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

July 21, 2025 updated by: Pierre Fabre Medicament

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Angers, France
        • CHU Angers - Hôpital Larrey
      • Créteil, France
        • Centre Hospitalier Intercommunal de Créteil
      • Douai, France
        • Centre Hospitalier de Douai
      • Nantes, France
        • CHU Nantes - Hôpital Guillaume et René Laënnec
      • Poitiers, France
        • CHU Poitiers - Hôpital la Milétrie
      • Rennes, France
        • CHU Rennes - Hôpital Pontchaillou
      • Strasbourg, France
        • CHU Strasbourg - nouvel hôpital Civil
      • Vantoux, France
        • UNEOS - Hopital Robert Schuman
    • Rhône Alpes
      • Lyon, Rhône Alpes, France, 69677
        • CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
  • Germany
      • Essen, Germany
        • Kliniken Essen-Mitte
      • Gießen, Germany
        • Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
      • Mainz, Germany
        • Marienhaus Klinikum Mainz
      • Mönchengladbach, Germany
        • Kliniken Maria Hilf GmbH
      • München, Germany
        • LMU-Campus Innenstadt
      • Münnerstadt, Germany
        • Thoraxzentrum Unterfranken
  • Italy
      • Alessandria, Italy
        • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
      • Avellino, Italy
        • Azienda Ospedaliera San Giuseppe Moscati
      • Bergamo, Italy
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
      • Brescia, Italy
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Meldola, Italy
        • IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST
      • Milano, Italy
        • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
      • Monserrato, Italy
        • AOU Cagliari- P.O. Policlinico Universitario Duilio Casula
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria- Università Degli Studi Della Campania "Luigi Vanvitelli"
      • Pisa, Italy
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Spain
      • A Coruña, Spain
        • Complejo Hospitalario Universitario A Coruña
      • Badalona, Spain
        • ICO Badalona - Hospital Universitari Germans Trias i Pujol
      • Madrid, Spain
        • Hospital Universitario Hm Madrid Sanchinarro
      • Majadahonda, Spain
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Málaga, Spain
        • Hospital Regional Universitario de Málaga
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Palma De Mallorca, Spain
        • Fundacion Hospital Son Llatzer
      • San Cristóbal de La Laguna, Spain
        • Complejo Hospitalario Universitario de Canarias
      • Seville, Spain
        • Hospital Universitario Virgen del Rocío
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe
      • Zaragoza, Spain
        • Hospital Clínico Universitario Lozano Blesa
  • United Kingdom
      • London, United Kingdom
        • Royal Marsden Hospital- London
      • Nottingham, United Kingdom
        • Nottingham University Hospitals City Campus
      • Whitchurch, United Kingdom
        • Velindre Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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 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.
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 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.
From the start of first or second line treatment to the subsequent line treatment,assessed up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pierre Fabre Medicament

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IQVIA Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: François Denjean, Pierre Fabre Medicament

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIS12500

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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