Phase Ib study population

Approximately 15 patients with locally advanced or metastatic NSCLC (Stage IIIb, IIIc or IV). All patients should carry at least one of the following MET alterations (confirmed by local or central laboratory):

• Patients with METex14 skipping mutation who had previously responded to and later progressed on another MET inhibitor
• Patients with MET amplification (FISH GCN 5 or MET/CEP7 ratio 2)
• Patients with MET over-expression (IHC3+) Phase II - Safety Run-in Population (US only) A minimum of 6 patients who meeting the eligibility for either Phase Ib or Phase II.

Phase II study population (globally) Approximately 90 patients with locally advanced or metastatic NSCLC (Stage IIIb, IIIc or IV) harboring METex14 skipping mutation that have been pre-screened by local or Sponsor-designated central laboratory, who are either systemic treatment nave (patients should be chemotherapy intolerance or not eligible for chemotherapy or patients refusing of chemotherapy after well-informed) or no more than 2 prior systemic therapies and have not had prior MET inhibitor for the advanced NSCLC. It is planned that approximately 30% of the enrolled patients are systemic treatment nave for the advanced disease.

After approximately 90 patients have been enrolled, if the proportion of patients at sites in Japan is < 10% of the total population, enrollment may continue in Japan until the proportion is 10%.