Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer

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 GCN < 4, or

- Cohort 4: Pre-treated patients with cMET mutations regardless of cMET GCN,
or

- Cohort 5: Treatment-naïve patients with cMET dysregulation, or

- Cohort 6: Pre-treated patients with either cMET GCN ≥ 10 without cMET
mutations or cMET mutations regardless of cMET GCN, or

- Cohort 7: Treatment-naïve patients with cMET mutations regardless of cMET
GCN

- To be eligible for Cohorts 1-4, patients must have failed one or two prior lines of
systemic therapy for advanced/metastatic disease

- To be eligible for Cohort 6, patients must have failed one prior line of systemic
therapy for advanced/metastatic disease

- To be eligible for Cohort 5 and Cohort 7, patients must not have received any 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 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

- Applicable to Cohorts 1-4 and Cohort 6 only: 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

- Presence or history of interstitial lung disease or interstitial pneumonitis,
including clinically significant radiation pneumonitis

Other protocol-defined exclusion criteria may apply