Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC
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.
Checked against the public recordLast updated Nov 13, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Interventions being studied
- Drug: LGX818
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Chicago Medical Center SC-2Chicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 13, 2020. Always confirm current availability with the study team.