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  • LEAP-008

    Acronym: 

    LEAP-008

    ACTRN/NCT /ethics: 

    NCT03976375

    Scientific title: 

    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

    Summary of trial and patient characteristics

    Cancer Type Lung & mesothelioma
    Trial Type Treatment
    Phase Tumour Stream Lung Cancer
    Age Range 18 years and older Cancer Stage Metastatic or Widespread
    Sex Both Anticipated Start Date 2019-06-26
    Molecular Target Anticipated End Date 2026-02-23
    Cancer Type Lung & mesothelioma
    Trial Type Treatment
    Phase
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Lung Cancer
    Cancer Stage Metastatic or Widespread
    Anticipated Start Date 2019-06-26
    Anticipated End Date 2026-02-23

    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 an 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).

    Lay Summary

    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

    Sponsor / Cooperative group

    Merck Sharp & Dohme Corp.

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Calvary Central Districts Hospital Julie Rowe julie.rowe@calvarycare.org.au 08 8239 9536 Not Yet Recruiting