Trials / Completed
CompletedNCT03976375
Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)
A Phase 3, Multicenter, Randomized, Open-label Trial to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Docetaxel in Previously Treated Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (LEAP-008)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 422 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | IV infusion of pembrolizumab at 200 mg |
| DRUG | Lenvatinib | Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose. |
| DRUG | Docetaxel | IV infusion of docetaxel at 75 mg/m\^2. |
Timeline
- Start date
- 2019-06-26
- Primary completion
- 2023-08-11
- Completion
- 2024-08-22
- First posted
- 2019-06-06
- Last updated
- 2025-08-15
- Results posted
- 2024-08-22
Locations
143 sites across 18 countries: United States, Argentina, Australia, Canada, Colombia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Portugal, Puerto Rico, Russia, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03976375. Inclusion in this directory is not an endorsement.