Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC)

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