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

Summary

Participation Requirements

Description

This is a single arm, open label, multicenter phase II study evaluating the efficacy and safety of dabrafenib in combination with trametinib in Chinese subjects with BRAF V600E mutation positive AJCC v8 stage IV Non-Small Cell Lung Cancer. Subjects with stage IV BRAF V600E mutant Non-Small Cell Lung...

This is a single arm, open label, multicenter phase II study evaluating the efficacy and safety of dabrafenib in combination with trametinib in Chinese subjects with BRAF V600E mutation positive AJCC v8 stage IV Non-Small Cell Lung Cancer. Subjects with stage IV BRAF V600E mutant Non-Small Cell Lung Cancer confirmed by local qualified assay (approved by China health authorities) will be enrolled in this study. Central confirmation testing for BRAF V600E will be performed. This study will enroll subjects: who have not received any prior systemic anti-cancer therapy for metastatic disease (i.e. dabrafenib/trametinib will be the 1st line treatment for metastatic disease) who have relapsed or progressed on at least one prior platinum based chemotherapy prior to enrollment but cannot have received more than 3 prior systemic therapies for metastatic disease (i.e. dabrafenib/trametinib will be no less than second line treatment for metastatic disease). All subjects must not have been previously exposed to a BRAF or MEK inhibitor. Subjects will receive the recommended dose of both drugs (dabrafenib 150 mg twice daily and trametinib 2 mg once daily). The primary endpoint for the study is Overall Response Rate, as determined by central independent review, using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Approximately 20 Chinese patients over 18 years old will be enrolled in this study and will receive dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) combination therapy until disease progression by RECIST 1.1, unacceptable toxicity, start of a new antineoplastic therapy, pregnancy, withdrawal of consent, lost to follow-up, physician's decision, death, or if study is terminated by the sponsor. Doses of study treatment may be modified and/or interrupted for management of toxicities associated with study treatment. Treatment beyond disease progression per RECIST is allowed if protocol specific criteria are met. The tumor assessments will be performed every 6 weeks until Week 36, and every 12 weeks thereafter until disease progression, death, lost of follow-up, or withdrawal of consent. Survival and new anti-cancer therapy follow-up will continue until study completion.

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