Clinical trial NCT02109653: Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC,
Non-Small Cell Lung Cancer,
BRAF V600,
LGX818
Lead sponsor: Array BioPharma
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: baseline, every 6 weeks up to 24 weeks
measure: Progression-Free Survival (PFS)
timeFrame: baseline, every 6 weeks up to 24 weeks
measure: Duration of Response (DOR)
timeFrame: baseline, every 6 weeks up to 24 weeks
measure: Overall survival (OS)
timeFrame: baseline, every 6 weeks up to 24 weeks
measure: Safety Profile
timeFrame: baseline, every 3 weeks up to 24 weeks
measure: Disease Control Rate (DCR)
timeFrame: baseline, every 6 weeks up to 24 weeks
measure: Pharmacokinetics profile
timeFrame: baseline, every 3 weeks up to 18 weeks
measure: Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay
timeFrame: screening, up to 24 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center SC-2
state: Illinois
Study officials:
affiliation: 1-800-718-1021
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: