A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus capmatinib and placebo as first line treatment for locally advanced or metastatic non-small cell lung cancer patients with MET exon 14 skipping mutations

ovartis Pharma. K.K.0 个研究点目标入组 270 人开始时间: 2020年8月25日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting
•- Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement statu
•- Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS >= 50%)
•- ECOG performance status score =< 1
•- Have at least 1 measurable lesion by RECIST 1.1
•- Have adequate organ function

•- Prior treatment with a MET inhibitor or HGF-targeting therapy
•- Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
•- Have untreated symptomatic central nervous system (CNS) metastases
•- Clinically significant, uncontrolled heart diseases
•- Prior palliative radiotherapy for bone lesions =< 2 weeks prior to starting study treatment

发起方

ovartis Pharma. K.K.