Geometry Duo-1: A Phase (Ph) Ib/Ii, Multicenter Trial Of Oral Cmet Inhibitor Capmatinib (Inc280) +/- Erlotinib Vs Platinum Plus Pemetrexed In Adult Patients (Pts) With Epidermal Growth Factor Receptor (Egfr)-Mutated, Cmet-Amplified, Locally Advanced/Metastatic Non-Small Cell Lung Cancer (Nsclc) With Acquired Resistance To Prior Egfr Tyrosine Kinase Inhibitor (Tki) Therapy.

TPS9109Background: Despite high overall response rates (ORR) to EGFR TKIs, most pts with EGFR-mutated NSCLC develop acquired resistance; secondary activation of cMET as gene amplification, occurs in ~20% of cases. Capmatinib (INC280) is a potent and selective cMET inhibitor. Preliminary clinical activity of INC280 + gefitinib was reported in pts with EGFR-mutated, cMET-amplified, EGFR TKI-resistant NSCLC. Methods: This multicenter, Ph Ib/II study (NCT02468661) will commence with a dose-escalation safety phase of INC280 + erlotinib. This will be followed by a randomized Ph II part, which will study the safety and efficacy of INC280 ± erlotinib compared with platinum + pemetrexed, in pts with EGFR TKI-resistant advanced NSCLC due to cMET amplification (EGFR T790M-negative). cMET gene copy number will be determined by fluorescence in situ hybridization. Eligible pts ( ≥ 18 years of age; ECOG PS 0–1) must have had prior therapy with a 1st/2nd-generation EGFR TKI ( ≥ 1 in Ph Ib: only 1 in Ph II). Pts in Ph II ...