drugset / Trial / NCT04926831

Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC

NCT04926831

Phase 2 Terminated 4 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study was planned to determine if neoadjuvant capmatinib could improve the major pathological response (MPR) in patients with Stage IB-IIIA, N2 and selected IIIB (T3N2 or T4N2) lung cancers with Mesenchymal Epithelial Transition (MET) exon 14 mutations and/or high MET amplification beyond those achieved with surgery, chemotherapy, and radiation. Treatment was to be continued with capmatinib in the adjuvant setting to evaluate the potential clinical benefit of extended therapy. The purpose of this study is to determine if neoadjuvant capmatinib can improve outcomes in participants with stages I-IIIA non-small cell lung cancer with MET exon 14 mutations and/or high MET amplification beyond those achieved with surgery, chemotherapy, and radiation.

Timeline

Start
2022-08-10
Primary completion
2024-03-13
Completion
2024-03-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Capmatinib Small molecule 400 mg Oral