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Report for Clinical Trial NCT02672358

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT02672358 Non-Small-Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Dabrafenib

Description: Oral Dabrafenib 150 mg BID
Type: Drug
Group Labels: 1

Dabrafenib +Trametinib

Name: Trametinib

Description: Oral Trametinib 2 mg QD
Type: Drug
Group Labels: 1

Dabrafenib +Trametinib


Primary Outcomes

Description: ORR, defined as the percentage of patients with a confirmed CR or PR by investigator assessment as per RECIST v1.1 criteria

Measure: Overall Response Rate (ORR) by investigator assessment

Time: Approximately 2 years

Secondary Outcomes

Description: 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.

Measure: Duration of response (DOR)

Time: Approximately 2 years

Description: DCR, defined as the proportion of patients with best overall response of CR, PR, or SD.

Measure: Disease control rate (DCR)

Time: Approximately 2 years

Description: PFS, defined as the interval between first dose and the earliest date of disease progression or death due to any cause.

Measure: Progression-free survival (PFS)

Time: Approximately 2 years

Description: OS, defined as the time from the date of first dose until death due to any cause.

Measure: Overall survival (OS)

Time: Approximately 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

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. --- V600E ---

Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC 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. --- V600E ---

Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC 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. --- V600E --- --- V600E ---

OS, defined as the time from the date of first dose until death due to any cause.. Inclusion Criteria: - Histologically- or cytologically-confirmed diagnosis of NSCLC stage IV (according to AJCC Staging 7th Edition) - Presence of a BRAF V600E mutation in lung cancer tissue. --- V600E ---

BRAF V600E mutation tested by local laboratory (e.g. --- V600E ---

Inclusion Criteria: - Histologically- or cytologically-confirmed diagnosis of NSCLC stage IV (according to AJCC Staging 7th Edition) - Presence of a BRAF V600E mutation in lung cancer tissue. --- V600E ---



HPO Nodes


HPO: