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NCT07128199 · ClinicalTrials.gov registry record · Phase 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

A Phase 3 study of Lung Cancer and EGFR, sponsored by Taiho Oncology.

Recruiting
Registry status
Phase 3
Development phase
360
Enrollment target
20
Study locations

NCT07128199 is a Phase 3 study of Lung Cancer and EGFR that is actively recruiting participants, run by Taiho Oncology. The registered enrollment target is 360 participants, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT07128199, a Phase 3 study of Lung Cancer and EGFR, is actively recruiting participants, sponsored by Taiho Oncology.

RECRUITING
Registry status
Phase 3
Development phase
360 participants
Enrollment target
20
Study locations

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).

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

FieldValue
Enrollment Target 360 participants
Start Date 2025-12-22
Est. Completion 2032-10-01
Phase Phase 3

Sponsor

Taiho Oncology

52 total trials

What the Registry Record Tells You About NCT07128199

The ClinicalTrials.gov registry entry for NCT07128199 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (61% lower). The listed sponsor is Taiho Oncology, which has 52 total studies on file at ClinicalTrials.gov.

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.

NCT07128199 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Buenos Aires, Florida, Michigan.

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.

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).

Who is sponsoring clinical trial NCT07128199?

This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.