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 States, Argentina, Australia360 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease-free Survival (DFS) as Assessed by the Investigator
. 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:
. Zipalertinib (TAS6417/CLN-081) or any other EGFR inhibitor at any time.
. Pre-operative or post-operative or planned radiation therapy for the current lung cancer.
. Any prior systemic anticancer therapy (e.g., neoadjuvant chemotherapy), including investigational therapy, for treatment of NSCLC.
. Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
. Treatment with an investigational drug within five half-lives of the compound or any of its related material, if known.
. Has received only wedge resections (complete anatomic segmentectomy is acceptable).