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

Array Biopharma, now a wholly owned subsidiary of Pfizer1 site in 1 countryJune 2015

ConditionsNon-Small Cell Lung Cancer

InterventionsLGX818

DrugsLGX818

Overview

Phase: Phase 2
Intervention: LGX818
Conditions: Non-Small Cell Lung Cancer
Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer
Locations: 1
Primary Endpoint: Overall Response Rate (ORR)
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

November 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

LGX818

Adult patients, with confirmed diagnosis of BRAF V600E mutant advanced or metastatic NSCLC who have progressed on or after at least one prior systemic anticancer therapy.

Intervention: LGX818

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

Time Frame: up to 24 weeks

ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator

Secondary Outcomes

Overall survival (OS)(baseline, every 6 weeks up to 24 weeks)
Overall Response Rate (ORR)(baseline, every 6 weeks up to 24 weeks)
Progression-Free Survival (PFS)(baseline, every 6 weeks up to 24 weeks)
Duration of Response (DOR)(baseline, every 6 weeks up to 24 weeks)
Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay(screening, up to 24 weeks)
Safety Profile(baseline, every 3 weeks up to 24 weeks)
Disease Control Rate (DCR)(baseline, every 6 weeks up to 24 weeks)
Pharmacokinetics profile(baseline, every 3 weeks up to 18 weeks)