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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Oral LGX818 300mg daily
University of Chicago Medical Center SC-2
Chicago, Illinois, United States
Overall Response Rate (ORR)
ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator
Time frame: up to 24 weeks
Overall Response Rate (ORR)
ORR per RECIST 1.1 as assessed by by Blinded independent review committee (BIRC)
Time frame: baseline, every 6 weeks up to 24 weeks
Progression-Free Survival (PFS)
PFS determined by investigator and BIRC.
Time frame: baseline, every 6 weeks up to 24 weeks
Duration of Response (DOR)
DOR by investigator and BIRC assessments.
Time frame: baseline, every 6 weeks up to 24 weeks
Overall survival (OS)
Overall survival (OS)
Time frame: baseline, every 6 weeks up to 24 weeks
Safety Profile
Adverse events and laboratory abnormalities
Time frame: baseline, every 3 weeks up to 24 weeks
Disease Control Rate (DCR)
DCR by investigator and BIRC assessments.
Time frame: baseline, every 6 weeks up to 24 weeks
Pharmacokinetics profile
Plasma concentration-time profiles of encorafenib (LGX818).
Time frame: baseline, every 3 weeks up to 18 weeks
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Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay
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)
Time frame: screening, up to 24 weeks