A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment

Phase 2 Completed 161 enrolled Novartis Pharmaceuticals

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2012-04-05
Primary completion: 2016-06-10
Completion: 2020-05-27

Publications

Wu YL, Zhang L, Kim DW, Liu X, Lee DH, Yang JC, Ahn MJ, Vansteenkiste JF, Su WC, Felip E, Chia V, Glaser S, Pultar P, Zhao S, Peng B, Akimov M, Tan DSW. Phase Ib/II Study of Capmatinib (INC280) Plus Gefitinib After Failure of Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy in Patients With EGFR-Mutated, MET Factor-Dysregulated Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Nov 1;36(31):3101-3109. doi: 10.1200/JCO.2018.77.7326. Epub 2018 Aug 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capmatinib	Small molecule	100 mg	Oral
Subject	Capmatinib	Small molecule	200 mg	Oral
Subject	Capmatinib	Small molecule	400 mg	Oral
Subject	Capmatinib	Small molecule	600 mg	Oral
Subject	Capmatinib	Small molecule	800 mg	Oral
Background	Gefitinib	Small molecule	250 mg	—

A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment

Summary

Timeline

Publications

Drugs

Indications