Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT05546905
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05546905
Study Brief:
Protocol Section:
NCT05546905