18 and older, any sex, with Brain Metastases or Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Meet Disease Control Rate (DCR) Criteria of Brain Metastases at 3 MonthsPrimary· 13-week MRI ±7 days
DCR is defined as complete response (CR), partial response (PR), or stable disease (SD) as defined by the RANO-BM (Response Assessment in Neuro-Oncology Criteria - Brain Metastases) criteria.
Group
Value
95% CI
Patients With ALK+ NSCLC and Brain Metastases
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 13 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06813079 — Using Tumor Models to Determine Treatments
· Phase 2
· not yet recruiting
NCT06522360 — Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightS
· Phase 2
· withdrawn
NCT06532149 — ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
· recruiting
NCT05718297 — Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer
· Phase 2
· withdrawn
NCT05721950 — A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cance
· active not recruiting
Other recruiting trials for Brain Metastases
Currently open trials in the same condition.
NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers
· recruiting
NCT07481786 — Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases
· Phase 3
· recruiting
NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer
· active not recruiting
NCT07053033 — Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR Be
· Phase 2
· recruiting
Other University of Colorado, Denver trials
Trials by the same sponsor.
NCT07292285 — The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial.
· not yet recruiting
NCT07021937 — Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity
· Phase 3
· not yet recruiting
NCT07453732 — Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients.
· NA
· not yet recruiting
NCT07038278 — 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma
· EARLY_PHASE1
· not yet recruiting
NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes
· Phase 2
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
Last refreshed: 24 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04634110.