Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC

A Phase II, Single Arm, Open-label, Multicenter, Study of Oral LGX818 in Patients With BRAF V600 Mutant, Advanced Non-small Cell Lung Cancer (NSCLC) That Have Progressed During or After at Least One Prior Chemotherapy

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.

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