A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment i… (NCT07128199) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection
United States360 participantsStarted 2025-12-22
Plain-language summary
The purpose of this study is to compare the efficacy of zipalertinib combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in participants with early stage (stage IB-IIIA) resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.
✓. Documented EGFRmt status as determined by local testing performed at a clinical laboratory improvement amendment (CLIA) certified (United States \[US\]) or accredited (outside of the US) local laboratory, defined as either one of the following EGFRmt:
✓. exon20 insertion mutations (ex20ins) or
✓. other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I)
✓. Baseline imaging assessment of the brain (MRI or CT scan) performed within 8 weeks prior to randomization must show no evidence of brain metastasis
✓. Complete surgical resection of the primary NSCLC is mandatory with negative surgical margins and systematic lymph node sampling or dissection.
✓. Complete recovery from surgery, including post-operative wound healing at the time of randomization. Randomization must occur between 4 weeks and 12 weeks following surgery.
✓. Eastern cooperative oncology group performance status (ECOG PS) of 0 or 1.
Exclusion criteria
✕. Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study.
✕. Treatment with any of the following within the time frame specified:
✕
What they're measuring
1
Disease-free Survival (DFS) as Assessed by the Investigator