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Active (not recruiting) Phase 3 2025-521775-31-00

A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients with Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)

Phase 3 – large-scale trial before approval
Conditions: Stage IB-IIIA NSCLC Patients with uncommon EGFR Mutations

Sponsor: Taiho Oncology Inc.

trial.available_in: БГ
Overview
Trial status: Authorised Disease-free survival (DFS) by investigator assessment
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 141 participants
Interventions
Zipalertinib Placebo Tablets is a film-coated tablet that does not contain the active ingredient, zipalertinib.
Drug
Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Drug
Zipalertinib
Drug
Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
Drug
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Drug
Locations 9
Belgium (1)
France (1)
Germany (1)
Greece (1)
Italy (1)
Netherlands (1)
Poland (1)
Romania (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.10.2025
Registry ID
2025-521775-31-00
Source
euclinicaltrials.eu
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