A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC

Summary

This was a single-arm, open label, multicenter phase II, study of dabrafenib in combination with trametinib in Chinese participants with BRAF V600E mutation positive, stage IV NSCLC (American joint committee on cancer staging 8th edition). Approximately 40 Chinese adults were to be enrolled in this study. Participants were to be treated with dabrafenib in combination with trametinib until disease progression, start of a new anti-neoplastic therapy, unacceptable toxicity, pregnancy, withdrawal of consent, lost to follow-up, physician's decision, death, or if study be terminated by the sponsor. The general study design was discussed and agreed with China National Medical Products Administration and was based on a similar design used in the global pivotal phase II study (Study 113928 / NCT01336634).

Timeline

Start

2020-08-19

Primary completion

2024-11-07

Completion

2024-11-07

Publications

• Results Fan Y, Zhou J, Zhao Y, Yu Y, Yang N, Li J, Wang J, Zhao J, Wang Z, Chen J, Zhu T, Li H, Passos VQ, Bury-Maynard D, Zhang L. Efficacy, safety, and quality of life of dabrafenib plus trametinib treatment in Chinese patients with BRAF V600E mutation-positive metastatic non-small cell lung cancer. Transl Lung Cancer Res. 2024 Dec 31;13(12):3382-3391. doi: 10.21037/tlcr-24-494. Epub 2024 Dec 27.

Drugs

Indications