Study of efficacy and safety of capmatinib in combination with pembrolizumab versus pembrolizumab alone in subjects with non-small cell lung cancer with PD-L1>= 50%
- Conditions
- on small cell lung cancer (NSCLC)
- Registration Number
- JPRN-jRCT2080225053
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 96
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
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) based on local investigator assessment as per RECIST 1.1
- Secondary Outcome Measures
Name Time Method - Objective response rate (ORR), Disease control rate (DCR), Time-to-response (TTR), Duration of response (DOR) based on local investigator assessment as per RECIST 1.1<br>- Overall survival (OS)<br>- Incidence of adverse events is defined as number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose interruption, dose reduction and dose discontinuation.<br>- Pharmacokinetic parameters and concentration<br>- Antidrug antibodies (ADA)