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

Phase 2

Withdrawn

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: LGX818

• Registration Number: NCT02109653
• Lead Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-10
• Study Start: 2015-06
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LGX818	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	up to 24 weeks	ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator

Secondary Outcome Measures

Name	Time	Method
Safety Profile	baseline, every 3 weeks up to 24 weeks	Adverse events and laboratory abnormalities
Disease Control Rate (DCR)	baseline, every 6 weeks up to 24 weeks	DCR 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)
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.
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)
Pharmacokinetics profile	baseline, every 3 weeks up to 18 weeks	Plasma concentration-time profiles of encorafenib (LGX818).

Trial Locations

Locations (1)

University of Chicago Medical Center SC-2; 🇺🇸 Chicago, Illinois, United States