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

NCT05546905 | Completed

• 1 other identifier: NIS12500
• Study Type: observational
• Target: 206
• Locations: 5 countries
• Sites: 39

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.

Conditions

Metastatic Non-small Cell Lung Cancer; BRAF V600 Mutation

Keywords

Metastatic Non-small Cell Lung Cancer; BRAF V600 Mutation

Outcome Measures

Primary Outcomes (5)

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

  Names of regimens/agents

  From the start of first or second line treatment to progression or date of death from any cause,assessed up to 30 months

• Description of line of treatment

  Line of treatment number overall, not limited to metastatic setting

  From the start of first or second line treatment to the end of second line treatment,assessed up to 30 months

• Description of duration of treatment line

  Duration of treatment line = End date of treatment line - Start date of treatment line

  From the start of first or second line treatment to the end of line treatment,assessed up to 30 months

• Time to treatment discontinuation

  Time to treatment discontinuation defined as the time between the date of start of a medication and the date of treatment discontinuation or death.

  From the start of first or second line treatment to the treatment discontinuation or death,assessed up to 30 months

• Time to next treatment

  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.

  From the start of first or second line treatment to the subsequent line treatment,assessed up to 30 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

The study population consists of adult patients diagnosed with mNSCLC BRAF V600E mutation who initiated a 1st systemic (retrospectively enrolled patients), and patients who initiated a first metastatic treatment upon inclusion (prospectively enrolled patients). Retrospectively enrolled patients can also be eligible for second-line prospective QoL data collection and contribute to a sub-cohort of prospective patients initiating their 2nd line of treatment (LoT) after study entry. The study aims to enroll approximately 200 patients, of whom 50 patients are planned to complete full prospective follow-up for their first-line and/or second-line systemic treatment given in the metastatic setting in mNSCLC allowing for prospective QoL data collection.

You may qualify if:

• 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),
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pierre Fabre Medicament: lead
• Iqvia Pty Ltd: collaborator

Study Sites (39)

CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

Lyon, Auvergne-Rhône-Alpes, 69677, France

Location

CHU Angers - Hôpital Larrey

Angers, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Location

Centre Hospitalier de Douai

Douai, France

Location

CHU Nantes - Hôpital Guillaume et René Laënnec

Nantes, France

Location

CHU Poitiers - Hôpital la Milétrie

Poitiers, France

Location

CHU Rennes - Hopital Pontchaillou

Rennes, France

Location

CHU Strasbourg - Nouvel Hôpital Civil

Strasbourg, France

Location

UNEOS - Hopital Robert Schuman

Vantoux, France

Location

Kliniken Essen-Mitte

Essen, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

Giessen, Germany

Location

Marienhaus Klinikum Mainz

Mainz, Germany

Location

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany

Location

LMU-Campus Innenstadt

München, Germany

Location

Thoraxzentrum Unterfranken

Münnerstadt, Germany

Location

Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Location

Azienda Ospedaliera San Giuseppe Moscati

Avellino, Italy

Location

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

Bergamo, Italy

Location

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

Brescia, Italy

Location

IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST

Meldola, Italy

Location

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

Milan, Italy

Location

AOU Cagliari- P.O. Policlinico Universitario Duilio Casula

Monserrato, Italy

Location

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

Napoli, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Location

ICO Badalona - Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Location

Hospital Universitario HM Madrid Sanchinarro

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Fundacion Hospital Son Llatzer

Palma de Mallorca, Spain

Location

Complejo Hospitalario Universitario de Canarias

San Cristóbal de La Laguna, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

Location

Royal Marsden Hospital- London

London, United Kingdom

Location

Nottingham University Hospitals City Campus

Nottingham, United Kingdom

Location

Velindre Cancer Centre

Whitchurch, United Kingdom

Location

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

• François Denjean

  Pierre Fabre Médicament

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: September 21, 2022
• Study Start: June 23, 2022
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

IT (10); FR (9); GB (3); DE (6); ES (11)