Conditions: Non-small Cell Lung Cancer
Keywords: EGFR c-MET Lung cancer Gefitinib Erlotinib Non-small cell lung cancer (NSCLC) lung adenocarcinoma large-cell lung carcinoma
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 161
Healthy volunteers: no

Brief summary:
This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.

Detailed description:
The Phase Ib dose escalation part was aimed at the determination of the MTD/RP2D of capmatinib in combination with 250 mg gefitinib in patients with NSCLC patients with epidermal growth factor receptor (EGFR) mutation and cMET dysregulation and showing disease progression following EGFR tyrosine-kinase inhibitor (EGFR TKI) therapy. Dose escalation started with a dose of 100 mg/day to a maximum of 1200 mg/day, as capsule or tablet formulation. Successive cohorts of patients were to receive increasing doses of capmatinib in combination with a 250 mg once daily (qd) dose of gefitinib until the MTD/RP2D of capmatinib had been determined. The Phase II dose expansion part consisted of 400 mg capmatinib twice daily (bid), as either capsules or tablets, in combination with 250 mg gefitinib.

Arms:
arm 1: cap=capsule; QD=once daily arm 2: cap=capsule; QD=once daily arm 3: cap=capsule; QD=once daily arm 4: cap=capsule; QD=once daily arm 5: cap=capsule; BID=twice daily arm 6: cap=capsule; BID=twice daily arm 7: cap=capsule; BID=twice daily arm 8: tab=tablet; BID=twice daily arm 9: tab=tablet; BID=twice daily arm 10: cap=capsule; BID=twice daily arm 11: tab=tablet; BID=twice daily

Interventions: intervention 1: INC280 intervention 2: Gefitinib
Intervention descriptions: intervention 1: During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose. intervention 2: Gefitinib 250 mg taken once daily

Protocol document: