A Study in Patients With BRAF V600E-mutant Metastatic Non-small Cell Lung Cancer (OCTOPUS)

Recruiting

• Conditions: BRAF V600 Mutation; Metastatic Non-small Cell Lung Cancer

• Registration Number: NCT05546905
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

This study aims to describe the treatment patterns in clinical practice in adult patients with mNSCLC with a BRAF V600E mutation. This study will also describe Real-World Progression-Free Survival (rwPFS) and Overall Survival (OS) for treatments prescribed in routine practice for mNSCLC with BRAF V600E mutation. Adverse events (AEs) related to treatment management will also be described.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-23
• Study First Submitted: 2022-06-23
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-14
• Last Update Submitted: 2022-09-14
• Study First Posted: 2022-09-21
• Last Update Posted: 2022-09-21
• Primary Completion: 2023-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age ≥ 18 years at the time of first-line treatment initiation for mNSCLC,
• Patients who initiated a first systemic treatment for mNSCLC in the metastatic setting from 01 December 2017 and before their study entry date (retrospectively enrolled patients), or Patients who initiated a first systemic treatment for mNSCLC (metastatic setting) at or after their study entry date (prospectively enrolled patients),
• Confirmed diagnosis of Stage IV mNSCLCat any time before study inclusion Stage IV M1a, M1borM1c, as per the American Joint Committee on Cancer (AJCC cancer) staging manual,
• Confirmed presence of BRAF V600E mutation - via tumor biopsy, metastasectomy, or liquid biopsy - at anytime before study inclusion,
• Signed ICF or non-opposition to study participation,according to local regulations.

Patients eligible for prospective QoL data collection must, in addition to the above mentioned criteria, meet ALL of the following criteria to be eligible for the study:

• Patients who initiate a first or second systemic treatment line for mNSCLC (metastatic setting) with a BRAF V600E mutation at or after their study entry date

Exclusion Criteria

• Concurrent or another previous malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, in-situcarcinoma of the cervix, Bowen's disease or Gleason ≤ 6 prostate cancer,
• Previous, ongoing, or planned participation in a clinical trial involving an interventional drug as a first-or second-line systemic treatment for mNSCLC.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of treatment regiment/agents for first and second systemic treatment lines for mNSCLC	From the start of first or second line treatment to progression or date of death from any cause,assessed up to 30 months	Names of regimens/agents
Time to treatment discontinuation	From the start of first or second line treatment to the treatment discontinuation or death,assessed up to 30 months	Time to treatment discontinuation defined as the time between the date of start of a medication and the date of treatment discontinuation or death.
Description of line of treatment	From the start of first or second line treatment to the end of second line treatment,assessed up to 30 months	Line of treatment number overall, not limited to metastatic setting
Description of duration of treatment line	From the start of first or second line treatment to the end of line treatment,assessed up to 30 months	Duration of treatment line = End date of treatment line - Start date of treatment line
Time to next treatment	From the start of first or second line treatment to the subsequent line treatment,assessed up to 30 months	Time to next treatment defined as the time between the date of start of a medication and the date of start of the next LoT.

Trial Locations

Locations (1)

CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel; 🇫🇷 Lyon, Rhône Alpes, France