An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer
18 Years and older, Male and Female
ARRAY-818-202 (primary)
NCI-2019-02644
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.
Eligibility
- 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 × 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.
Treatment Sites in Georgia
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