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An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600E-mutant Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03915951
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Array BioPharma

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: encorafenib Drug: binimetinib Phase 2

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Study Type : Interventional
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600E-mutant Non-small Cell Lung Cancer
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 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)
Drug: encorafenib
self-administered orally

Drug: binimetinib
self-administered orally




Primary Outcome Measures :
  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Up to 24 months ]
  2. Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]
  3. Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]
  4. Overall Survival (OS) [ Time Frame: Up to 24 months ]
  5. Incidence and severity of adverse events (AEs) [ Time Frame: Up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915951


Contacts
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Contact: Array BioPharma, Inc 303-381-6604 clinicaltrials@arraybiopharma.com
Contact: Study Director 303-381-6604

Locations
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United States, Connecticut
Array BioPharma Investigative Site Recruiting
Norwich, Connecticut, United States, 06360
United States, Florida
Array BioPharma Investigative Site Recruiting
Fort Myers, Florida, United States, 33901
United States, New York
Array BioPharma Investigative Site Recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Array BioPharma
Investigators
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Study Director: Study Director Array BioPharma, Inc

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Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT03915951     History of Changes
Other Study ID Numbers: ARRAY-818-202
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Array BioPharma:
lung cancer
cancer
non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms