🅇
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient.
Status
Recruiting
Phase
PHASE2
NCT ID
NCT05967689

Trial Summary

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.

Sponsor: Taiho Oncology, Inc.
Participants: ALL
Start: 2023-07-31
Completion: 2028-08-31
Min Age: 18 Years

Eligibility Criteria

Inclusion Criteria: 1. Written informed consent. 2. ≥18 years of age (or meets the country's regulatory definition of legal adult age, whichever is greater. 3. Pathologically confirmed, locally advanced or metastatic NSCLC meeting all the following criteria: Cohort A participants: * Documented EGFR ex20ins status, as determined by local testing performed at a Clinical Laboratory Improvement Amendments (CLIA) certified (United States [US]) or locally certified laboratory (outside the US). * Progressed on or after systemic therapy with an agent targeting ex20ins, either alone or in combination with standard platinum-based chemotherapy for the treatment of advanced disease. Participants who discontinued previous treatment due to unacceptable toxicity are eligible. i. Permitted prior ex20ins therapies include: amivantamab, sunvozertinib (DZD9008), and BLU451. Other prior ex20ins–directed treatment may be discussed with the Sponsor for eligibility assessment. * Participants with brain metastasis must be neurologically stable. Participants must have received central nervous system (CNS)-directed therapy and have no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the Screening Period. Additionally, they must be on a stable or decreasing dose of corticosteroids and/or anti-convulsant medications for…

Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.

Share: 𝕏 Twitter/X 🔗 LinkedIn View on Source ↗

More in Oncology