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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-05-05

No results posted yet for this 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

  • NSCLC, Stage IB-IIIA
  • Lung Cancer
  • Adjuvant
  • Post-surgical
  • EGFR
  • Exon 20
  • Early Stage Lung Cancer
  • Uncommon EGFR Mutations

Interventions

DRUG

Cisplatin

IV infusion.

DRUG

Carboplatin

IV infusion.

DRUG

Pemetrexed

IV infusion.

DRUG

TAS6417

Oral tablets.

DRUG

Zipalertinib Matching-placebo

Oral tablets.

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2029-10-01
Completion
2032-10-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Greece
  • Hong Kong
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Romania
  • Singapore
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128199 on ClinicalTrials.gov