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.
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.
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There are 117 Locations for this study
Yuma Arizona, 85364, United States
Yuma Arizona, 85364, United States
Yuma Arizona, 85364, United States
Santa Monica California, 90403, United States
Santa Monica California, 90404, United States
Altamonte Springs Florida, 32701, United States
Bonita Springs Florida, 34135, United States
Brandon Florida, 33511, United States
Cape Coral Florida, 33909, United States
Clearwater Florida, 33761, United States
Fleming Island Florida, 32003, United States
Fort Myers Florida, 33905, United States
Fort Myers Florida, 33908, United States
Gainesville Florida, 32605, United States
Largo Florida, 33770, United States
Lecanto Florida, 34461, United States
Naples Florida, 34102, United States
Ocala Florida, 34474, United States
Orange City Florida, 32763, United States
Orlando Florida, 32806, United States
Port Charlotte Florida, 33980, United States
Saint Petersburg Florida, 33705, United States
Sarasota Florida, 34232, United States
Sarasota Florida, 34236, United States
Spring Hill Florida, 34608, United States
Tallahassee Florida, 32308, United States
Tampa Florida, 33607, United States
Tavares Florida, 32778, United States
The Villages Florida, 32159, United States
Trinity Florida, 34655, United States
Venice Florida, 34285, United States
Venice Florida, 34292, United States
Winter Park Florida, 32792, United States
Atlanta Georgia, 30308, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Johns Creek Georgia, 30097, United States
Overland Park Kansas, 66209, United States
Baltimore Maryland, 21224, United States
Baltimore Maryland, 21231, United States
Baltimore Maryland, 21287, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Newton Massachusetts, 02459, United States
Creve Coeur Missouri, 63141, United States
Independence Missouri, 64057, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63129, United States
Saint Peters Missouri, 63376, United States
Basking Ridge New Jersey, 07920, United States
Hackensack New Jersey, 07601, United States
Paramus New Jersey, 07652, United States
New York New York, 10021, United States
New York New York, 10021, United States
New York New York, 10021, United States
New York New York, 10065, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Columbus Ohio, 43203, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43212, United States
Columbus Ohio, 43212, United States
Columbus Ohio, 43221, United States
Gahanna Ohio, 43230, United States
Lewis Center Ohio, 43035, United States
Clackamas Oregon, 97015, United States
Newberg Oregon, 97132, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Erie Pennsylvania, 16505, United States
Greensburg Pennsylvania, 15601, United States
Monroeville Pennsylvania, 15146, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15232, United States
Pittsburgh Pennsylvania, 15237, United States
Pittsburgh Pennsylvania, 15237, United States
Pittsburgh Pennsylvania, 15243, United States
York Pennsylvania, 17402, United States
York Pennsylvania, 17403, United States
Chattanooga Tennessee, 37404, United States
Cleveland Tennessee, 37311, United States
Dickson Tennessee, 37055, United States
Franklin Tennessee, 37067, United States
Gallatin Tennessee, 37066, United States
Hendersonville Tennessee, 37075, United States
Hermitage Tennessee, 37076, United States
Lebanon Tennessee, 37090, United States
Murfreesboro Tennessee, 37129, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37207, United States
Nashville Tennessee, 37211, United States
Shelbyville Tennessee, 37160, United States
Smyrna Tennessee, 37167, United States
Houston Texas, 77008, United States
Houston Texas, 77030, United States
Houston Texas, 77090, United States
Seattle Washington, 98104, United States
Seattle Washington, 98109, United States
Milan Lombardia, 20132, Italy
Milan Lombardia, 20132, Italy
Milan Lombardia, 20132, Italy
Milan Lombardia, 20132, Italy
Milan Lombardia, 20132, Italy
Milan Lombardia, 20132, Italy
Milan Lombardia, 20132, Italy
Orbassano Torino, 10043, Italy
Orbassano Torino, 10043, Italy
Orbassano Torino, 10043, Italy
Orbassano Torino, 10043, Italy
Orbassano Torino, 10043, Italy
Torino TO, 10126, Italy
Bologna , 40138, Italy
Bologna , 40138, Italy
Bologna , 40138, Italy
Bologna , 40138, Italy
Bologna , 40138, Italy
Bologna , 40138, Italy
Milan , 20132, Italy
Napli , 80131, Italy
Napoli , 80131, Italy
Seoul , 06351, Korea, Republic of
Seoul , 06351, Korea, Republic of
Amsterdam Noord-holland, 1066 , Netherlands
Amsterdam , 1066 , Netherlands
Amsterdam , 1091 , Netherlands
Groningen , 9713 , Netherlands
Groningen , 9713 , Netherlands
Majadahonda Madrid, 28222, Spain
Malaga Málaga, 29010, Spain
Badalona , 08036, Spain
Barcelona , 08003, Spain
Barcelona , 08022, Spain
Barcelona , 08023, Spain
Barcelona , 08035, Spain
Cordoba , 14004, Spain
Cordoba , 14004, Spain
Esplugues de Llobregat , 08950, Spain
L'Hospitalet , 08907, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Sevilla , 41009, Spain
Sevilla , 41009, Spain
Sevilla , 41013, Spain
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