A phase II, multicenter, randomized, two-arm study of capmatinib (INC280, an oral MET inhibitor) and spartalizumab (PDR001, a PD-1 inhibitor) combination therapy versus docetaxel in pretreated adult patient with EGFR wild-type, ALK rearrangement negative locally advanced/metastatic non-small cell lung cancer.
- Conditions
- non-small cell lung cancerlung cancer1002765610029107
- Registration Number
- NL-OMON48017
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
* Histologically confirmed locally advanced/metastatic (stage IIIB/IV) per
AJCC/IASLC v.8) NCSCL
* EGFR wild-type, ALK rearrangement negative, NSCLC
* Subject has demonstrated progression following one prior platinum doublet and
one prior PD-(L)1 checkpoint inhibitor (either alone or in combination, the most
recent treatment regimen must have contained a PD-(L)1 checkpoint inhibitor)
* Subjects must be candidates for single agent docetaxel
* Subjects must have at least one lesion evaluable by RECIST 1.1
* Prior treatment with a MET inhibitor or HGF (Hepatocyte growth factor)
targeting
therapy
* Any untreated central nervous system (CNS) lesion
* Use of any live vaccines against infectious diseases within 12 weeks of
initiation
of study treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In the run-in part safety and tolerability data will be assessed when all<br /><br>patients in this phase have at least 24 weeks of follow-up as well as<br /><br>preliminary efficacy. </p><br>
- Secondary Outcome Measures
Name Time Method