Trials / Recruiting
RecruitingNCT07128199
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 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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- Taiho Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This study will evaluate zipalertinib, a novel EGFR tyrosine kinase inhibitor (TKI) in combination with standard platinum-based adjuvant chemotherapy versus placebo in combination with chemotherapy in participants with resected stage IB-IIIA NSCLC harboring uncommon EGFRmt. Approximately 360 participants will be randomized to: Arm A: Platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed) in combination with zipalertinib twice daily (BID), followed by zipalertinib alone OR Arm B: Platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed) in combination with placebo BID, followed by placebo BID alone. An independent data monitoring committee (IDMC) will be established to monitor interim safety data.
Conditions
- NSCLC, Stage IB-IIIA
- Lung Cancer
- Adjuvant
- Post-surgical
- EGFR
- Exon 20
- Early Stage Lung Cancer
- Uncommon EGFR Mutations
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cisplatin | IV infusion. |
| DRUG | Carboplatin | IV infusion. |
| DRUG | Pemetrexed | IV infusion. |
| DRUG | TAS6417 | Oral tablets. |
| DRUG | Zipalertinib Matching-placebo | Oral tablets. |
Timeline
- Start date
- 2025-12-22
- Primary completion
- 2029-10-01
- Completion
- 2032-10-01
- First posted
- 2025-08-17
- Last updated
- 2026-04-07
Locations
253 sites across 24 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07128199. Inclusion in this directory is not an endorsement.