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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
NCT07128199 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG TAS6417
- DRUG Zipalertinib Matching-placebo
Study Locations (20)
Buenos Aires
- Instituto Argentino de Diagnóstico y Tratamiento — Ciudad Autónoma de Buenos Aires
- Centro de Investigación Pergamino SA — Pergamino
- Hospital Universitario Austral — Pilar
Florida
- D&H Cancer Research Center - Margate — Margate
- Alpha Oncology Research — Orange City
Michigan
- Profound Research LLC at Michigan Hematology and Oncology Consultants — Dearborn
- Henry Ford Health System — Detroit
New York
- Perlmutter Cancer Center - 34th Street — New York
- Memorial Sloan Kettering Cancer Center - New York — New York
New South Wales
- Bankstown-Lidcombe Hospital — Bankstown
- GenesisCare - North Shore — St Leonards
Alaska
- Alaska Oncology and Hematology — Anchorage
California
- City of Hope Comprehensive Cancer Center - Duarte — Duarte
District of Columbia
- Georgetown University School of Medicine — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2025-12-22 |
| Est. Completion | 2032-10-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07128199
The ClinicalTrials.gov registry entry for NCT07128199 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 46 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07128199 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Buenos Aires, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07128199 about?
NCT07128199 is a clinical study titled "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". 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...
What is the current status of trial NCT07128199?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2025-12-22. Estimated completion is 2032-10-01.
What conditions does trial NCT07128199 study?
This clinical trial studies the following conditions: Lung Cancer, EGFR, NSCLC, Stage IB-IIIA, Adjuvant, Post-surgical. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07128199?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), TAS6417 (DRUG), Zipalertinib Matching-placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07128199?
This trial is sponsored by Taiho Oncology, which has 46 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07128199 being conducted?
This trial has 20 study locations across Alaska, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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