REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

Phase 3 Active not recruiting 285 enrolled Taiho Oncology, Inc.

RandomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.

Timeline

Start: 2023-12-18
Primary completion: 2026-10-29
Completion: 2027-05-27

Publications

Heymach JV, Yu HA, Besse B, Cheng Y, Tan DS, Wei L, Wacheck V, Nishio M. REZILIENT3: randomized phase III study of first-line zipalertinib plus chemotherapy in patients with EGFR exon 20 insertion-mutated NSCLC. Future Oncol. 2025 Feb;21(5):549-556. doi: 10.1080/14796694.2025.2457294. Epub 2025 Feb 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CLN-081	Small molecule	—	Oral

Indications

No indication recorded.