Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

Summary

This is a phase I/II study of ceritinib and trametinib in Stage IIIB or IV anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC). The Phase I portion will investigate the safety and tolerability of the combination of ceritinib and trametinib in ALK or ROS-1 rearranged NSCLC. The Phase II portion will investigate the clinical efficiency of the combination of ceritinib and trametinib in 3 single arm cohorts: ALKi (ALK inhibitor) naïve patients; post-crizotinib progressed disease (PD) patients; and PD second line ALK tyrosine kinase inhibitor (TKI) patients.

Timeline

Start

2017-09-09

Primary completion

2022-04-30

Completion

2022-04-30

Publications

• Lara MS, Gubens MA, Bacaltos B, Daran L, Lim SL, Li T, Gandara DR, Bivona TG, Riess JW, Blakely CM. Phase 1 Study of Ceritinib Combined With Trametinib in Patients With Advanced ALK- or ROS1-Positive NSCLC. JTO Clin Res Rep. 2022 Nov 21;3(12):100436. doi: 10.1016/j.jtocrr.2022.100436. eCollection 2022 Dec.

Drugs

Indications