Study of oral cMET inhibitor INC280 in patients with EGFR wild-type (wt), advanced non-small cell lung cancer (NSCLC)
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-jRCT2080222990
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 38
1.Stage IIIB or IV NSCLC (any histology) at the time of study entry
2.EGFR wt as per patient standard of care by a validated test, and ALK-negative rearrangement as part of the patient standard of care by a validated test
3.Patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease, or patients must not have received any systemic therapy for advanced/metastatic disease.
4.At least one measurable lesion as defined by RECIST 1.1
5.Patients must have recovered from all toxicities related to prior anticancer therapies to grade =< 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
6.Patients must have adequate organ function
7.ECOG performance status (PS) of 0 or 1 Details and other protocol-defined inclusion criteria may apply
1.Prior treatment with crizotinib, or any other cMET or HGF inhibitor
2.Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
3.Patients with characterized ALK-positive rearrangement
4.Clinically significant, uncontrolled heart diseases.
5.Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:
Strong inducers of CYP3A4
6.Impairment of GI function or GI disease that may significantly alter the absorption of INC280
7.Patients receiving treatment with any enzyme-inducing anticonvulsant
8.Previous anti-cancer and investigational agents within 4 weeks or =< 5 x half-life of the agent (whichever is longer) before first dose
Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>ORR
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>DOR,TTR,DCR,PFS,OS,Safety,PK