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

NCT02109653 | Withdrawn Phase 2

• 2 other identifiers: CLGX818A22022013-005014-34
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC,; Non-Small Cell Lung Cancer,; BRAF V600,; LGX818

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

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

  up to 24 weeks

Secondary Outcomes (8)

• 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

• Overall survival (OS)

  baseline, every 6 weeks up to 24 weeks

• Safety Profile

  baseline, every 3 weeks up to 24 weeks

Study Arms (1)

LGX818

EXPERIMENTAL

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.

Drug: LGX818

Interventions

LGX818 DRUG

Oral LGX818 300mg daily

LGX818

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Array Biopharma, now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

University of Chicago Medical Center SC-2

Chicago, Illinois, 60546, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

encorafenib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  1-800-718-1021

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: April 10, 2014
• Study Start: June 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

US (1)