Breast Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

98

Study ID:

NCT03915951

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 117 Locations for this study

See Locations Near You

Yuma Regional Medical Center Cancer Center
Yuma Arizona, 85364, United States
Yuma Regional Medical Center Ophthalmology
Yuma Arizona, 85364, United States
Yuma Regional Medical Center
Yuma Arizona, 85364, United States
UCLA Stein Eye Center Santa Monica (OPH)
Santa Monica California, 90403, United States
UCLA Hematology/Oncology
Santa Monica California, 90404, United States
Florida Cancer Specialist
Altamonte Springs Florida, 32701, United States
Florida Cancer Specialists
Bonita Springs Florida, 34135, United States
Florida Cancer Specialist
Brandon Florida, 33511, United States
Florida Cancer Specialists
Cape Coral Florida, 33909, United States
Florida Cancer Specialist
Clearwater Florida, 33761, United States
Florida Cancer Specialists
Fleming Island Florida, 32003, United States
Florida Cancer Specialists
Fort Myers Florida, 33905, United States
Florida Cancer Specialists
Fort Myers Florida, 33908, United States
Florida Cancer Specialist
Gainesville Florida, 32605, United States
Florida Cancer Specialists
Largo Florida, 33770, United States
Florida Cancer Specialist
Lecanto Florida, 34461, United States
Florida Cancer Specialists
Naples Florida, 34102, 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 Specialists
Port Charlotte Florida, 33980, United States
Florida Cancer Specialist
Saint Petersburg Florida, 33705, 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 PAN - SCRI - PPDS
Tallahassee Florida, 32308, 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
Venice Florida, 34285, United States
Florida Cancer Specialists
Venice Florida, 34292, United States
Florida Cancer Specialists
Winter Park Florida, 32792, United States
Winship Cancer Institute @ Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Winship Cancer Institute @ Emory Saint Joseph's Hospital
Atlanta Georgia, 30342, United States
Winship Cancer Institute @ Emory Johns Creek Hospital
Johns Creek Georgia, 30097, United States
MidAmerica Division, Inc. c/o Menorah Medical Center
Overland Park Kansas, 66209, United States
Johns Hopkins Bayview Medical Center
Baltimore Maryland, 21224, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21231, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21287, United States
The Johns Hopkins Wilmer Eye Institute
Baltimore Maryland, 21287, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Ophthalmic Consultants of Boston (OCB)
Boston Massachusetts, 02114, United States
Ophthalmic Consultants of Boston Inc
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center/East
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton Massachusetts, 02459, United States
Siteman Cancer Center - West County
Creve Coeur Missouri, 63141, United States
MidAmerica Division, Inc. c/o Centerpoint Medical Center
Independence Missouri, 64057, United States
MidAmerica Division, Inc., c/o Research Medical Center
Kansas City Missouri, 64132, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Siteman Cancer Center - South County
Saint Louis Missouri, 63129, United States
Siteman Cancer Center - St Peters
Saint Peters Missouri, 63376, United States
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge New Jersey, 07920, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Metropolitan Eye Care
Paramus New Jersey, 07652, United States
Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care
New York New York, 10021, 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
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York New York, 10065, United States
Duke Cancer Center
Durham North Carolina, 27710, United States
Ohio State CarePoint East
Columbus Ohio, 43203, 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
Ohio State Eye and Ear Institute
Columbus Ohio, 43212, United States
Stefanie Spielman Comprehensive Breast Cancer
Columbus Ohio, 43212, United States
Martha Morehouse Medical Plaza
Columbus Ohio, 43221, United States
Ohio State CarePoint Gahanna
Gahanna Ohio, 43230, United States
Ohio State Outpatient Care Lewis Center
Lewis Center Ohio, 43035, United States
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
UPMC Hillman Cancer Center Erie
Erie Pennsylvania, 16505, United States
UPMC Hillman Cancer Center - Arnold Palmer - Mt View
