lung cancer
Conditions
Interventions
Treatment with INC280.
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Female and male patients >= 18 years of age. • Stage IIIB or IV NSCLC. • Histologically or cytologically confirmed diagnosis of NSCLC (see protocol page 42 for details): • EGFR wild-type. • ALK-negative rearrangement. • Pre-treated Patients with cMET GCN>=6 and =10 (cohort 1b), GCN>=4 and = 10 (cohort 5a), cMET mutations (cohort 5b), Pre-treated patients (1 treatment line) with either cMET GCN >= 10 without cMET mutations or cMET mutations regardless of cMET GCN (cohort 6 = expansion group). Treatment naive patients with cMET mutations, regardless of cMET GCN (Cohort 7 = expansion group) • For cohort 1-4 patients must have received one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB or IV NSCLC). For cohort 5 patients must have received no prior lines of systemic therapy for advanced/metastatic disease (stage IIIB or IV NSCLC). See protocol page 42 for details. • Measurable disease. See protocol page 42 for details. • ECOG performance status 0-1.
Exclusion criteria
Exclusion criteria: • Prior treatment with crizotinib, or any other cMET or HGF inhibitor. • Characterized EGFR mutations that predict sensitivity to EGFR therapy. • Characterized ALK-positive rearrangement. • Symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry. • Clinically significant, uncontrolled heart diseases. See protocol page 44 for details. • Thoracic radiotherapy to lung fields
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR by blinded independent review committee. | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR, ORR and DOR by investigator, TTR, DCTR, PFS, OS, adverse events, PK parameters. | — |
Countries
Netherlands
Outcome results
None listed