Clinical Development Programme
Besides the ongoing clinical trials that have supported the EMA and FDA registration of entrectinib (ALKA-372-001, STARTRK-1, STARTRK-2, STARTRK-NG), another trial in which entrectinib is available is the B-FAST trial. A Phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays. Entrectinib is also included in the TAPISTRY global, multicenter, basket trial too.
Key Ongoing Entrectinib Clinical Trials
Registry Number |
Name |
Phase |
Title |
|
EudraCT 2017-000076-28 NCT03178552 |
B-FAST: Blood-First Assay Screening Trial |
2/3 |
A study to evaluate efficacy and safety of multiple targeted Therapies as treatments for participants with non-small cell lung cancer (NSCLC) |
NCT04589845 |
TAPISTRY |
2 |
An open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. |
(Source https://clinicaltrials.gov)