New drug combo shows promise for Hard-to-Treat lung cancer

NCT ID NCT03915951

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of two targeted drugs, encorafenib and binimetinib, in 98 people with advanced non-small cell lung cancer that has a specific BRAF gene mutation. The goal was to see if the drugs could shrink tumors and how safe they were. Participants had either not received prior treatment or had already tried chemotherapy or immunotherapy.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

98 people

The number who actually took part.

Started

Jun 2019

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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. Key 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.

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Conditions

The condition(s) this trial relates to.

lung neoplasm neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States
Beth Israel Deaconess Medical Center/East

Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
CERCO

Seville, 41009, Spain
CETIR Centro Medico Teknon

Barcelona, 08022, Spain
Centro Hospitalario Integral Privado (CHIP)

Málaga, 29010, Spain
Cetir

Esplugues de Llobregat, 08950, Spain
Clinica Oculistica II, 2° Policlinico Federico II

Napli, Napli, 80131, Italy
Dana Farber / Partners Cancer Care

Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute - Chestnut Hill

Newton, Massachusetts, 02459, United States
Dermatologia Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino

Torino, TO, 10126, Italy
Duke Cancer Center

Durham, North Carolina, 27710, United States
Emory University Hospital

Atlanta, Georgia, 30322, United States
Eye associates Northwest

Seattle, Washington, 98104, United States
Florida Cancer Specialist

Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialist

Brandon, Florida, 33511, United States
Florida Cancer Specialist

Clearwater, Florida, 33761, United States
Florida Cancer Specialist

Gainesville, Florida, 32605, United States
Florida Cancer Specialist

Lecanto, Florida, 34461, United States
Florida Cancer Specialist

Ocala, Florida, 34474, United States
Florida Cancer Specialist

Orange City, Florida, 32763, United States
Florida Cancer Specialist

Orlando, Florida, 32806, United States
Florida Cancer Specialist

St. Petersburg, Florida, 33705, United States
Florida Cancer Specialist

Tampa, Florida, 33607, United States
Florida Cancer Specialist

Tavares, Florida, 32778, United States
Florida Cancer Specialist

The Villages, Florida, 32159, United States
Florida Cancer Specialist

Trinity, Florida, 34655, United States
Florida Cancer Specialists

Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists

Cape Coral, Florida, 33909, United States
Florida Cancer Specialists

Fleming Island, Florida, 32003, United States
Florida Cancer Specialists

Fort Myers, Florida, 33901, United States
Florida Cancer Specialists

Fort Myers, Florida, 33905, United States
Florida Cancer Specialists

Fort Myers, Florida, 33908, United States
Florida Cancer Specialists

Fort Myers, Florida, 33916, United States
Florida Cancer Specialists

Largo, Florida, 33770, United States
Florida Cancer Specialists

Naples, Florida, 34102, United States
Florida Cancer Specialists

Port Charlotte, Florida, 33980, United States
Florida Cancer Specialists

Sarasota, Florida, 34232, United States
Florida Cancer Specialists

Sarasota, Florida, 34236, United States
Florida Cancer Specialists

Spring Hill, Florida, 34608, United States
Florida Cancer Specialists

Venice, Florida, 34285, United States
Florida Cancer Specialists

Venice, Florida, 34292, United States
Florida Cancer Specialists

Winter Park, Florida, 32792, United States
Florida Cancer Specialists PAN - SCRI - PPDS

Tallahassee, Florida, 32308, United States
Grupo Cardiologico Corpal (Hospital de la Cruz Roja)

Córdoba, 14004, Spain
Hackensack University Medical Center

Edison, New Jersey, 08837, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands
Hospital Clinic de Barcelona

Badalona, 08036, Spain
Hospital Quiron Salud Barcelona

Barcelona, 08023, Spain
Hospital Regional Universitario de Malaga - Hospital General

Málaga, Málaga, 29010, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain
Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain
Hospital Universitario Reina Sofia

Córdoba, 14004, Spain
Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain
Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain
Hospital Universitario Virgen Macarena

Seville, 41009, Spain
Hospital del Mar

Barcelona, 08003, Spain
Houston Eye Associates - Gramercy Location

Houston, Texas, 77008, United States
IRCCS Ospedale San Raffaele

Milan, 20132, Italy
Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale

Naples, 80131, Italy
Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States
Martha Morehouse Medical Plaza

Columbus, Ohio, 43221, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Memorial Hospital

Shiloh, Illinois, 62269, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care

New York, New York, 10021, United States
Metropolitan Eye Care

Paramus, New Jersey, 07652, United States
MidAmerica Division, Inc. c/o Centerpoint Medical Center

Independence, Missouri, 64057, United States
MidAmerica Division, Inc. c/o Menorah Medical Center

Overland Park, Kansas, 66209, United States
MidAmerica Division, Inc., c/o Research Medical Center

Kansas City, Missouri, 64132, United States
Millennium Research & Clinical Development

