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

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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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Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT02109653

Recruitment Status:

Withdrawn

Sponsor:

Array Biopharma, now a wholly owned subsidiary of Pfizer

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There is 1 Location for this study

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

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Study is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT02109653

Recruitment Status:

Withdrawn

Sponsor:


Array Biopharma, now a wholly owned subsidiary of Pfizer

How clear is this clinincal trial information?

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