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

Primary Purpose

Non-small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
encorafenib
binimetinib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring lung cancer, cancer, non-small cell lung cancer, non small cell lung cancer, NSCLC, Encorafenib, Binimetinib, Phase 2, Open Label, BRAF mutation, BRAF V600E, Array, Stage IV NSCLC, Metastatic NSCLC, PDL1, PD-LI, Immunotherapy, First line platinum based chemotherapy, BRAF inhibitor, V600

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yuma Regional Medical Center Cancer Center
  • Yuma Regional Medical Center Ophthalmology
  • Yuma Regional Medical Center
  • UCLA Stein Eye Center Santa Monica (OPH)
  • UCLA Hematology/Oncology
  • Florida Cancer Specialist
  • Florida Cancer Specialists
  • Florida Cancer Specialist
  • Florida Cancer Specialists
  • Florida Cancer Specialist
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialist
  • Florida Cancer Specialists
  • Florida Cancer Specialist
  • Florida Cancer Specialists
  • Florida Cancer Specialist
  • Florida Cancer Specialist
  • Florida Cancer Specialist
  • Florida Cancer Specialists
  • Florida Cancer Specialist
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists PAN - SCRI - PPDS
  • Florida Cancer Specialist
  • Florida Cancer Specialist
  • Florida Cancer Specialist
  • Florida Cancer Specialist
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Winship Cancer Institute @ Emory University Hospital Midtown
  • Emory University Hospital
  • Winship Cancer Institute, Emory University
  • Winship Cancer Institute @ Emory Saint Joseph's Hospital
  • Winship Cancer Institute @ Emory Johns Creek Hospital
  • MidAmerica Division, Inc. c/o Menorah Medical Center
  • Johns Hopkins Bayview Medical Center
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • The Johns Hopkins Wilmer Eye Institute
  • Massachusetts General Hospital
  • Ophthalmic Consultants of Boston (OCB)
  • Ophthalmic Consultants of Boston Inc
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Dana Farber Cancer Institute
  • Beth Israel Deaconess Medical Center - 330 Brookline Ave
  • Beth Israel Deaconess Medical Center/East
  • Dana-Farber Cancer Institute - Chestnut Hill
  • Siteman Cancer Center - West County
  • MidAmerica Division, Inc. c/o Centerpoint Medical Center
  • MidAmerica Division, Inc., c/o Research Medical Center
  • Barnes-Jewish Hospital
  • Washington University School of Medicine
  • Siteman Cancer Center - South County
  • Siteman Cancer Center - St Peters
  • Memorial Sloan Kettering Cancer Center Basking Ridge
  • Hackensack University Medical Center
  • Metropolitan Eye Care
  • Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care
  • Weill Cornell Eye Associates
  • Weill Cornell Medical College - New York Presbyterian Hospital
  • Memorial Sloan Kettering Cancer Center
  • Weill Cornell Medical College - New York Presbyterian Hospital
  • Duke Cancer Center
  • Ohio State CarePoint East
  • The Ohio State University Hospital
  • The Ohio State University James Cancer Hospital
  • The Ohio State University Medical Center - Thoracic Oncology Clinic
  • Ohio State Eye and Ear Institute
  • Stefanie Spielman Comprehensive Breast Cancer
  • Martha Morehouse Medical Plaza
  • Ohio State CarePoint Gahanna
  • Ohio State Outpatient Care Lewis Center
  • Providence Cancer Institute Clackamas Clinic
  • Providence Cancer Institute Newberg Clinic
  • Providence Cancer Institute, Franz Clinic
  • Providence Oncology and Hematology Care Clinic - Westside
  • UPMC Hillman Cancer Center Erie
  • UPMC Hillman Cancer Center - Arnold Palmer - Mt View
  • UPMC Hillman Cancer Center Monroeville
  • UPMC Eye Center, Eye and Ear Institute
  • UPMC Hillman Cancer Center
  • UPMC Hillman Cancer Center - Passavant (HOA)
  • UPMC Hillman Cancer Center - Passavant (OHA)
  • UPMC Hillman Cancer Center - Upper St. Clair
  • Weaver Eye Associates
  • WellSpan Oncology Research
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Houston Eye Associates - Gramercy Location
  • The University of Texas MD Anderson Cancer Center
  • Millennium Research & Clinical Development
  • Eye associates Northwest
  • Seattle Cancer Care Alliance
  • Departimento Oncologia Medica
  • Unita Operativa di Oculistica: UO Oncologia Oculare e Immunopatologia oculare
  • Unita Operativa Radiologia
  • UO Anatomia e lstologia Patologica
  • UO Dermatologia e Cosmetologia
  • UO Medicina Nucleare
  • UOC Farmacia
  • S.S.D. Oncologia Polmonare
  • SCDO Cardiologia
  • SCDU Anatomia Patologica
  • SCDU Oftalmologia
  • SCDU Radiodiagnostica e S.S. Medicina Nucleare
  • Dermatologia Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
  • UO Dermatologia Centro Tumori Cutanei (CTC)- Azienda Ospedaliero
  • UO di Oftalmologia- Azienda Ospedaliero Universitaria Di Bologna
  • UO Farmacia Clinica- Azienda Ospedaliero Universitaria Di Bologna
  • UO Medicina Borghi- Azienda Ospedaliero Universitaria Di Bologna
  • UO Radiologia Golfieri- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
  • UOC di Anatomia Patologica- Azienda Ospedaliero Universitaria Di Bo logna
  • IRCCS Ospedale San Raffaele
  • Clinica Oculistica II, 2° Policlinico Federico II
  • S. C. Farmacia
  • Samsung Medical Center - PPDS
  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
  • OLVG, locatie Oost; Ophthalmology department
  • Ophthalmology department
  • University Medical Center Groningen
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Hospital Regional Universitario de Malaga - Hospital General
  • Hospital Clinic de Barcelona
  • Hospital del Mar
  • CETIR Centro Medico Teknon
  • Hospital Quiron Salud Barcelona
  • Hospital Universitario Vall d'Hebron
  • Grupo Cardiologico Corpal (Hospital de la Cruz Roja)
  • Hospital Universitario Reina Sofia
  • Cetir
  • lnstitut Catala d'Oncologia_L'Hospitalet
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario 12 de Octubre
  • Centro Hospitalario Integral Privado (CHIP)
  • CERCO
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen Del Rocio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Period