Greensburg Pennsylvania, 15601, United States
UPMC Hillman Cancer Center Monroeville
Monroeville Pennsylvania, 15146, United States
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 - 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
Weaver Eye Associates
York Pennsylvania, 17402, United States
WellSpan Oncology Research
York Pennsylvania, 17403, United States
Tennessee Oncology, PLLC
Chattanooga Tennessee, 37404, United States
Tennessee Oncology, PLLC
Cleveland Tennessee, 37311, United States
Tennessee Oncology, PLLC
Dickson Tennessee, 37055, United States
Tennessee Oncology, PLLC
Franklin Tennessee, 37067, United States
Tennessee Oncology, PLLC
Gallatin Tennessee, 37066, United States
Tennessee Oncology, PLLC
Hendersonville Tennessee, 37075, United States
Tennessee Oncology, PLLC
Hermitage Tennessee, 37076, United States
Tennessee Oncology, PLLC
Lebanon Tennessee, 37090, United States
Tennessee Oncology, PLLC
Murfreesboro Tennessee, 37129, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37205, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37207, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37211, United States
Tennessee Oncology, PLLC
Shelbyville Tennessee, 37160, United States
Tennessee Oncology, PLLC
Smyrna Tennessee, 37167, United States
Houston Eye Associates - Gramercy Location
Houston Texas, 77008, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Millennium Research & Clinical Development
Houston Texas, 77090, United States
Eye associates Northwest
Seattle Washington, 98104, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Departimento Oncologia Medica
Milan Lombardia, 20132, Italy
Unita Operativa di Oculistica: UO Oncologia Oculare e Immunopatologia oculare
Milan Lombardia, 20132, Italy
Unita Operativa Radiologia
Milan Lombardia, 20132, Italy
UO Anatomia e lstologia Patologica
Milan Lombardia, 20132, Italy
UO Dermatologia e Cosmetologia
Milan Lombardia, 20132, Italy
UO Medicina Nucleare
Milan Lombardia, 20132, Italy
UOC Farmacia
Milan Lombardia, 20132, Italy
S.S.D. Oncologia Polmonare
Orbassano Torino, 10043, Italy
SCDO Cardiologia
Orbassano Torino, 10043, Italy
SCDU Anatomia Patologica
Orbassano Torino, 10043, Italy
SCDU Oftalmologia
Orbassano Torino, 10043, Italy
SCDU Radiodiagnostica e S.S. Medicina Nucleare
Orbassano Torino, 10043, Italy
Dermatologia Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
Torino TO, 10126, Italy
UO Dermatologia Centro Tumori Cutanei (CTC)- Azienda Ospedaliero
Bologna , 40138, Italy
UO di Oftalmologia- Azienda Ospedaliero Universitaria Di Bologna
Bologna , 40138, Italy
UO Farmacia Clinica- Azienda Ospedaliero Universitaria Di Bologna
Bologna , 40138, Italy
UO Medicina Borghi- Azienda Ospedaliero Universitaria Di Bologna
Bologna , 40138, Italy
UO Radiologia Golfieri- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna , 40138, Italy
UOC di Anatomia Patologica- Azienda Ospedaliero Universitaria Di Bo logna
Bologna , 40138, Italy
IRCCS Ospedale San Raffaele
Milan , 20132, Italy
Clinica Oculistica II, 2° Policlinico Federico II
Napli , 80131, Italy
S. C. Farmacia
Napoli , 80131, Italy
Samsung Medical Center - PPDS
Seoul , 06351, Korea, Republic of
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam Noord-holland, 1066 , Netherlands
OLVG, locatie Oost; Ophthalmology department
Amsterdam , 1091 , Netherlands
Ophthalmology department
Groningen , 9713 , Netherlands
University Medical Center Groningen
Groningen , 9713 , Netherlands
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda Madrid, 28222, Spain
Hospital Regional Universitario de Malaga - Hospital General
Malaga Málaga, 29010, Spain
Hospital Clinic de Barcelona
Badalona , 08036, Spain
Hospital del Mar
Barcelona , 08003, Spain
CETIR Centro Medico Teknon
Barcelona , 08022, Spain
Hospital Quiron Salud Barcelona
Barcelona , 08023, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Grupo Cardiologico Corpal (Hospital de la Cruz Roja)
Cordoba , 14004, Spain
Hospital Universitario Reina Sofia
Cordoba , 14004, Spain
CETIR
Esplugues de Llobregat , 08950, Spain
lnstitut Catala d'Oncologia_L'Hospitalet
L'Hospitalet , 08907, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Centro Hospitalario Integral Privado (CHIP)
Malaga , 29010, Spain
CERCO
Sevilla , 41009, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

98

Study ID:

NCT03915951

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

×

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