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An Open-label Study of Encora...

An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer

Last Updated: 2025-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2025-10-03

Brief Summary

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This is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in combination with binimetinib in patients with BRAFV600E-mutant metastatic non-small cell lung cancer (NSCLC). Patients who are either treatment-naïve, OR who have received 1) first-line treatment with standard platinum-based chemotherapy, OR 2) first-line treatment with an anti-programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) inhibitor given alone or in combination with platinum-based chemotherapy will be enrolled.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Period

Study treatment with encorafenib and binimetinib will be self-administered orally without regard to food.

Patients will receive the following per 28-day (± 3 days) cycle:

* Encorafenib: 450 mg (6 × 75 mg capsule) once daily (QD)
* Binimetinib: 45 mg (3 × 15 mg tablet) twice daily (BID)

Group Type EXPERIMENTAL

encorafenib

Intervention Type DRUG

self-administered orally

binimetinib

Intervention Type DRUG

self-administered orally

Interventions

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encorafenib

self-administered orally

Intervention Type DRUG

binimetinib

self-administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is currently Stage IV.
* Presence of a BRAFV600E mutation in lung cancer tissue as determined by a local laboratory assay or the presence of other BRAFV600 mutations other than V600E (i.e. K or D) will be considered
* Patients who are either treatment-naïve (e.g., no prior systemic therapy for advanced/metastatic disease), OR who have received 1) first-line platinum-based chemotherapy OR 2) first-line treatment with an anti-programmed cell death protein 1 (PD-1)/ programmed cell death protein ligand 1(PD-L1) inhibitor given alone or in combination with platinum-based chemotherapy.
* Presence of measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
* Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1.
* Adequate bone marrow function characterized by the following at screening:

* absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
* Platelets ≥ 100 × 10⁹/L;
* Hemoglobin ≥ 8.5 g/dL (with or without blood transfusions).
* Adequate hepatic and renal function characterized by the following at screening:

* Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
* alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN in presence of liver metastases; Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula; or estimated glomerular filtration rate \> 50 mL/min/1.73m².

Exclusion Criteria

* Patients who have documentation of any of the following:

* epidermal growth factor receptor (EGFR) mutation
* anaplastic lymphoma kinase (ALK) fusion oncogene or
* ROS1 rearrangement
* Patients who have received more than 1 prior line of systemic therapy in the advanced/metastatic setting.
* Previous treatment with any BRAF inhibitor (e.g., dabrafenib, vemurafenib, XL281/BMS-908662, etc.), or any mitogen-activated protein kinase (MEK) inhibitor (e.g., trametinib, cobimetinib, selumetinib, RDEA119, etc.) prior to screening and enrollment.
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to the first dose of study treatment. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or sub-massive) deep vein thrombosis or pulmonary emboli.
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of retinal degenerative disease.
* Concurrent neuromuscular disorder that is associated with the potential of elevated creatine (phospho)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
* Patients with symptomatic brain metastasis, leptomeningeal disease or other active central nervous system (CNS) metastases are not eligible.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Yuma Regional Medical Center Cancer Center

Yuma, Arizona, United States

Site Status

Yuma Regional Medical Center Ophthalmology

Yuma, Arizona, United States

Site Status

Yuma Regional Medical Center

Yuma, Arizona, United States

Site Status

UCLA Stein Eye Center Santa Monica (OPH)

Santa Monica, California, United States

Site Status

UCLA Hematology/Oncology

Santa Monica, California, United States

Site Status

Florida Cancer Specialist

Altamonte Springs, Florida, United States

Site Status

Florida Cancer Specialists

Bonita Springs, Florida, United States

Site Status

Florida Cancer Specialist

Brandon, Florida, United States

Site Status

Florida Cancer Specialists

Cape Coral, Florida, United States

Site Status

Florida Cancer Specialist

Clearwater, Florida, United States

Site Status

Florida Cancer Specialists

Fleming Island, Florida, United States

Site Status

Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialist

Gainesville, Florida, United States

Site Status

Florida Cancer Specialists

Largo, Florida, United States

Site Status

Florida Cancer Specialist

Lecanto, Florida, United States

Site Status

Florida Cancer Specialists

Naples, Florida, United States

Site Status

Florida Cancer Specialist

Ocala, Florida, United States

Site Status

Florida Cancer Specialist

Orange City, Florida, United States

Site Status

Florida Cancer Specialist

Orlando, Florida, United States

Site Status

Florida Cancer Specialists

Port Charlotte, Florida, United States

Site Status

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status

Florida Cancer Specialists

Spring Hill, Florida, United States

Site Status

Florida Cancer Specialist

St. Petersburg, Florida, United States

Site Status

Florida Cancer Specialists PAN - SCRI - PPDS

Tallahassee, Florida, United States

Site Status

Florida Cancer Specialist

Tampa, Florida, United States

Site Status

Florida Cancer Specialist

Tavares, Florida, United States

Site Status

Florida Cancer Specialist

The Villages, Florida, United States

Site Status

Florida Cancer Specialist

Trinity, Florida, United States

Site Status

Florida Cancer Specialists

Venice, Florida, United States

Site Status

Florida Cancer Specialists

Venice, Florida, United States

Site Status

Florida Cancer Specialists

Winter Park, Florida, United States

Site Status

Winship Cancer Institute @ Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Site Status

Winship Cancer Institute @ Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status

Winship Cancer Institute @ Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Site Status

MidAmerica Division, Inc. c/o Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status