Arm Description

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)

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) as Determined by Independent Radiology Review (IRR) per RECIST v1.1 in the Treatment Naïve and Previously Treated Settings

Secondary Outcome Measures

Duration of Response (DOR) as Determined by Independent Radiology Review (IRR) and Investigator
Disease Control Rate (DCR) as Determined by Independent Radiology Review (IRR) and Investigator
Progression-free Survival (PFS) as Determined by Independent Radiology Review (IRR) and Investigator
Overall Survival (OS)
Incidence and severity of adverse events (AEs)
Objective Response Rate (ORR) as determined by Investigator based on RECIST v1.1
Time to Tumor Response (TTR) as determined by Independent Radiology Review (IRR) and Investigator

Full Information

First Posted
April 12, 2019
Last Updated
July 10, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03915951
Brief Title
An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer
Official Title
A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
lung cancer, cancer, non-small cell lung cancer, non small cell lung cancer, NSCLC, Encorafenib, Binimetinib, Phase 2, Open Label, BRAF mutation, BRAF V600E, Array, Stage IV NSCLC, Metastatic NSCLC, PDL1, PD-LI, Immunotherapy, First line platinum based chemotherapy, BRAF inhibitor, V600

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Period
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
encorafenib
Intervention Description
self-administered orally
Intervention Type
Drug
Intervention Name(s)
binimetinib
Intervention Description
self-administered orally
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) as Determined by Independent Radiology Review (IRR) per RECIST v1.1 in the Treatment Naïve and Previously Treated Settings
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) as Determined by Independent Radiology Review (IRR) and Investigator
Time Frame
Up to 24 months
Title
Disease Control Rate (DCR) as Determined by Independent Radiology Review (IRR) and Investigator
Time Frame
Up to 24 months
Title
Progression-free Survival (PFS) as Determined by Independent Radiology Review (IRR) and Investigator
Time Frame
Up to 24 months
Title
Overall Survival (OS)
Time Frame
Up to 24 months
Title
Incidence and severity of adverse events (AEs)
Time Frame
Up to 24 months
Title
Objective Response Rate (ORR) as determined by Investigator based on RECIST v1.1
Time Frame
Up to 24 Months
Title
Time to Tumor Response (TTR) as determined by Independent Radiology Review (IRR) and Investigator
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Yuma Regional Medical Center Cancer Center
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Facility Name
Yuma Regional Medical Center Ophthalmology
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Facility Name
Yuma Regional Medical Center
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Facility Name
UCLA Stein Eye Center Santa Monica (OPH)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
UCLA Hematology/Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Florida Cancer Specialist
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Florida Cancer Specialists
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34135
Country
United States
Facility Name
Florida Cancer Specialist
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Florida Cancer Specialists
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33909
Country
United States
Facility Name
Florida Cancer Specialist
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Florida Cancer Specialists
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Florida Cancer Specialist
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Florida Cancer Specialists
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Florida Cancer Specialist
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Florida Cancer Specialists
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Florida Cancer Specialist
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Florida Cancer Specialist
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Florida Cancer Specialist
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Florida Cancer Specialists
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Florida Cancer Specialist
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34236
Country
United States
Facility Name
Florida Cancer Specialists
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34608
Country
United States
Facility Name
Florida Cancer Specialists PAN - SCRI - PPDS
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Cancer Specialist
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Florida Cancer Specialist
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Florida Cancer Specialist
City
The Villages
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Florida Cancer Specialist
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Florida Cancer Specialists
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Facility Name
Florida Cancer Specialists
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Florida Cancer Specialists
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Winship Cancer Institute @ Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute @ Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Winship Cancer Institute @ Emory Johns Creek Hospital
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
Facility Name
MidAmerica Division, Inc. c/o Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
The Johns Hopkins Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Ophthalmic Consultants of Boston (OCB)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Ophthalmic Consultants of Boston Inc
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center - 330 Brookline Ave
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Beth Israel Deaconess Medical Center/East
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute - Chestnut Hill
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Siteman Cancer Center - West County
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
MidAmerica Division, Inc. c/o Centerpoint Medical Center
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
MidAmerica Division, Inc., c/o Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center - South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Siteman Cancer Center - St Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Metropolitan Eye Care
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Cornell Eye Associates