Houston, Texas, 77090, United States
OLVG, locatie Oost; Ophthalmology department

Amsterdam, 1091 AC, Netherlands
Ohio State CarePoint East

Columbus, Ohio, 43203, United States
Ohio State CarePoint Gahanna

Gahanna, Ohio, 43230, United States
Ohio State Eye and Ear Institute

Columbus, Ohio, 43212, United States
Ohio State Outpatient Care Lewis Center

Lewis Center, Ohio, 43035, United States
Ophthalmic Consultants of Boston (OCB)

Boston, Massachusetts, 02114, United States
Ophthalmic Consultants of Boston Inc

Boston, Massachusetts, 02114, United States
Ophthalmology department

Groningen, 9713 GZ, Netherlands
Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, 97015, United States
Providence Cancer Institute Newberg Clinic

Newberg, Oregon, 97132, United States
Providence Cancer Institute, Franz Clinic

Portland, Oregon, 97213, United States
Providence Oncology and Hematology Care Clinic - Westside

Portland, Oregon, 97225, United States
Regional Cancer Care Associates, LLC

Hackensack, New Jersey, 07601, United States
S.S.D. Oncologia Polmonare

Orbassano, Torino, 10043, Italy
SCDU Radiodiagnostica e S.S. Medicina Nucleare

Orbassano, Torino, 10043, Italy
Saint Louis Children's Hospital

St Louis, Missouri, 63110, United States
Samsung Medical Center - PPDS

Seoul, 06351, South Korea
Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States
Siteman Cancer Center

St Louis, Missouri, 63108, United States
Siteman Cancer Center - Shiloh

Shiloh, Illinois, 62269, United States
Siteman Cancer Center - South County

St Louis, Missouri, 63129, United States
Siteman Cancer Center - St Peters

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County

Creve Coeur, Missouri, 63141, United States
Stefanie Spielman Comprehensive Breast Cancer

Columbus, Ohio, 43212, United States
Tennessee Oncology, PLLC

Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC

Cleveland, Tennessee, 37311, United States
Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC

Shelbyville, Tennessee, 37160, United States
The Johns Hopkins Wilmer Eye Institute

Baltimore, Maryland, 21287, United States
The Ohio State University East Hospital

Columbus, Ohio, 43203, United States
The Ohio State University East Hospital Ohio State Outpatient Care New Albany

Westerville, Ohio, 43081, United States
The Ohio State University Hospital

Columbus, Ohio, 43210, United States
The Ohio State University James Cancer Hospital

Columbus, Ohio, 43210, United States
The Ohio State University Medical Center - Thoracic Oncology Clinic

Columbus, Ohio, 43210, United States
The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States
UCLA Hematology/Oncology

Los Angeles, California, 90095, United States
UCLA Hematology/Oncology

Santa Monica, California, 90404, United States
UCLA Stein Eye Center Santa Monica (OPH)

Santa Monica, California, 90403, United States
UO di Oftalmologia- Azienda Ospedaliero Universitaria Di Bologna

Bologna, 40138, Italy
UOC di Anatomia Patologica- Azienda Ospedaliero Universitaria Di Bo logna

Bologna, 40138, Italy
UPMC Eye Center, Eye and Ear Institute

Pittsburgh, Pennsylvania, 15213, United States
UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
UPMC Hillman Cancer Center - Arnold Palmer - Mt View

Greensburg, Pennsylvania, 15601, United States
UPMC Hillman Cancer Center - Passavant (HOA)

Pittsburgh, Pennsylvania, 15237, United States
UPMC Hillman Cancer Center - Passavant (OHA)

Pittsburgh, Pennsylvania, 15237, United States
UPMC Hillman Cancer Center - Upper St. Clair

Pittsburgh, Pennsylvania, 15243, United States
UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505, United States
UPMC Hillman Cancer Center Monroeville

Monroeville, Pennsylvania, 15146, United States
Unita Operativa Radiologia

Milan, Lombardy, 20132, Italy
University Medical Center Groningen

Groningen, 9713 GZ, Netherlands
Washington University

St Louis, Missouri, 63110, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Weaver Eye Associates

York, Pennsylvania, 17402, United States
Weill Cornell Eye Associates

New York, New York, 10021, United States
Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, 10021, United States
Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, 10065, United States
WellSpan Health

York, Pennsylvania, 17403, United States
WellSpan Oncology Research

York, Pennsylvania, 17403, United States
Winship Cancer Institute @ Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States
Winship Cancer Institute @ Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States
Winship Cancer Institute @ Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States
Yuma Regional Medical Center

Yuma, Arizona, 85364, United States
Yuma Regional Medical Center Cancer Center

Yuma, Arizona, 85364, United States
Yuma Regional Medical Center Ophthalmology

Yuma, Arizona, 85364, United States
lnstitut Catala d'Oncologia_L'Hospitalet

L'Hospitalet de Llobregat, 08907, Spain

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