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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT02672358
Eligibility Criteria:
Inclusion Criteria:
* Histologically- or cytologically-confirmed diagnosis of NSCLC stage IV (according to AJCC Staging 7th Edition)
* Presence of a BRAF V600E mutation in lung cancer tissue. BRAF V600E mutation tested by local laboratory (e.g. study center laboratory, local laboratory company) with proper quality control and license to operation by local health authority is allowed.
* Measurable disease according to RECIST v1.1.
Exclusion Criteria:
* Previous treatment with a BRAF inhibitor (including but not limited to dabrafenib, vemurafenib, encorafenib, and XL281/BMS-908662) or MEK inhibitor (including but not limited to trametinib, cobimetinib, binimetinib, AZD6244, and RDEA119) prior to start of study treatment
* Patients with brain metastases are excluded if their brain metastases are:
* Symptomatic OR
* Treated (surgery, radiation therapy) but not clinically and radiographically stable 3 weeks after local therapy (as assessed by contrast enhanced magnetic resonance imaging \[MRI\] or computed tomography \[CT\]), OR
* Asymptomatic and untreated but \>1 cm in the longest dimension
* History of malignancy with confirmed activating RAS mutation at any time.
* History of interstitial lung disease or pneumonitis
* A history or current evidence of retinal vein occlusion (RVO)
* Current evidence of unstable aneurysm or one that needs treatment
Other protocol-defined inclusion/exclusion may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02672358
Study Brief:
Protocol Section:
NCT02672358