Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer.

Summary

The purpose of this study was to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of nazartinib (EGF816) in combination with capmatinib (INC280) and to estimate the preliminary anti-tumor activity of nazartinib in combination with capmatinib in participants with advanced non-small cell lung cancer (NSCLC) with documented EGFR mutation.

Timeline

Start

2015-01-13

Primary completion

2020-11-10

Completion

2020-11-10

Publications

• Felip E, Metro G, Soo RA, Wolf J, Solomon BJ, Tan DS, Ardizzoni A, Lee DH, Sequist LV, Barlesi F, Ponce-Aix S, Abreu DR, Campelo MRG, Sprauten M, Djentuh LO, Smith N, Jary A, Belli R, Glaser S, Zou M, Cui X, Giovannini M, Yang JC. Capmatinib plus nazartinib in patients with EGFR-mutated non-small cell lung cancer. Eur J Cancer. 2024 Sep;208:114182. doi: 10.1016/j.ejca.2024.114182. Epub 2024 Jun 22.
• Jia Y, Juarez J, Li J, Manuia M, Niederst MJ, Tompkins C, Timple N, Vaillancourt MT, Pferdekamper AC, Lockerman EL, Li C, Anderson J, Costa C, Liao D, Murphy E, DiDonato M, Bursulaya B, Lelais G, Barretina J, McNeill M, Epple R, Marsilje TH, Pathan N, Engelman JA, Michellys PY, McNamara P, Harris J, Bender S, Kasibhatla S. EGF816 Exerts Anticancer Effects in Non-Small Cell Lung Cancer by Irreversibly and Selectively Targeting Primary and Acquired Activating Mutations in the EGF Receptor. Cancer Res. 2016 Mar 15;76(6):1591-602. doi: 10.1158/0008-5472.CAN-15-2581. Epub 2016 Jan 29.

Drugs

Indications