Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC,, Non-Small Cell Lung Cancer,, BRAF V600,, LGX818
Brief summary
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.
Interventions
DRUGLGX818
Oral LGX818 300mg daily
Sponsors
Array Biopharma, now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2
Exclusion criteria
* Patients with symptomatic Central Nervous System (CNS) metastases * History of leptomeningeal metastases * Prior therapy with a BRAF inhibitor * Patients taking prohibited medication listed in the protocol * Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. * Impaired cardiovascular function or clinically significant cardiovascular diseases * Pregnant or lactating women or woman of childbearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | up to 24 weeks | ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | baseline, every 6 weeks up to 24 weeks | PFS determined by investigator and BIRC. |
| Duration of Response (DOR) | baseline, every 6 weeks up to 24 weeks | DOR by investigator and BIRC assessments. |
| Overall survival (OS) | baseline, every 6 weeks up to 24 weeks | Overall survival (OS) |
| Overall Response Rate (ORR) | baseline, every 6 weeks up to 24 weeks | ORR per RECIST 1.1 as assessed by by Blinded independent review committee (BIRC) |
| Disease Control Rate (DCR) | baseline, every 6 weeks up to 24 weeks | DCR by investigator and BIRC assessments. |
| Pharmacokinetics profile | baseline, every 3 weeks up to 18 weeks | Plasma concentration-time profiles of encorafenib (LGX818). |
| Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay | screening, up to 24 weeks | 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) |
| Safety Profile | baseline, every 3 weeks up to 24 weeks | Adverse events and laboratory abnormalities |
Countries
United States
Outcome results
None listed