NCT07281209

A Study of SHR-A1811 Combined With Adebelimumab as Neoadjuvant Therapy for Resectable HER2-Altered Non-Small Cell Lung Cancer

A Single-Arm Phase II Clinical Study of SHR-A1811 Combined With Adebelimumab as Neoadjuvant Therapy for Resectable HER2-Altered Non-Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multi-center Phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with SHR-A1811 in combination with Adebelimumab in patients with resectable, early-stage non-small cell lung cancer (NSCLC) harboring HER2 alterations.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	SHR-A1811 + Adebrelimab	This study evaluates a novel, chemotherapy-free neoadjuvant regimen uniquely combining the HER2-targeting ADC SHR-A1811 with the anti-PD-L1 antibody Adebrelimab. This specific combination of a HER2-ADC and an immune checkpoint inhibitor in the pre-operative setting for HER2-altered NSCLC is the primary feature distinguishing this intervention.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-01
• Completion: 2029-06-01
• First posted: 2025-12-15
• Last updated: 2025-12-15