NCT04005144

Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer

A Phase I Study of Brigatinib With Binimetinib in Advanced ALK- or ROS1-Rearranged Non-Small Cell Lung Cancer (NSCLC)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 binimetinib. EXPLORATORY OBJECTIVES: I. To assess circulating tumor deoxyribonucleic acid (DNA) (ctDNA) utility in evaluating treatment response. 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 unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 6 months for 12 months.

Conditions

• ALK Gene Rearrangement
• Lung Non-Small Cell Carcinoma
• Progressive Disease
• ROS1 Gene Rearrangement
• Stage IIIB Lung Cancer
• Stage IIIC Lung Cancer
• Stage IV Lung Cancer
• Stage IVA Lung Cancer
• Stage IVB Lung Cancer

Interventions

Type	Name	Description
DRUG	Binimetinib	Given PO
DRUG	Brigatinib	Given PO

Timeline

• Start date: 2020-02-25
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2019-07-02
• Last updated: 2022-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study