib | 1 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40419140 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib vs Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo: Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Trial comparisons |
| Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib vs Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo: Part 2: Number of Participants Who Experienced an Adverse Event (AE) | Trial comparisons |
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/NCT03829319
GET https://conductscience.org/api/trials/v1/NCT03829319/results?page=2