Study of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: \- 1. Histologically or cytologically documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration. Note: Subjects who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample. Mixed tumors are not eligible. * 2\. ES-SCLC, stage IV disease by the American Joint Committee on Cancer, 8th Edition criteria (70), \[T any, N any, M1a, M1b, M1c\], or T3-4 due to multiple lung nodules that are too extensive or tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. * 3\. Have at least one lesion that meets criteria for being measurable, as defined by RECIST 1.1. * 4\. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for biomarker assessment. * 5\. Be male or female ≥18 years of age inclusive, on the day of signing informed consent. * 6\