CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 422 enrolled
Drug / intervention
Pembrolizumab +2 morebiological
Likely dose
Pembrolizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03976375
NCT03976375Phase 3Completed
CompareCT.gov

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)

Merck Sharp & Dohme LLC·interventional·Posted Jun 6, 2019·Updated Aug 15, 2025

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Lenvatinib, and 1 other intervention for Metastatic Non-Small Cell Lung Cancer. Completed, enrolled 422 participants across 143 sites in 18 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Non-Small Cell Lung Cancer
CountriesArgentina, Australia, Canada, Colombia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Portugal, Puerto Rico, Russia, South Korea, Spain, United Kingdom, United States
CollaboratorsEisai Inc.

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 6, 2019
Enrollment StartJun 26, 2019
Primary CompletionAug 11, 2023
Study CompletionAug 22, 2024
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.1 years ago

Interventions

Pembrolizumabbiological

IV infusion of pembrolizumab at 200 mg

Lenvatinibdrug

Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose.

Docetaxeldrug

IV infusion of docetaxel at 75 mg/m\^2.