BRAF V600-mutated Lung Carcinoma Treated With the Combination of Dabrafenib-trametinib: a Retrospective Evaluation

NCT04775095 | Completed

• 1 other identifier: IFCT-2004
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 2

Brief Summary

BLaDE cohort will evaluate overall survival (OS), real world progression-free survival (PFS), best response and duration of treatment in patients with advanced, metastatic Non-Small Cell Lung Cancer (NSCLC) harboring BRAF V600E or non E mutation who received dabrafeninb-trametinib combination or not. Subsequent or previous treatments (treatments delivered after or before dabrafeninb-trametinib combination will be recorded). Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

Conditions

Non Small Cell Lung Cancer; BRAF V600 Mutation

Keywords

Non-Small Cell Lung Cancer; BRAF V600 Mutation; Real-world study; IFCT

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS) at 12 months in non-small cell lung cancer (NSCLC) BRAF V600E-mutated patients receiving the combination of dabrafenib-trametinib as second line or more treatment

  OS will be determined as the time from the first dose of treatment with dabrafenib-trametinib to death from any cause

  12 months

Secondary Outcomes (5)

• OS at 18 and 24 months and median OS in NSCLC BRAF V600E-mutated patients receiving the combination of dabrafenib-trametinib as second line or more treatment

  18 and 24 months

• OS at 12, 18 and 24 months and median OS in NSCLC BRAF V600E-mutated patients receiving the combination of dabrafenib-trametinib as first-line treatment

  at 12, 18 and 24 months

• OS at 12, 18 and 24 months and median OS in NSCLC BRAF V600E-mutated patients regardless of the treatment received

  at 12, 18 and 24

• OS at 12, 18 and 24 months and median OS in NSCLC BRAF V600E-mutated patients not treated by the combination of dabrafenib-trametinib, according to the treatment and the line received

  at 12, 18 and 24

• OS at 12 months and median OS in NSCLC BRAF V600 non E-mutated patients according to the treatment and the line received

  at 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with histologically or cytologically confirmed extensive stage NSCLC with BRAF V600 (E or non E) mutation diagnosed on tumor sample and/or on liquid biopsy (co mutations allowed) between 01/01/2016 and 31/12/2019

You may qualify if:

• Patients with histologically or cytologically confirmed extensive stage NSCLC
• Presence of BRAF V 600 E or non E mutation diagnosed on tumor sample and/or on liquid biopsy (co mutations allowed) between 01/01/2016 and 31/12/2019
• Patients who received at least one dose of treatment with dabrafenib-trametinib combination (whatever the treatment line)
• NSCLC BRAF V600 patients who have not received the dabrafenib-trametinib combination will be included for the collection of clinical and demographic data, treatments received and OS
• Patients who were informed about the study and do not refused for their data to be collected and used
• Age \> 18 years

You may not qualify if:

• Patients harboring a non V600 BRAF mutation
• Patients enrolled in a clinical trial assessing treatment with dabrafenib-trametinib combination
• Explicit refusal by the patient to collect his or her data
• Patients under curatorship or guardianship
• Unable to obtain data collection

Sponsors & Collaborators

• Intergroupe Francophone de Cancerologie Thoracique: lead
• Novartis: collaborator

Study Sites (2)

Créteil - CHI

Créteil, France

Location

Lyon - CRLCC

Lyon, France

Location

Related Links

• IFCT website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Bernard AULIAC, Dr

  Créteil -CHI

  STUDY CHAIR

• Aurélie SWALDUZ, Dr

  Lyon - CLCC

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: March 8, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)