NCT05546905Completed
A Study in Patients With BRAF V600E-mutant Metastatic Non-small Cell Lung Cancer (OCTOPUS)
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)
Source: ClinicalTrials.gov · Last updated 22 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 206 (actual)
- First submitted
- 23 Jun 2022
- Start date
- 23 Jun 2022
- Primary completion date
- 7 Jan 2025
- Lead sponsor
- Pierre Fabre Medicament
- Diseases
- Lung cancer
- NCT number
- NCT05546905
What you commit to
- Study type: Observational
- Participants enrolled: 206
- From 23 Jun 2022 to the primary completion date, 7 Jan 2025
- 39 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous, ongoing, or planned participation in a clinical trial involving an interventional drug as a first-or second-line systemic treatment for mNSCLC.
Other illness
- 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,
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (39)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kliniken Essen-Mitte Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
| Marienhaus Klinikum Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Kliniken Maria Hilf GmbH Coordinator of this site? Confirm its status | Mönchengladbach | Germany | Unknown status |
| LMU-Campus Innenstadt Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Thoraxzentrum Unterfranken Coordinator of this site? Confirm its status | Münnerstadt | Germany | Unknown status |
| Complejo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| ICO Badalona - Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Universitario HM Madrid Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Fundacion Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Complejo Hospitalario Universitario de Canarias Coordinator of this site? Confirm its status | San Cristóbal de La Laguna | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| CHU Angers - Hôpital Larrey Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Centre Hospitalier Intercommunal de Créteil Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Centre Hospitalier de Douai Coordinator of this site? Confirm its status | Douai | France | Unknown status |
| CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CHU Nantes - Hôpital Guillaume et René Laënnec Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU Poitiers - Hôpital la Milétrie Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| CHU Rennes - Hopital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHU Strasbourg - Nouvel Hopital Civil Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| UNEOS - Hopital Robert Schuman Coordinator of this site? Confirm its status | Vantoux | France | Unknown status |
| Royal Marsden Hospital - London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Nottingham University Hospitals City Campus Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Velindre Cancer Centre Coordinator of this site? Confirm its status | Whitchurch | United Kingdom | Unknown status |
| Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo Coordinator of this site? Confirm its status | Alessandria | Italy | Unknown status |
| Azienda Ospedaliera San Giuseppe Moscati Coordinator of this site? Confirm its status | Avellino | Italy | Unknown status |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| AOU Cagliari- P.O. Policlinico Universitario Duilio Casula Coordinator of this site? Confirm its status | Monserrato | Italy | Unknown status |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.