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

NCT03915951

Last updated date
Study Location
Yuma Regional Medical Center Cancer Center
Yuma, Arizona, 85364, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: encorafenib
    self-administered orally
  • Drug: binimetinib
    self-administered orally
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:

  • Encorafenib: 450 mg (6 × 75 mg capsule) once daily (QD)
  • Binimetinib: 45 mg (3 × 15 mg tablet) twice daily (BID)
Interventions:
  • Drug: encorafenib
  • Drug: binimetinib
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
 (submitted: February 7, 2021)
90
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
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:

  • 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 × 10?/L;
    • Platelets ? 100 × 10?/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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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