Metastatic Non-small Cell Lung CancerNCT05546905
A Study in Patients With BRAF V600E-mutant Metastatic Non-small Cell Lung Cancer (OCTOPUS)
An observational study of Metastatic Non-small Cell Lung Cancer and BRAF V600 Mutation, run by Pierre Fabre Medicament at 39 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer, BRAF V600 Mutation
- How many people
- 206 participants
- Where
- 39 sitesin 5 countries
- Study dates
- 23 Jun 2022to 7 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
39 sites in 5 countries.
39 sites in 5 countries
Spain11 sites
Complejo Hospitalario Universitario A Coruña
A Coruña
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona
Hospital Universitario HM Madrid Sanchinarro
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Hospital Regional Universitario de Malaga
Málaga
Hospital Universitario Central de Asturias
Oviedo
Fundacion Hospital Son Llatzer
Palma de Mallorca
Complejo Hospitalario Universitario de Canarias
San Cristóbal de La Laguna
Hospital Universitario Virgen del Rocio
Seville
Hospital Universitari i Politecnic La Fe
Valencia
Hospital Clinico Universitario Lozano Blesa
Zaragoza
Italy10 sites
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria
Azienda Ospedaliera San Giuseppe Moscati
Avellino
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST
Meldola
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan
AOU Cagliari- P.O. Policlinico Universitario Duilio Casula
Monserrato
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Naples
Azienda Ospedaliero Universitaria Pisana
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
France9 sites
CHU Angers - Hôpital Larrey
Angers
Centre Hospitalier Intercommunal de Créteil
Créteil
Centre Hospitalier de Douai
Douai
CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
Lyon, Auvergne-Rhône-Alpes, 69677
CHU Nantes - Hôpital Guillaume et René Laënnec
Nantes
CHU Poitiers - Hôpital la Milétrie
Poitiers
CHU Rennes - Hopital Pontchaillou
Rennes
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg
UNEOS - Hopital Robert Schuman
Vantoux
Germany6 sites
Kliniken Essen-Mitte
Essen
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
Giessen
Marienhaus Klinikum Mainz
Mainz
Kliniken Maria Hilf GmbH
Mönchengladbach
LMU-Campus Innenstadt
München
Thoraxzentrum Unterfranken
Münnerstadt
United Kingdom3 sites
Royal Marsden Hospital- London
London
Nottingham University Hospitals City Campus
Nottingham
Velindre Cancer Centre
Whitchurch
About this study
Official 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)
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.
- Keywords
- Metastatic Non-small Cell Lung Cancer, BRAF V600 Mutation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of treatment regiment/agents for first and second systemic treatment lines for mNSCLC
Names of regimens/agents
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: From the start of first or second line treatment to the subsequent line treatment,assessed up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start23 Jun 2022
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- François Denjean, Study director, Pierre Fabre Médicament
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546905
- Sponsor's protocol ID
- NIS12500
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2022
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05546905
- Acronym / sponsor ID
- NIS12500
- Keywords
- Metastatic Non-small Cell Lung Cancer, BRAF V600 Mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Denjean study director
Pierre Fabre Médicament
39 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Non-small Cell Lung Cancer and BRAF V600 Mutation, run by Pierre Fabre Medicament at 39 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Spain, Italy, France, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.