OncoMatch/Clinical Trials/NCT07182682
A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery
Is NCT07182682 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies sunvozertinib for non-small cell lung cancer.
Treatment: sunvozertinib — To assess the efficacy and safety of sunvozertinib versus placebo as adjuvant therapy in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) or P-loop and αC-helix compression (PACC) mutations, who have had radical surgery, regardless of adjuvant chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 20 insertion
documented EGFR exon20ins (Cohort 1)
Required: EGFR PACC mutation
documented EGFR PACC mutations (Cohort 2). Common EGFR PACC mutations include, but not limited to, L718Q, G719X, S768I, L747P/S, V769L, E709_T710delinsD, L792H, and T854I.
Excluded: EGFR L858R
Concurrent EGFR sensitizing mutations (L858R and/or exon 19 deletion) ... should be excluded
Excluded: EGFR exon 19 deletion
Concurrent EGFR sensitizing mutations (L858R and/or exon 19 deletion) ... should be excluded
Excluded: ALK fusion
other driver gene variations with available standard therapies (e.g., ALK positive)
Disease stage
Required: Stage IB, II, IIIA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: EGFR tyrosine kinase inhibitor
Participants who have received any EGFR TKIs as (neo)adjuvant therapy for NSCLC
Cannot have received: radiation therapy
Participants who have received any preoperative or postoperative radiotherapy for NSCLC, or who plan to have radiotherapy during the study
Lab requirements
Blood counts
Adequate bone marrow reservation within 7 days prior to randomization
Kidney function
Adequate organ functions within 7 days prior to randomization
Liver function
Adequate organ functions within 7 days prior to randomization
Cardiac function
No mean resting QTc > 470 msec on 3 ECGs at screening; no significant ECG abnormalities; no factors increasing risk of QTc prolongation; no prior history of atrial fibrillation within 6 months (except drug-related and recovered)
Adequate bone marrow reservation or organ functions within 7 days prior to randomization. Cardiac criteria: mean resting QTc > 470 msec on 3 ECGs at screening, significant ECG abnormalities, risk factors for QTc prolongation, recent atrial fibrillation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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 qualify