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Clinical Trial ยท PHASE2 ยท Recruiting

A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

03 April 2026 NCT05967689 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE2
Participants
ALL
Age Range
18 Years+

About This Trial

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.

Who Can Join?

Inclusion Criteria: 1. Written informed consent. 2. โ‰ฅ18 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…

⚠ Always speak to your doctor before applying to any clinical trial.

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