Study of efficacy and safety of capmatinib in combination with spartalizumab in naive patients with EGFR wild type (wt), ALK rearrangement negative advanced NSCLC, harboring MET exon 14 skipping mutations.
- Conditions
- on small cell lung cancer(NSCLC)
- Registration Number
- JPRN-jRCT2080225343
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 270
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Run-in part:<br>- Overall Response Rate by Investigator assessment as per RECIST 1.1<br>Run-in part To evaluate the anti-tumor activity of capmatinib in combination with spartalizumab<br>Randomized part:<br>- Progression Free survival (PFS) by BIRC as per RECIST 1.1<br>Randomized part To compare the efficacy of capmatinib in combination with spartalizumab versus capmatinib plus placebo
- Secondary Outcome Measures
Name Time Method