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

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

Non Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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 details
    Metastatic Non-small Cell Lung Cancer
    BRAF V600 Mutation

NCT05546905

Pierre Fabre Medicament

20 August 2025

FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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