This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.
Name: LGX818
Description: Oral LGX818 300mg dailyType: DrugLGX818
Description: ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator
Measure: Overall Response Rate (ORR) Time: up to 24 weeksDescription: ORR per RECIST 1.1 as assessed by by Blinded independent review committee (BIRC)
Measure: Overall Response Rate (ORR) Time: baseline, every 6 weeks up to 24 weeksDescription: PFS determined by investigator and BIRC.
Measure: Progression-Free Survival (PFS) Time: baseline, every 6 weeks up to 24 weeksDescription: DOR by investigator and BIRC assessments.
Measure: Duration of Response (DOR) Time: baseline, every 6 weeks up to 24 weeksDescription: Overall survival (OS)
Measure: Overall survival (OS) Time: baseline, every 6 weeks up to 24 weeksDescription: Adverse events and laboratory abnormalities
Measure: Safety Profile Time: baseline, every 3 weeks up to 24 weeksDescription: DCR by investigator and BIRC assessments.
Measure: Disease Control Rate (DCR) Time: baseline, every 6 weeks up to 24 weeksDescription: Plasma concentration-time profiles of encorafenib (LGX818).
Measure: Pharmacokinetics profile Time: baseline, every 3 weeks up to 18 weeksDescription: Concordance rate between BRAF mutation status obtained using the investigational diagnostic test and the companion diagnostic assay which will be submitted for Pre-market approval (PMA)
Measure: Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay Time: screening, up to 24 weeksAllocation: Non-Randomized
Single Group Assignment
There is one SNP
Inclusion Criteria: - Presence of BRAF V600E mutation in tumor tissue - Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC - At least one measurable lesion as defined by RECIST v1.1 - Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC. --- V600E ---
- Impaired cardiovascular function or clinically significant cardiovascular diseases - Pregnant or lactating women or woman of childbearing potential Inclusion Criteria: - Presence of BRAF V600E mutation in tumor tissue - Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC - At least one measurable lesion as defined by RECIST v1.1 - Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC. --- V600E ---