Study of oral cMET inhibitor INC280 in patients with EGFR wild-type (wt), advanced non-small cell lung cancer (NSCLC)

A phase II, multicenter study of oral cMET inhibitor INC280 in adult patients with EGFR wild-type (wt), advanced non-small cell lung cancer (NSCLC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222990

Enrollment

Registered

2015-10-20

Start date

2015-08-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

investigational material(s) Generic name etc : INN of investigational material : Capmatinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational materi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
efficacy ORR	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics DOR,TTR,DCR,PFS,OS,Safety,PK	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026