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Trial 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).

Acronym:

LEAP-008

ACTRN/NCT /ethics:

NCT03976375

Scientific title:

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)

Sponsor / Cooperative group:

Merck Sharp & Dohme Corp.

Trial & Patient Characteristics

Cancer TypeLung & mesothelioma
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream -
Cancer StageMetastatic or Widespread
Anticipated Start Date2019-06-26
Anticipated End Date2026-02-23

Participating Hospitals

HospitalCalvary Central Districts Hospital
Clinical Trial CoordinatorJulie Rowe
Emailjulie.rowe@calvarycare.org.au
Phone08 8239 9536
Principal InvestigatorDr Rohit Joshi
Recruitment StatusRecruiting