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

  • STATUS
    Recruiting
  • End date
    Mar 17, 2024
  • participants needed
    90
  • sponsor
    Pfizer
Updated on 1 December 2021
systemic therapy
measurable disease
metastasis
neutrophil count
cancer chemotherapy
platinum-based chemotherapy
stage iv non-small cell lung cancer
kidney function test
lung carcinoma
secondary malignant neoplasm of liver

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-nave, 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.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Binimetinib, Encorafenib
Clinical Study IdentifierNCT03915951
SponsorPfizer
Last Modified on1 December 2021

Eligibility

Yes No Not Sure

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-nave (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/1.73m

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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