Loading clinical trials...

TERMINATEDPHASE2

Brigatinib Before Brain Irradiation Trial (B3i Trial)

Brigatinib Before Brain Irradiation Trial (B3i Trial): A Phase II Trial of Brigatinib Alone for Brain Metastases From ALK+ Lung Cancer

NCT04634110•University of Colorado, Denver

View on ClinicalTrials.gov

Summary

This is a single arm phase II study of brigatinib alone for patients with brain metastases from anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC), who have either not been treated previously with a tyrosine kinase inhibitor (TKI) targeting ALK or who have had prior exposure to crizotinib.

Detailed Description

In this single-arm phase II trial, patients with brain metastases from ALK+ NSCLC will be treated with brigatinib alone without upfront brain irradiation. Patients will have close monitoring with clinical follow up visits and brain magnetic resonance imaging (MRI) surveillance, which will maximize safety and allow for early treatment if disease progression is observed. If brigatinib alone can demonstrate high rates of CNS disease control, these data could support a strategy of upfront brigatinib alone for carefully selected patients with brain metastases from ALK+ NSCLC.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision to sign and date the consent form.
•2. Stated willingness to comply with all study procedures and be available for the duration of the study.
•3. Ability to take and retain oral medications.
•4. Age ≥18 years.
•5. Patients with ALK+ lung cancer with evidence of ≥1 previously untreated brain metastases on brain MRI. Prior therapy (radiation or surgery) for brain metastases is allowed. However, patients must have ≥1 previously untreated at the time of enrollment.
•6. Patients may be ALK TKI naïve OR have had prior crizotinib therapy.
•7. Patients may be included if they are asymptomatic from their brain metastases (RTOG/EORTC grade 0) or if they have mild symptoms from their brain metastases not to exceed RTOG/ EORTC grade 1 or 2 (Grade 1: Fully functional status (i.e. able to work) with minor neurological findings, no medication needed; Grade 2: Neurological findings present sufficient to require home care / nursing assistance may be required / medications including steroids/anti-seizure agents may be required) (Cox, James D., et al "Toxicity criteria of the radiation therapy oncology group (RTOG) and the European organization for research and treatment of cancer (EORTC)." International Journal of Radiation Oncology• Biology• Physics 31.5 (1995): 1341-1346).
•8. Neurologically symptomatic patients must not require immediate surgical or radiation therapy for their symptoms, as decided by an investigator.
•9. Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
•10. Have adequate organ function, as determined by
+15 more criteria

Exclusion Criteria

•1. Patients who have received prior brigatinib therapy or other CNS-penetrant ALK TKIs, including alectinib, lorlatinib, or ceritinib.
•2. RTOG/EORTC Acute CNS symptoms, grade 3 and 4 (Grade 3: Neurological findings requiring hospitalization for initial management; Grade 4: Serious neurological impairment that includes paralysis, coma, or seizures \> 3 per week despite medication / hospitalization required).
•3. Currently pregnant, planning a pregnancy during the study period, or breastfeeding.
•4. Have clinically significant, uncontrolled cardiovascular disease per investigator, specifically including, but not restricted to:
•1. Myocardial infarction (MI) within 6 months prior to the first dose of study drug
•2. Unstable angina within 6 months prior to first dose of study drug
•3. Clinically significant congestive heart failure (CHF) within 6 months prior to first dose of study drug
•4. History of clinically significant atrial or ventricular arrhythmia (including clinically significant bradyarrhythmia), as determined by the treating physician
•5. Cerebrovascular accident or transient ischemic attack within 6 months prior to first dose of study drug
•5. Have uncontrolled hypertension per the investigator. Patients with persistent hypertension of systolic ≥140 or diastolic ≥90 mm Hg should be under treatment on study entry to control blood pressure.
+10 more criteria

Locations (3)

City of Hope

Duarte, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

November 17, 2020

Primary Completion Date

April 14, 2022

Completion Date

April 14, 2022

Last Updated

October 24, 2022

Enrollment

ACTUAL participants

Conditions

Brain MetastasesLung Cancer

Interventions

Brigatinib

DRUG

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Brigatinib Before Brain Irradiation Trial (B3i Trial)

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Magnetic Resonance Imaging of the Lung: Oncological Applications