This phase I trial studies the side effects and best dose of brigatinib and binimetinib in
treating patients with stage IIIB-IV non-small cell lung cancer and a type of gene mutation
called a rearrangement in the ALK or ROS1 genes. Brigatinib and binimetinib may stop the
growth of tumor cells by blocking some of the enzymes needed for cell growth.
I. To determine the safety and tolerability of brigatinib in combination with binimetinib in
stage IIIB or IV anaplastic lymphoma kinase (ALK) or ROS1 rearranged non-small cell lung
cancer (NSCLC) and the recommended phase 2 dose.
I. To determine preliminary efficacy of brigatinib in combination with binimetinib in any
line of treatment.
II. To characterize the pharmacokinetic parameters of brigatinib in combination with
I. To assess circulating tumor deoxyribonucleic acid (DNA) (ctDNA) utility in evaluating
II. To evaluate the blockade of downstream signaling indicating response or resistance to
treatment of immunohistochemistry (IHC) for phosphatidylinositol 3-kinase (PI3K)/Protein
kinase B (AKT)/Mitogen-activated protein kinase (MAPK) pathway activity evaluation.
OUTLINE: This a dose-escalation study.
Patients receive brigatinib orally (PO) once daily (QD) and binimetinib PO twice daily (BID)
on days 1-28. Cycles repeat every 28 days in the absence of disease progression or
After completion of study treatment, patients are followed up for 30 days and then every 6
months for 12 months.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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