A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have received one or two prior lines of systemic therapy for advanced/metastatic disease as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
cMET GCN ≥ 6 cMET GCN ≥ 4 and \< 6 cMET mutations
ORR based on Central Radiology review/assessment (BIRC)
Proportion of patients with a best overall response defined as complete response (CR) or partial response (PR) by Blinded Independent Review Committee (BIRC) assessment per RECIST 1.1
Time frame: at least 18 weeks
Duration of Response (DOR) by BIRC - Key Secondary
Calculated as the time from the date of the first documented CR or PR by Blinded Independent Review Committee (BIRC) per RECIST 1.1 to the first documented progression or death due to any cause for patients with PR or CR.
Time frame: at least 18 weeks
ORR by Investigator
ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 by investigator assessment
Time frame: at least 18 weeks
Duration of Response (DOR) by investigator
DOR per RECIST 1.1 by investigator assessment
Time frame: at least 18 weeks
Time to Response (TTR) by BIRC
TTR per RECIST 1.1 by BIRC assessment
Time frame: at least 18 weeks
Time to Response (TTR) by investigator
TTR per RECIST 1.1 by investigator assessment
Time frame: at least 18 weeks
Disease Control Rate (DCR) by BIRC
DCR per RECIST 1.1 by BIRC assessment
Time frame: at least 18 weeks
Disease Control Rate (DCR) by investigator
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DCR per RECIST 1.1 by investigator assessment
Time frame: at least 18 weeks
Progression-free Survival (PFS) by BIRC
PFS per RECIST 1.1 by BIRC assessment
Time frame: at least 18 weeks
Progression-free Survival (PFS) by investigator
PFS per RECIST 1.1 by investigator assessment
Time frame: at least 18 weeks
Overall Survival (OS)
OS, defined as time from first dose of INC280 to death due to any cause
Time frame: at least 18 weeks
Cmax profile of INC280
Pharmacokinetics of INC280
Time frame: 6 weeks
Cmax profile of INC280 metabolite CMN288
Pharmacokinetics of INC280 metabolite CMN288
Time frame: 6 weeks
Cmin profile of INC280
Pharmacokinetics of INC280
Time frame: 6 weeks
Cmin profile of INC280 metabolite CMN288
Pharmacokinetics of INC280 metabolite CMN288
Time frame: 6 weeks
Plasma concentration-time profiles of INC280
Pharmacokinetics of INC280
Time frame: 6 weeks
Plasma concentration-time profiles of INC280 metabolite CMN288
Pharmacokinetics of INC280 metabolite CMN288
Time frame: 6 weeks