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Clinical Trials/EUCTR2018-003791-12-GB
EUCTR2018-003791-12-GBActive, not recruitingPhase 1

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 (anti-PD-1/PD-L1 inhibitor) (LEAP-008) - Pembrolizumab + Lenvatinib verses Docetaxel in 2L+ NSCLC (LEAP-008)

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites391 target enrollmentStarted: July 6, 2020Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
391
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Have a histologically or cytologically confirmed diagnosis of
  • •metastatic squamous or nonsquamous NSCLC
  • •2. Have PD on treatment with one prior anti-PD-1/PD-L1 mAb
  • •administered either as monotherapy or in combination with other
  • •checkpoint inhibitors or other therapies. Anti- PD-1/PD-L1 treatment
  • •progression is defined by meeting ALL of the following criteria:
  • •Treatment with at least 2 doses of an anti-PD-1/PD-L1 mAb
  • •PD after an anti-PD-1/PD-L1 mAb as defined by RECIST v1.1. Evidence
  • •of PD is defined as:
  • •- imaging prior to anti-PD-1/PD-L1 treatment or image showing nadir
  • •during anti-PD-1/PD-L1 treatment; AND
  • •- imaging to determine that radiographic progression has occurred per
  • •RECIST 1.1 within 12 weeks (84 days) from the last dose of an anti-PD-
  • •1/PD-L1 mAb.
  • •3. Have PD during/after platinum doublet chemotherapy for metastatic
  • •4. Have confirmation that EGFR-, ALK-, or ROS1-directed therapy is not
  • •indicated as primary therapy (documentation of absence of tumoractivating
  • •EGFR mutations [eg, DEL19 or L858R], and absence of ALK
  • •and ROS1 gene rearrangements OR presence of a K-ras mutation)
  • •5. Have submitted prestudy imaging that confirmed evidence of PD
  • •based on investigator review of at least 2 images per RECIST 1.1,
  • •following initiation of an anti-PD-1/PD-L1 mAb
  • •6. Have measurable disease based on RECIST 1.1 as determined by the
  • •local site assessment.
  • •Have at least 1 measurable lesion by CT or MRI per RECIST 1.1
  • •7. Have 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)
  • •8. Have provided prior to randomization 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
  • •9. Be =18 years of age on the day of signing the ICF
  • •10. Have ECOG performance status of 0 or 1 within 7 days before the
  • •first dose of study intervention but before randomization
  • •11. Have a life expectancy of at least 3 months
  • •12. Male participants receiving pembrolizumab ± lenvatinib or lenvatinib
  • •are eligible to participate if they agree to the following during the
  • •intervention period or 30 days after the last dose of lenvatinib:
  • •Male participants randomized to docetaxel are eligible to participate if
  • •they agree to the following during the intervention period and for at
  • •least 180 days after the last dose of docetaxel:
  • •Refrain from donating sperm
  • •PLUS either:
  • •Be abstinent from heterosexual intercourse as their preferred and
  • •usual lifestyle (abstinent on a long-term and persistent basis) and agree
  • •to remain abstinent.
  • •Must agree to use contraception unless confirmed to be azoospermic
  • •(vasectomized or secondary to medical cause)
  • +10 more not shown

Exclusion Criteria

  • •1. Has received docetaxel as monotherapy or in combination with other
  • •2. Has received lenvatinib as monotherapy or in combination with an
  • •anti-PD-1/PD-L1 mAb
  • •3. Has received radiotherapy within 2 weeks before the first dose of
  • •study intervention or has received lung radiation therapy >30 Gy within
  • •6 months before the first dose of study intervention
  • •4. Has received a live vaccine within 30 days before the first dose of
  • •study intervention
  • •5. Has clinically significant hemoptysis (at least 0.5 teaspoon of bright
  • •red blood) or tumor bleeding within 2 weeks before the first dose of
  • •study intervention
  • •6. Has radiographic evidence of intratumoral cavitation, encasement, or
  • •invasion of a major blood vessel. Additionally, the degree of proximity to
  • •major blood vessels should be considered for exclusion because of the
  • •potential risk of severe hemorrhage associated with tumor
  • •shrinkage/necrosis after lenvatinib therapy. In the chest, major blood
  • •vessels include the main pulmonary artery, the left and right pulmonary
  • •arteries, the 4 major pulmonary veins, the superior or inferior vena cava,
  • •and the aorta.
  • •7. Has clinically significant cardiovascular impairment within 12 months
  • •of the first dose of study intervention, such as history of congestive
  • •heart failure greater than New York Heart Association Class II, unstable
  • •angina, myocardial infarction or cerebrovascular accident/transient
  • •ischemic attack (TIA)/stroke, cardiac revascularization, or cardiac
  • •arrhythmia associated with hemodynamic instability
  • •8. Has a history of a gastrointestinal condition or procedure that, in the
  • •opinion of the investigator, may affect oral study intervention absorption
  • •9. Has a pre-existing =Grade 3 gastrointestinal or non-gastrointestinal
  • •10. Is a WOCBP who has a positive urine pregnancy test within 24 hours
  • •before randomization
  • •11. 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 intervention
  • •12. Has a diagnosis of immunodeficiency or is receiving chronic systemic
  • •steroid therapy (exceeding 10 mg of prednisone or equivalent daily) or
  • •any other form of immunosuppressive therapy within 7 days before the
  • •first dose of study intervention
  • •13. 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
  • •14. Has known active central nervous system metastases and/or
  • •carcinomatous meningitis
  • •15. Has severe hypersensitivity (Grade =3) to pembrolizumab and/or
  • •any of its excipients
  • •16. Has a sensitivity to any of the excipients contained in lenvatinib
  • •17. Has a sensitivity to any of the excipients contained in docetaxel
  • •18. Has an active autoimmune disease that has required systemic
  • •treatment in the past 2 years (ie, with use of disease-modifying agents,
  • •corticosteroids, or immunosuppressive drugs)
  • •19. Has a history of (noninfectious) pneumonitis that required systemic
  • +8 more not shown

Investigators

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