Central Nervous System Efficacy of Capmatinib in NSCLC With Brain Metastases With cfDNA Positive MET Alterations

Non-small Cell Lung Cancer Clinical Trial

Official title: A Phase 2 Open-label Study to Determine the Central Nervous System Efficacy of Capmatinib in NSCLC Patients With Brain Metastases With cfDNA Positive MET Alterations

Status Withdrawn

Clinical Trial Summary

This is a phase II single-arm open label trial to evaluate the intracranial efficacy of capmatinib in advanced stage NSCLC with asymptomatic BM with positive MET amplification or METΔex14 detected on cfDNA.

Clinical Trial Description

This will be a phase II single-arm open label trial of capmatinib at a dose of 400 mg orally twice daily in advanced stage NSCLC with asymptomatic BM with positive MET amplification or METΔex14 detected on cfDNA. This trial will evaluate the intracranial efficacy of capmatinib in cfDNA MET amplification or mutation positive NSCLC. Potentially eligible patients will undergo prescreening with Predicine's cfDNA assay to identify cfDNA MET amplification or mutation positive NSCLC patients. Radiographic assessments for cranial and extracranial disease response will occur every 8 weeks. Capmatinib will be given until disease progression or intolerability of treatment. A two-stage single arm design will be used to establish whether the proportion of responses is sufficiently high to warrant further testing and to allow stopping for futility at the first stage. ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Non-small Cell Lung Cancer

• NCT number: NCT05567055
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 3, 2023
• Completion date: September 2028