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WithdrawnPhase 2NCT02109653
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLGX818

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · BRAF · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 13, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Array Biopharma, now a wholly owned subsidiary of Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
Interventions being studied
Drug: LGX818
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→
Biomarkers
BRAF→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Chicago Medical Center SC-2Chicago, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 13, 2020. Always confirm current availability with the study team.

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