Non-Small-Cell Lung Cancer Clinical Trial
Official title:
A Phase II, Multi-center, Single Arm, Open Label Study to Assess Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer
This is an open-label, multicenter, non-randomized, single arm, phase II study to assess
efficacy and safety of the dabrafenib and trametinib combination in Japanese patients with
any line, stage IV NSCLC harboring a confirmed BRAF V600E mutation.
Patients will receive oral dabrafenib twice daily and oral trametinib once daily combination
therapy. Patients may continue study treatment until disease progression, unacceptable
adverse events, start of a new anti-cancer therapy, consent withdrawal, death, or end of the
study. Patients who have met the criteria for disease progression (PD) according to RECIST
v1.1 may continue to receive study treatment if the investigator believes the patient is
receiving clinical benefit and the patient is willing to continue on study treatment. After
discontinuation of study treatment, all patients will be followed for survival until death,
lost to follow-up, withdrawal of consent, or end of study.
n/a
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