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Cornell Medical College - New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College - New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ohio State CarePoint East
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
The Ohio State University Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University Medical Center - Thoracic Oncology Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Ohio State Eye and Ear Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Stefanie Spielman Comprehensive Breast Cancer
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Martha Morehouse Medical Plaza
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Ohio State CarePoint Gahanna
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
Ohio State Outpatient Care Lewis Center
City
Lewis Center
State/Province
Ohio
ZIP/Postal Code
43035
Country
United States
Facility Name
Providence Cancer Institute Clackamas Clinic
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Providence Cancer Institute Newberg Clinic
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Facility Name
Providence Cancer Institute, Franz Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Oncology and Hematology Care Clinic - Westside
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
UPMC Hillman Cancer Center Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Facility Name
UPMC Hillman Cancer Center - Arnold Palmer - Mt View
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
UPMC Hillman Cancer Center Monroeville
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
UPMC Eye Center, Eye and Ear Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2548
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UPMC Hillman Cancer Center - Passavant (HOA)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
UPMC Hillman Cancer Center - Passavant (OHA)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
UPMC Hillman Cancer Center - Upper St. Clair
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Weaver Eye Associates
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17402
Country
United States
Facility Name
WellSpan Oncology Research
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Cleveland
State/Province
Tennessee
ZIP/Postal Code
37311
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Dickson
State/Province
Tennessee
ZIP/Postal Code
37055
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Gallatin
State/Province
Tennessee
ZIP/Postal Code
37066
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37090
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37207
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Shelbyville
State/Province
Tennessee
ZIP/Postal Code
37160
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Houston Eye Associates - Gramercy Location
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Millennium Research & Clinical Development
City
Houston
State/Province
Texas
ZIP/Postal Code
77090-3063
Country
United States
Facility Name
Eye associates Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Departimento Oncologia Medica
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Unita Operativa di Oculistica: UO Oncologia Oculare e Immunopatologia oculare
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Unita Operativa Radiologia
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
UO Anatomia e lstologia Patologica
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
UO Dermatologia e Cosmetologia
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
UO Medicina Nucleare
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
UOC Farmacia
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
S.S.D. Oncologia Polmonare
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
SCDO Cardiologia
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
SCDU Anatomia Patologica
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
SCDU Oftalmologia
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
SCDU Radiodiagnostica e S.S. Medicina Nucleare
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Dermatologia Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
UO Dermatologia Centro Tumori Cutanei (CTC)- Azienda Ospedaliero
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
UO di Oftalmologia- Azienda Ospedaliero Universitaria Di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
UO Farmacia Clinica- Azienda Ospedaliero Universitaria Di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
UO Medicina Borghi- Azienda Ospedaliero Universitaria Di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
UO Radiologia Golfieri- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
UOC di Anatomia Patologica- Azienda Ospedaliero Universitaria Di Bo logna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Clinica Oculistica II, 2° Policlinico Federico II
City
Napli
ZIP/Postal Code
80131
Country
Italy
Facility Name
S. C. Farmacia
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Samsung Medical Center - PPDS
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
City
Amsterdam
State/Province
Noord-holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
OLVG, locatie Oost; Ophthalmology department
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Ophthalmology department
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga - Hospital General
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Badalona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
CETIR Centro Medico Teknon
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Quiron Salud Barcelona
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Grupo Cardiologico Corpal (Hospital de la Cruz Roja)
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Cetir
City
Esplugues de Llobregat
ZIP/Postal Code
08950
Country
Spain
Facility Name
lnstitut Catala d'Oncologia_L'Hospitalet
City
L'Hospitalet
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro Hospitalario Integral Privado (CHIP)
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
CERCO
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
34918546
Citation
Riely GJ, Ahn MJ, Felip E, Ramalingam SS, Smit EF, Tsao AS, Alcasid A, Usari T, Wissel PS, Wilner KD, Johnson BE. Encorafenib plus binimetinib in patients with BRAFV600-mutant non-small cell lung cancer: phase II PHAROS study design. Future Oncol. 2022 Mar;18(7):781-791. doi: 10.2217/fon-2021-1250. Epub 2021 Dec 17.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=ARRAY-818-202
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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