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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02109653
• Other study ID #: CLGX818A2202
• Secondary ID: 2013-005014-34
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2020
• Source: Array BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• LGX818
Oral LGX818 300mg daily

Locations

Country	Name	City	State
United States	University of Chicago Medical Center SC-2	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Array Biopharma, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator	up to 24 weeks
Secondary	Overall Response Rate (ORR)	ORR per RECIST 1.1 as assessed by by Blinded independent review committee (BIRC)	baseline, every 6 weeks up to 24 weeks
Secondary	Progression-Free Survival (PFS)	PFS determined by investigator and BIRC.	baseline, every 6 weeks up to 24 weeks
Secondary	Duration of Response (DOR)	DOR by investigator and BIRC assessments.	baseline, every 6 weeks up to 24 weeks
Secondary	Overall survival (OS)	Overall survival (OS)	baseline, every 6 weeks up to 24 weeks
Secondary	Safety Profile	Adverse events and laboratory abnormalities	baseline, every 3 weeks up to 24 weeks
Secondary	Disease Control Rate (DCR)	DCR by investigator and BIRC assessments.	baseline, every 6 weeks up to 24 weeks
Secondary	Pharmacokinetics profile	Plasma concentration-time profiles of encorafenib (LGX818).	baseline, every 3 weeks up to 18 weeks
Secondary	Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay	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)	screening, up to 24 weeks