A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.

Safety Set: All patients in phase Ib who received at least one full or partial dose of INC280 or gefitinib.

Overall response rate is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), as per RECIST 1.1 (Overall Response (OR) = CR + PR).

Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Full analysis set: all patients in phase II who receive at least one full or partial dose of INC280 or gefitinib.

Adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Safety Set: All patients in phase Ib and II who received at least one full or partial dose of INC280 or gefitinib and and had at least one valid postbaseline safety assessment.

Serious adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Safety Set: All patients in phase Ib and II who received at least one full or partial dose of INC280 or gefitinib and and had at least one valid postbaseline safety assessment.

Number of patients with dose reductions of INC280 by dose level as a measure of tolerability.

Safety Set: All patients in phase Ib and II who received at least one full or partial dose of INC280 or gefitinib.

Number of patients with dose interruptions of gefitinib by dose level as a measure of tolerability

Safety set: All patients in phase Ib and II who received at least one full or partial dose of INC280 or gefitinib.

Overall survival is defined as the time from the start of treatment date to the date of death, due to any cause

Full analysis set: all patients in phase II who receive at least one full or partial dose of INC280 or gefitinib.

Progression-free survivalis the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.

Full analysis set: all patients in phase II who receive at least one full or partial dose of INC280 or gefitinib

Duration of overall response (DOR) is defined as the time between the date of first documented response (CR or PR) and the date of first documented disease progression or death due to underlying cancer.

Full analysis set subjects in phase II with confirmed complete response (CR) or partial response (PR)

PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.

Area under the plasma concentration-time curve (AUC) from time zero to the end of dosing interval at steady state (tau), where tau=24 hours for once daily dosing and tau=12 hours for twice daily dosing

Pharmacokinetic analysis set: all patients having at least one evaluable PK profile of INC280 and/or gefitinib. Patients were included on the estimation of this PK parameter if a sufficient number of blood samples was available.

PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.

Cmax is the maximum observed plasma concentration of INC280 and gefitinib

Pharmacokinetic analysis set: all patients having at least one evaluable PK profile of INC280 and/or gefitinib. Patients were included on the estimation of this PK parameter if a sufficient number of blood samples was available.

PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.

Tmax is the time to reach maximum plasma concentration of INC280 and gefitinib

Pharmacokinetic analysis set: all patients having at least one evaluable PK profile of INC280 and/or gefitinib. Patients were included on the estimation of this PK parameter if a sufficient number of blood samples was available.

PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.

Apparent systemic plasma clearance rate of INC280 and gefitinib

Pharmacokinetic analysis set: all patients having at least one evaluable PK profile of INC280 and/or gefitinib. Patients were included on the estimation of this PK parameter if a sufficient number of blood samples was available.

PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.

The elimination half-life of INC280 and gefitinib associated with the terminal slope (Lamda_z) of a semi-logarithmic plasma concentration-time curve

Pharmacokinetic analysis set: all patients having at least one evaluable PK profile of INC280 and/or gefitinib. Patients were included on the estimation of this PK parameter if a sufficient number of blood samples was available.

Inhibition of c-MET signaling by pre- and post- treatment immunohistochemistry of p-c-MET

Full analysis set patients in phase Ib with p cMET H score measured. Few tumor samples were available since tumor biopsy was optional for this study.