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

NCT ID: NCT02109653

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-11-30

Brief Summary

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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

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Conditions

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Non-Small Cell Lung Cancer

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

LGX818

Intervention Type DRUG

Oral LGX818 300mg daily

Interventions

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LGX818

Oral LGX818 300mg daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Array Biopharma, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

1-800-718-1021

Locations

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University of Chicago Medical Center SC-2

Chicago, Illinois, United States

Site Status

Countries

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Argentina Bulgaria Canada France Germany Italy Japan Lebanon Mexico Netherlands Russia Singapore Spain Thailand Turkey (Türkiye) United States

Other Identifiers

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2013-005014-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLGX818A2202

Identifier Type: -

Identifier Source: org_study_id