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Trial Title:
A Study in Patients With BRAF V600E-mutant Metastatic Non-small Cell Lung Cancer (OCTOPUS)
NCT ID:
NCT05546905
Condition:
Metastatic Non-small Cell Lung Cancer
BRAF V600 Mutation
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Metastatic Non-small Cell Lung Cancer
BRAF V600 Mutation
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
The study population will consist of adult patients diagnosed with mNSCLC with a BRAF
V600E mutation who initiated a first systemic treatment in the metastatic setting from
December 01, 2017 to study entry date (retrospectively enrolled patients), as well as
patients with BRAFV600E-mutant mNSCLC 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 second 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 in these patients.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
Address:
City:
Lyon
Zip:
69677
Country:
France
Status:
Recruiting
Contact:
Last name:
Audrey SERRES
Phone:
+33478865924
Email:
audrey.serres@chu-lyon.fr
Contact backup:
Last name:
Sebastien Couraud, Prof
Phone:
+33478864405
Email:
sebastien.couraud@chu-lyon.fr
Start date:
June 23, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Pierre Fabre Medicament
Agency class:
Industry
Collaborator:
Agency:
Iqvia Pty Ltd
Agency class:
Industry
Source:
Pierre Fabre Medicament
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05546905
