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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915951
Recruitment Status : Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: N/A
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 BRAFV600-mutant Non-small Cell Lung Cancer
Actual Study Start Date : June 4, 2019
Actual Primary Completion Date : September 22, 2022
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Duration of Response (DOR) as Determined by Independent Radiology Review (IRR) and Investigator [ Time Frame: Up to 24 months ]
  2. Disease Control Rate (DCR) as Determined by Independent Radiology Review (IRR) and Investigator [ Time Frame: Up to 24 months ]
  3. Progression-free Survival (PFS) as Determined by Independent Radiology Review (IRR) and Investigator [ 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 ]
  6. Objective Response Rate (ORR) as determined by Investigator based on RECIST v1.1 [ Time Frame: Up to 24 Months ]
  7. Time to Tumor Response (TTR) as determined by Independent Radiology Review (IRR) and Investigator [ Time Frame: Up to 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03915951    
Other Study ID Numbers: ARRAY-818-202
C4221008 ( Other Identifier: Alias Study Number )
2019-000417-37 ( EudraCT Number )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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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 Pfizer:
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
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