Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC
|ClinicalTrials.gov Identifier: NCT02672358|
Recruitment Status : Withdrawn (Company Decision)
First Posted : February 3, 2016
Last Update Posted : August 10, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Cancer||Drug: Dabrafenib Drug: Trametinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||September 3, 2018|
|Estimated Primary Completion Date :||September 2, 2019|
|Estimated Study Completion Date :||December 7, 2020|
Experimental: Dabrafenib +Trametinib
Oral Dabrafenib plus Oral Trametinib
Oral Dabrafenib 150 mg BID
Oral Trametinib 2 mg QD
- Overall Response Rate (ORR) by investigator assessment [ Time Frame: Approximately 2 years ]ORR, defined as the percentage of patients with a confirmed CR or PR by investigator assessment as per RECIST v1.1 criteria
- Duration of response (DOR) [ Time Frame: Approximately 2 years ]DOR, defined for the subset of patients with confirmed CR or PR, as the time from first documented evidence of CR or PR until time of first documented disease progression or death due to any cause.
- Disease control rate (DCR) [ Time Frame: Approximately 2 years ]DCR, defined as the proportion of patients with best overall response of CR, PR, or SD.
- Progression-free survival (PFS) [ Time Frame: Approximately 2 years ]PFS, defined as the interval between first dose and the earliest date of disease progression or death due to any cause.
- Overall survival (OS) [ Time Frame: Approximately 2 years ]OS, defined as the time from the date of first dose until death due to any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672358
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|