OncoMatch/Clinical Trials/NCT07128199
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
Is NCT07128199 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Cisplatin and Carboplatin for nsclc, stage ib-iiia.
Treatment: Cisplatin · Carboplatin · Pemetrexed · TAS6417 — 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).
Check if I qualifyExtracted eligibility criteria
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)
Required: EGFR L861Q
other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I)
Required: EGFR S768I
other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I)
Disease stage
Required: Stage IB, IIA, IIB, IIIA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgical resection — curative
Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor.
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
Any prior systemic anticancer therapy (e.g., neoadjuvant chemotherapy), including investigational therapy, for treatment of NSCLC.
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
- Georgetown University School of Medicine · Washington D.C., District of Columbia
- D&H Cancer Research Center - Margate · Margate, Florida
- Alpha Oncology Research · Orange City, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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