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

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03915951
Protocol IDs
ARRAY-818-202 (primary)
NCI-2019-02644
Study Sponsor
Pfizer Inc

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

  1. Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is currently Stage IV.
  2. 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
  3. 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.
  4. Presence of measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
  5. Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1.
  6. Adequate bone marrow function characterized by the following at screening:
  7. absolute neutrophil count (ANC) = 1.5 × 10?/L;
  8. Platelets = 100 × 10?/L;
  9. Hemoglobin = 8.5 g/dL (with or without blood transfusions).
  10. Adequate hepatic and renal function characterized by the following at screening:
  11. Total bilirubin = 1.5 × upper limit of normal (ULN)
  12. 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

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.