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

November 11, 2020 updated by: Array Biopharma, now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60546
        • University of Chicago Medical Center SC-2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: LGX818
Oral LGX818 300mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ANTICIPATED)

November 1, 2017

Study Completion (ANTICIPATED)

November 1, 2017

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (ESTIMATE)

April 10, 2014

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLGX818A2202
  • 2013-005014-34 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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