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Report for Clinical Trial NCT03543306

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open-label, Multicenter, Phase II Study of Dabrafenib and Trametinib in Patients With Non-small Cell Lung Cancer Harboring V600E BRAF Mutation

This is a Phase II, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib and trametinib in stage IV disease to subjects with BRAF V600E mutant advanced non-small cell lung cancer. Subjects will receive dabrafenib 150 mg bid and trametinib 2 mg once daily in combination therapy and continue on treatment until disease progression, death, or unacceptable adverse event.

NCT03543306 Cancer Lung Cancer Metastatic BRAF V600E
MeSH:Lung Neoplasms
HPO:Neoplasm of the lung

1 Interventions

Name: daborafenib plus trametinib

Description: Dabrafenib 150 mg twice daily and trametinib 2 mg once daily
Type: Drug


Primary Outcomes

Description: ORR is a proportion of patients with a best overall response defined as complete response or partial response by RECIST1.1

Measure: Objective response rate

Time: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

Secondary Outcomes

Description: DOR is calculated as the time from the date of the first document of complete remission (CR) or partial remission (PR) to the first documented preogressive disease (PD) or death due to any cause for patients with PR or CR.

Measure: Duration of response

Time: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

Description: . PFS is defined as time from the first dose of investigational products (IPs) to progression or death due to any cause. OS is defined as time from the first dose of IPs to death due to any cause.

Measure: Progression-free survival

Time: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

Measure: Overall survival

Time: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

Description: DCR is calculated as the proportion of patients with best response of CR, PR and SD.

Measure: Disease control rate

Time: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 V600E

An Open-label, Multicenter, Phase II Study of Dabrafenib and Trametinib in Patients With Non-small Cell Lung Cancer Harboring V600E BRAF Mutation. --- V600E ---

Dabrafenib and Trametinib in Patients With Non-small Cell Lung Cancer Harboring V600E BRAF Mutation This is a Phase II, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib and trametinib in stage IV disease to subjects with BRAF V600E mutant advanced non-small cell lung cancer. --- V600E ---

Dabrafenib and Trametinib in Patients With Non-small Cell Lung Cancer Harboring V600E BRAF Mutation This is a Phase II, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib and trametinib in stage IV disease to subjects with BRAF V600E mutant advanced non-small cell lung cancer. --- V600E --- --- V600E ---

Palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study treatment is allowed Cancer Lung Cancer Metastatic BRAF V600E Lung Neoplasms null --- V600E ---



HPO Nodes


HPO: