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)
Public ClinicalTrials.gov record NCT03829319. 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, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)
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 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. The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.
Study identification
- NCT ID
- NCT03829319
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 761 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Carboplatin Drug
- Cisplatin Drug
- Pemetrexed Drug
- Lenvatinib Drug
- Placebo matching 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 25, 2019 (Actual)
- Primary completion
- Aug 11, 2023 (Actual)
- Completion
- Aug 30, 2024 (Actual)
- Last update posted
- Feb 5, 2026
2019 – 2024
United States locations
- U.S. sites
- 17
- U.S. states
- 15
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| El Camino Hospital Cancer Center ( Site 0529) | Mountain View | California | 94040 | — |
| Yale University ( Site 0519) | New Haven | Connecticut | 06520-8028 | — |
| Holy Cross Hospital ( Site 0512) | Fort Lauderdale | Florida | 33308 | — |
| Mercy Health-Paducah Medical Oncology and Hematology ( Site 0570) | Paducah | Kentucky | 42003 | — |
| Henry Ford Health System ( Site 0563) | Detroit | Michigan | 48202 | — |
| Saint Lukes Cancer Institute ( Site 0541) | Kansas City | Missouri | 64111 | — |
| Broome Oncology, LLC ( Site 0562) | Johnson City | New York | 13790 | — |
| Sanford Health Roger Maris Cancer Center ( Site 0533) | Fargo | North Dakota | 58122 | — |
| Stephenson Cancer Center ( Site 0504) | Oklahoma City | Oklahoma | 73104 | — |
| Good Samaritan Hospital Corvallis ( Site 0521) | Corvallis | Oregon | 97330 | — |
| Thomas Jefferson University Hospital ( Site 0548) | Philadelphia | Pennsylvania | 19107 | — |
| Abington Hospital - Asplundh Cancer Center ( Site 0575) | Willow Grove | Pennsylvania | 19090 | — |
| West Cancer Center - East Campus ( Site 0544) | Germantown | Tennessee | 38138 | — |
| Parkland Health & Hospital System ( Site 0576) | Dallas | Texas | 75235 | — |
| UT Southwestern Medical Center ( Site 0558) | Dallas | Texas | 75390 | — |
| Utah Cancer Specialists ( Site 0523) | Salt Lake City | Utah | 84106 | — |
| West Virginia University ( Site 0526) | Morgantown | West Virginia | 26506 | — |
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 141 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03829319, 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 5, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03829319 live on ClinicalTrials.gov.