Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)
Public ClinicalTrials.gov record NCT03829332. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%. The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).
Study identification
- NCT ID
- NCT03829332
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 623 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Lenvatinib Drug
- Placebo for lenvatinib Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 13, 2019 (Actual)
- Primary completion
- May 19, 2021 (Actual)
- Completion
- Apr 24, 2024 (Actual)
- Last update posted
- Feb 19, 2026
2019 – 2024
United States locations
- U.S. sites
- 18
- U.S. states
- 17
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Clinical Research Center ( Site 0511) | Anchorage | Alaska | 99503 | — |
| Ironwood Cancer & Research Centers ( Site 0541) | Chandler | Arizona | 85224 | — |
| CBCC Global Research, Inc. ( Site 0532) | Bakersfield | California | 93309 | — |
| Scripps Cancer Center ( Site 0521) | La Jolla | California | 92037 | — |
| Florida Hospital ( Site 0526) | Orlando | Florida | 32803 | — |
| Northwest Georgia Oncology Centers PC ( Site 0518) | Marietta | Georgia | 30060 | — |
| Illinois Cancer Care, PC ( Site 0557) | Peoria | Illinois | 61615 | — |
| Parkview Cancer Center ( Site 0542) | Fort Wayne | Indiana | 46845 | — |
| University of Kentucky School of Medicine & Hospitals ( Site 0517) | Lexington | Kentucky | 40536 | — |
| Anne Arundel Medical Center Oncology and Hematology ( Site 0514) | Annapolis | Maryland | 21401 | — |
| Munson Medical Center ( Site 0512) | Traverse City | Michigan | 49684 | — |
| Park Nicollet Frauenshuh Cancer Center ( Site 0554) | Saint Louis Park | Minnesota | 55426 | — |
| University of Missouri Health Care ( Site 0555) | Columbia | Missouri | 65212 | — |
| Billings Clinic Cancer Center ( Site 0508) | Billings | Montana | 59101 | — |
| Cone Health Cancer Center at Alamance Regional ( Site 0527) | Greensboro | North Carolina | 27403 | — |
| Genesis Cancer Care Center ( Site 0559) | Zanesville | Ohio | 43701 | — |
| Oregon Health Sciences University ( Site 0544) | Portland | Oregon | 97239 | — |
| Central Texas Veterans Healthcare System ( Site 0533) | Temple | Texas | 76504 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 144 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03829332, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 19, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03829332 live on ClinicalTrials.gov.