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)

  • STATUS
    Recruiting
  • End date
    Feb 23, 2026
  • participants needed
    405
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 24 September 2021
ct scan
cancer
monoclonal antibodies
measurable disease
metastasis
progressive disease
pembrolizumab
biomarker analysis
pd-l1
docetaxel
mk-3475

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).

Details
Condition Metastatic Non Small Cell Lung Cancer
Treatment docetaxel, Pembrolizumab, Lenvatinib
Clinical Study IdentifierNCT03976375
SponsorMerck Sharp & Dohme Corp.
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c)
Has PD on treatment with one prior anti-PD-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
Has submitted pre-study imaging that confirmed evidence of PD following initiation of an anti-PD-1/PD-L1 inhibitor
Has a K-ras mutation
Has at least 1 measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) per 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
Has a life expectancy of at least 3 months
Male participants receiving pembrolizumab lenvatinib or lenvatinib must agree to refrain from donating sperm, and either 1) be abstinent from heterosexual intercourse; or 2) follow contraceptive guidance during the treatment period or 7 days after the last dose of lenvatinib. Male participants receiving docetaxel agree to adhere to the same conditions during the treatment period and for 180 days after the last dose of study treatment
Female participants must not be pregnant, not be breastfeeding, and not be a woman of child-bearing potential (WOCBP). If a WOCBP, agrees to not donate eggs and either use contraception, or be abstinent from heterosexual intercourse during the treatment period and for 120 days after the last dose of pembrolizumab or 30 days after the last dose of lenvatinib, whichever occurs last. If a WOCBP receiving docetaxel, agrees to adhere to the same conditions during the treatment period and for 180 days after the last dose of study treatment
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
If participant received major surgery or radiation therapy of >30 Gy, they have recovered from the toxicity and/or complications from the intervention
Has adequate organ function

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
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment
Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy
Has known active central nervous system metastases and/or carcinomatous meningitis
Has severe hypersensitivity to pembrolizumab and/or any of its excipients
Has a sensitivity to any of the excipients contained in lenvatinib and/or docetaxel
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of hepatitis B reactive or known active hepatitis C virus infection
Has active tuberculosis
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 120 days after the last dose of pembrolizumab or lenvatinib, or 180 days after the last dose of docetaxel
Has had an allogeneic tissue/solid organ transplant
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