OncoMatch/Clinical Trials/NCT07128199
A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Versus Placebo in Early Stage NSCLC Patients With Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)
Is NCT07128199 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies TAS6417 for lung cancer.
Treatment: TAS6417 — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 20 insertion
exon20 insertion mutations (ex20ins)
Required: EGFR g719x
other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I) exons 18-21 of the EGFR tyrosine kinase domain
Required: EGFR l861q
other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I) exons 18-21 of the EGFR tyrosine kinase domain
Required: EGFR s768i
other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I) exons 18-21 of the EGFR tyrosine kinase domain
Disease stage
Required: Stage IB, IIA, IIB, IIIA, IIIB (N2 ONLY) (other)
Pathologic (post-operative) Stage IB, IIA, IIB, or IIIA according to the AJCC 9th tumor nodes metastasis (TNM) staging system for lung cancer. In addition, participants with stage IIIB are eligible when regional lymph node involvement is N2.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: EGFR inhibitor (zipalertinib, TAS6417, CLN-081)
Zipalertinib (TAS6417/CLN-081) or any other EGFR inhibitor at any time
Cannot have received: radiation therapy
Pre-operative or post-operative or planned radiation therapy for the current lung cancer
Cannot have received: systemic anticancer therapy for NSCLC
Exception: Participants who have received postoperative adjuvant platinum-based chemotherapy up to 4 cycles are permitted
Any prior systemic anticancer therapy for NSCLC, including preoperative (neoadjuvant) chemotherapy, immunotherapy, or investigational therapy. (Exception: Participants who have received postoperative adjuvant platinum-based chemotherapy up to 4 cycles are permitted)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Alaska Oncology and Hematology · Anchorage, Alaska
- City of Hope Comprehensive Cancer Center - Duarte · Duarte, California
- City of Hope Comprehensive Cancer Center Orange County Lennar Foundation Cancer Center · Irvine, California
- Scripps Clinic Torrey Pines · La Jolla, California
- Kaiser Permanente - Vallejo Medical Center · Vallejo, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07128199 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR inhibitor, radiation therapy, systemic anticancer therapy for NSCLC disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR exon 20 insertion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR g719x is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR l861q is a required biomarker for enrollment.
What disease stage is eligible?
Stage IB or IIA or IIB or IIIA or IIIB (N2 ONLY) is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages