A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Taiho Oncology, Inc.
Study ID
NCT07128199
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TAS6417 — DRUG
    Oral tablets.
  • Zipalertinib Matching-placebo — DRUG
    Oral tablets.

Study Details

The purpose of this study is to compare the efficacy of zipalertinib versus placebo in participants with early stage resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).

Key Dates

First listed
Aug 17, 2025
Start date
Dec 22, 2025
Status verified
Oct 2026
Primary completion
Oct 1, 2029
Completion
Oct 1, 2032

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Zipalertinib
    Participants will receive zipalertinib orally until the participant meets any of the treatment discontinuation criteria.
  • Placebo Comparator: Placebo
    Participants will receive zipalertinib matching-placebo, until the participant meets any of the treatment discontinuation criteria.

Primary Outcome Measure

Disease-free Survival (DFS) as Assessed by the Investigator [ Time Frame: Up to 5 years ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
Alaska Oncology and HematologyAnchorageAlaska99508-
City of Hope Comprehensive Cancer Center - DuarteDuarteCalifornia91010-
City of Hope Comprehensive Cancer Center Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
Scripps Clinic Torrey PinesLa JollaCalifornia92037-
Kaiser Permanente - Vallejo Medical CenterVallejoCalifornia94589-
Georgetown University School of MedicineWashington D.C.District of Columbia20007-
D&H Cancer Research Center - MargateMargateFlorida33063-
Alpha Oncology ResearchOrange CityFlorida32763-
City of Hope - AtlantaNewnanGeorgia30265-
University of Illinois Medical CenterChicagoIllinois60612-
Profound Research LLC at Michigan Hematology and Oncology ConsultantsDearbornMichigan48126-
Henry Ford Health SystemDetroitMichigan48202-
Memorial Sloan Kettering Cancer Center - Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering Cancer Center - MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering Cancer Center - BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering Cancer Center - CommackCommackNew York11725-
Memorial Sloan Kettering Cancer Center - WestchesterEast White PlainsNew York10604-
Long Island Jewish Medical CenterLake SuccessNew York11042-
Memorial Sloan Kettering Cancer Center - New YorkNew YorkNew York10065-
Perlmutter Cancer Center - 34th StreetNew YorkNew York10016-
Memorial Sloan Kettering Cancer Center - NassauUniondaleNew York11553-
Atrium Health Wake Forest Baptist - Comprehensive Cancer CenterCharlotteNorth Carolina28204-
Durham Veterans Affairs Health Care SystemDurhamNorth Carolina27705-
Gabrail Cancer and Research CenterCantonOhio44718-
Gibbs Cancer Center and Research Institute SpartanburgSpartanburgSouth Carolina29303-
Virginia Cancer Specialists - Arlington OfficeArlingtonVirginia22201-
Virginia Cancer Specialists - Fairfax OfficeFairfaxVirginia22031-
Virginia Cancer Specialists - Bristow OfficeManassasVirginia20110-
Virginia Cancer Specialists - RestonRestonVirginia20190-
Virginia Cancer Specialists - Woodbridge OfficeWoodbridgeVirginia22191-

Find similar trials in Anchorage, AK

Nationwide
Lung cancer trialsOncology trialsLung oncology trialsLung disease trials
By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Alaska Oncology and Hematology· Anchorage, AKCity of Hope Comprehensive Cancer Center - Duarte· Duarte, CACity of Hope Comprehensive Cancer Center Orange County Lennar Foundation Cancer Center· Irvine, CAScripps Clinic Torrey Pines· La Jolla, CAKaiser Permanente - Vallejo Medical Center· Vallejo, CAGeorgetown University School of Medicine· Washington D.C., DC

Related Studies