A Study in Patients With BRAF V600E-mutant Metastatic Non-small Cell Lung Cancer (OCTOPUS)
About the study
Who can take part
INCLUSION 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
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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Study Details
Contition
Metastatic Non-small Cell Lung Cancer,BRAF V600 Mutation
Age
18+
Participants Needed
200
Est. Completion Date
Dec 31, 2024
Treatment Type
OBSERVATIONAL
Sponsor
Pierre Fabre Medicament
ClinicalTrials.gov NCT Identifier
NCT05546905
Study Number
NIS12500
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?