NCT07274761

Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation.

A Phase II, Single-arm, Single-center Study of Neoadjuvant Sunvozertinib for Stage II-IIIB Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of sunvozertinib as neoadjuvant therapy in patients with stage II-IIIB non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins).

Conditions

• Potentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung Cancer
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sunvozertinib	Participants will receive oral administration of sunvozertinib 300 mg QD, with each treatment cycle defined as 28 days, until meeting any treatment discontinuation criteria.

Timeline

• Start date: 2024-10-17
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2025-12-10
• Last updated: 2025-12-10

Locations

1 site across 1 country: China