A total of 85 subjects will be assigned to study treatment with pembrolizumab + lenvatinib + chemotherapy. Positive tumor programmed cell death-ligand 1 (PD-L1) expression will not be required for enrollment; however, subjects' tumors will be screened for PD-L1 expression.~The primary endpoint for the Part 1 is to determine the safety of the combination. The primary endpoint for Part 2 is to determine the Progression Free survival (PFS) using RECIST 1.1. assessed by investigator.~The sponsor estimates that the trial will require approximately 4 years from the time the first participant signs the informed consent until the last participant's last study-related telephone call or visit (2 years recruiting patients, 1 year of treatment and at least 1 year of follow up)
This is a multicenter, open-label, non-randomized, single arm, 2 parts, phase II clinical trial evaluating the efficacy and safety of pembrolizumab and lenvatinib plus standard of care chemotherapy (with carboplatin and etoposide ) in subjects with histologically confirmed extensive-stage small-cell lung cancer who have not previously received systemic therapy for this malignancy.