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Completed

NCT Number: NCT05546905

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

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.

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Key information

Conditions

Metastatic Non-small Cell Lung Cancer BRAF V600 Mutation Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Lyon, Auvergne-Rhône-Alpes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Description of treatment regiment/agents for first and second systemic treatment lines for mNSCLC

    Time frame: 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

  2. Description of line of treatment

    Time frame: 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

  3. Description of duration of treatment line

    Time frame: 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

  4. Time to treatment discontinuation

    Time frame: 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.

  5. Time to next treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study title

An Observational Study Describing Diagnosis and Treatment Patterns in Adults With Metastatic Non-small Cell Lung Cancer With BRAF V600E Mutation in Clinical Practice, to Assess Treatment Effectiveness and Quality of Life (OCTOPUS)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2022
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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