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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

NCT03976375•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous Non-Small Cell Lung Cancer (NSCLC) -Stage IV: M1a, M1b, M1c.
•Has progressive disease (PD) on treatment with one prior anti-programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
•* Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment
•Has PD during/after platinum doublet chemotherapy for metastatic disease.
•Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\], and absence of ALK and ROS1 gene rearrangements OR presence of a K-ras mutation).
•Has submitted pre-study imaging that confirmed evidence of PD following initiation of an anti-PD-1/PD-L1 inhibitor.
•Has at least 1 measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment.
•Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample (defined as: from initial diagnosis of NSCLC and prior to receiving immunotherapy \[antiPD-1/PD-L1\], from the primary lesion or a metastatic lesion).
•Has provided prior to allocation tissue from a newly obtained formalin-fixed sample from a new biopsy (defined as: after completion of immunotherapy \[anti-PD-1/PD-L1\] and before receiving a randomization number), of a tumor lesion not previously irradiated.
•Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention but before randomization.
+6 more criteria

Exclusion Criteria

•Has received docetaxel as monotherapy or in combination with other therapies.
•Has received lenvatinib as monotherapy or in combination with an anti-PD-1/PD-L1 mAb.
•Has received: 1) radiotherapy within 2 weeks before the first dose of study treatment; or 2) lung radiation therapy \>30 Gy within 6 months before the first dose of study treatment.
•Has received a live vaccine within 30 days before the first dose of study treatment.
•Has clinically significant hemoptysis or tumor bleeding within 2 weeks before the first dose of study treatment.
•Has radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel.
•Has clinically significant cardiovascular impairment within 12 months of the first dose of study treatment.
•Has a history of a gastrointestinal condition or procedure that may affect oral absorption of study treatment.
•Has a pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
•Is currently participating in a clinical trial and receiving study therapy or participated in a study of an investigational agent within 4 weeks of the first dose of study treatment.
+14 more criteria

Locations (143)

Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604)

Bakersfield, California, United States

Cancer Specialists of North Florida - Fleming Island ( Site 1675)

Fleming Island, Florida, United States

Mid-Florida Cancer Centers ( Site 1611)

Orange City, Florida, United States

University of Kentucky School of Medicine & Hospitals ( Site 1621)

Lexington, Kentucky, United States

Hematology Oncology Clinic ( Site 1680)

Baton Rouge, Louisiana, United States

Harry & Jeanette Weinberg Cancer Institute ( Site 1626)

Baltimore, Maryland, United States

Medstar Good Samaritan Hospital ( Site 1625)

Baltimore, Maryland, United States

Massachusetts General Hospital ( Site 1622)

Boston, Massachusetts, United States

MGH - North Shore Cancer Center ( Site 1668)

Danvers, Massachusetts, United States

The Mass General Cancer Center at Newton-Wellesley ( Site 1692)

Newton, Massachusetts, United States

Key Dates

Start Date

June 26, 2019

Primary Completion Date

August 11, 2023

Completion Date

August 22, 2024

Last Updated

August 15, 2025

Enrollment

422

ACTUAL participants

Conditions

Metastatic Non-Small Cell Lung Cancer

Interventions

Pembrolizumab

BIOLOGICAL

Lenvatinib

DRUG

Docetaxel

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers

Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer

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A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension