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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Taiho Oncology

52 total trials

What NCT07128199 shows while recruiting

NCT07128199 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (61% lower).

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 names 20 study sites across 14 states, led by 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.

Similar trials for Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07128199's enrollment target sits among peer trials

360 87th of 409 higher than 322 of 409 other Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07128199, the US trial registry maintained by the National Library of Medicine. NCT07128199 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.