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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

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).

Key facts

Study ID: NCT03829332
Run by: Merck Sharp & Dohme LLC
People needed: 623
Starts: 2019-03-13
Expected to finish: 2024-04-24
Last updated by the study team: 2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
Has Stage IV NSCLC (American Joint Committee on Cancer [AJCC 8th edition])
Has measurable disease based on RECIST 1.1
Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression in ≥1% of tumor cells (Tumor Proportion Score [TPS] ≥1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central laboratory
Has a life expectancy of ≥3 months
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study treatment but before randomization
Male participants must agree to the following during the treatment period and for ≥7 days after the last dose of lenvatinib/matching placebo: 1) Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR 2) Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
Female participants are eligible to participate if not pregnant or breastfeeding, and ≥1 of the following applies: 1) Is not a woman of child-bearing potential (WOCBP), OR 2) Is a WOCBP and is using a highly effective contraceptive method that has a low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and for ≥120 days post pembrolizumab or ≥30 days post lenvatinib/matching placebo, whichever occurs last
Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week before randomization
Has adequate organ function

You may not qualify if…

Has known untreated central nervous system metastases and/or carcinomatous meningitis
Has active hemoptysis (at least 0.5 teaspoon of bright red blood) within 2 weeks prior to the first dose of study intervention
Has radiographic evidence of intratumoral cavitations, encasement, or invasion of a major blood vessel
Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for ≥3 years since initiation of that therapy. (Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.)
Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed
Has had an allogeneic tissue/solid organ transplant
Has a known history of human immunodeficiency virus (HIV) infection
Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
Has a known history of hepatitis B or known active hepatitis C virus infection
Has a history of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral study drug absorption.
Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as a history of congestive heart failure greater than New York Heart Association Class II, unstable angina, myocardial infarction, cerebrovascular accident/stroke, or cardiac arrhythmia associated with hemodynamic instability
Has not recovered adequately from any toxicity and/or complications from major surgery before starting study treatment
Has a known history of active tuberculosis (TB)
Has an active infection requiring systemic therapy
Has previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity or intolerance to any component of lenvatinib or pembrolizumab
Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]) or has received lenvatinib as monotherapy or in combination with anti- programmed cell death protein (anti-PD-1) agents
Has received radiotherapy within 14 days before the first dose of study treatment or received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose of study treatment. (Note: Participants must have recovered from all radiation-related toxicities to ≤Grade 1, not require corticosteroids, and not have had radiation pneumonitis.)
Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days before the first dose of study treatment
Is receiving systemic steroid therapy (doses >10 mg daily of prednisone equivalent) within 7 days before the first dose of study treatment
Has received a live or attenuated vaccine within 30 days before the first dose of study treatment
Has had major surgery within 3 weeks prior to first dose of study treatment
Has pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula

Where it is running

Ironwood Cancer & Research Centers ( Site 0541) — Chandler, Arizona, United States
CBCC Global Research, Inc. ( Site 0532) — Bakersfield, California, United States
Scripps Cancer Center ( Site 0521) — La Jolla, California, United States
Florida Hospital ( Site 0526) — Orlando, Florida, United States
Northwest Georgia Oncology Centers PC ( Site 0518) — Marietta, Georgia, United States
Illinois Cancer Care, PC ( Site 0557) — Peoria, Illinois, United States
Parkview Cancer Center ( Site 0542) — Fort Wayne, Indiana, United States
University of Kentucky School of Medicine & Hospitals ( Site 0517) — Lexington, Kentucky, United States
Anne Arundel Medical Center Oncology and Hematology ( Site 0514) — Annapolis, Maryland, United States
Munson Medical Center ( Site 0512) — Traverse City, Michigan, United States
Park Nicollet Frauenshuh Cancer Center ( Site 0554) — Saint Louis Park, Minnesota, United States
University of Missouri Health Care ( Site 0555) — Columbia, Missouri, United States
Billings Clinic Cancer Center ( Site 0508) — Billings, Montana, United States
Cone Health Cancer Center at Alamance Regional ( Site 0527) — Greensboro, North Carolina, United States
Genesis Cancer Care Center ( Site 0559) — Zanesville, Ohio, United States
Oregon Health Sciences University ( Site 0544) — Portland, Oregon, United States
Central Texas Veterans Healthcare System ( Site 0533) — Temple, Texas, United States
Orange Health Services ( Site 0002) — Orange, New South Wales, Australia
Wollongong Private Hospital ( Site 0005) — Wollongong, New South Wales, Australia
The Prince Charles Hospital ( Site 0011) — Chermside, Queensland, Australia
Ballarat Oncology and Haematology Services ( Site 0008) — Wendouree, Victoria, Australia
St John of God Murdoch Medical Clinic ( Site 0001) — Perth, Western Australia, Australia
Cross Cancer Institute ( Site 0400) — Edmonton, Alberta, Canada
Lions Gate Hospital ( Site 0407) — North Vancouver, British Columbia, Canada
Alaska Clinical Research Center ( Site 0511) — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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