Company Decision

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.

Inclusion Criteria:

• Stage IIIB or IV NSCLC (any histology) at the time of study entry

• Histologically or cytologically confirmed diagnosis of NSCLC that is:

  1. EGFR wt as per patient standard of care by a validated test

  2. AND ALK-negative rearrangement as part of the patient standard of care by a validated test

  3. AND (by central assessment) either:

     • Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or
     • Cohort 2: Pre-treated patients with cMET GCN ≥4 and < 6, or
     • Cohort 3: Pre-treated patients with cMET mutations regardless of cMET GCN, or

• Patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease

• At least one measurable lesion as defined by RECIST 1.1

• 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.

• Patients must have adequate organ function

• ECOG performance status (PS) of 0 or 1

Details and other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Prior treatment with crizotinib, or any other cMET or HGF inhibitor

• Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations

• Patients with characterized ALK-positive rearrangement

• Clinically significant, uncontrolled heart diseases.

• 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 and moderate inhibitors of CYP3A4
  • Strong inducers of CYP3A4

• Impairment of GI function or GI disease that may significantly alter the absorption of INC280

• Patients receiving treatment with any enzyme-inducing anticonvulsant

• Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose

• Pregnant or nursing women

• Women of child-bearing potential, unless they are using highly effective methods of contraception

• Sexually active males unless they use a condom during intercourse

Other protocol-defined exclusion criteria may apply

Planned Shared Data Description: Copy and paste this Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com