Clinical Trials Logo
  1. Home
  2. Lung Non-Small Cell Carcinoma
  3. NCT04005144

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

Lung Non-Small Cell Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04005144
Study type Interventional
Source University of California, San Francisco
Contact
Status Terminated
Phase Phase 1
Start date February 25, 2020
Completion date October 1, 2022
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT04989283 - Testing the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy Treatment During Radiation Therapy for Superior Sulcus Non-small Cell Lung Cancer Phase 2
Recruiting NCT05106374 - Risk of Chemotherapy Toxicity in Older Patients With Blood Cancer or Non-small Cell Lung Cancer
Terminated NCT03707925 - Bronchoscopic Laser Ablation of Peripheral Lung Tumors N/A
Active, not recruiting NCT04013542 - Ipilimumab and Nivolumab in Combination With Radiation Therapy in Treating Patients With Stage 2-3 Non-small Lung Cancer Phase 1
Recruiting NCT04929041 - Testing the Addition of Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative Phase 2/Phase 3
Recruiting NCT04073745 - Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer Phase 1
Recruiting NCT05830058 - Positron Emission Tomography (PET) Guided Stereotactic Body Radiation Therapy for the Treatment of Oligoprogressive Non-small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma Phase 2
Active, not recruiting NCT03637816 - Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer Phase 2/Phase 3
Recruiting NCT04298606 - A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence Early Phase 1
Recruiting NCT06122064 - A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer N/A
Recruiting NCT05802186 - Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study N/A
Recruiting NCT03634241 - Pembrolizumab in Preventing Lung Cancer in Patients With Stage I-II Non-Small Cell Lung Cancer or High-Risk Pulmonary Nodules, the IMPRINT-Lung Study Phase 2
Recruiting NCT04314401 - National Cancer Institute "Cancer Moonshot Biobank"
Recruiting NCT05493566 - Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer Early Phase 1
Suspended NCT05501665 - Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer Phase 1/Phase 2
Withdrawn NCT04061590 - Pembrolizumab With or Without Chemotherapy Before Surgery in Treating Patients With Stage I-IIIA Non-Small Cell Lung Cancer Phase 2
Recruiting NCT06225427 - Gilteritinib for the Treatment of ALK NSCLC Phase 1
Not yet recruiting NCT06116682 - Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial) Phase 2
Withdrawn NCT04085081 - Physical Activity Intervention Before and After Surgery in Older Adults With Lung Cancer and Their Family Caregivers N/A
Active, not recruiting NCT03939481 - Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer