An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600E-mutant Non-small Cell Lung Cancer
NCT03915951
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- 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
- 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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Descriptive Information | |||||||
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Brief Title ICMJE | An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600E-mutant Non-small Cell Lung Cancer | ||||||
Official Title ICMJE | A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Non-small Cell Lung Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE | 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:
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 90 | ||||||
Original Estimated Enrollment ICMJE | 40 | ||||||
Estimated Study Completion Date ICMJE | March 17, 2024 | ||||||
Estimated Primary Completion Date | June 29, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Italy, Korea, Republic of, Netherlands, Spain, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03915951 | ||||||
Other Study ID Numbers ICMJE | ARRAY-818-202 C4221008 ( Other Identifier: Alias Study Number ) 2019-000417-37 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |