NCT07108816

A Single-center, Phase II Clinical Trial Evaluating the Efficacy of Sacituzumab Tirumotecan in Combination With Tagitanlimab as Neoadjuvant Therapy for PD-L1-positive, Resectable Stage II to IIIB Non-small Cell Lung Cancer (NSCLC)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In recent years, substantial progress has been made in the development of perioperative immunotherapy for non-small cell lung cancer (NSCLC). Accumulating evidence indicates that both neoadjuvant and adjuvant immunotherapy can significantly enhance key clinical endpoints, including pathological response rate, event-free survival (EFS), and disease-free survival (DFS), particularly in patients with stage II-III NSCLC. However, in the subset of patients with resectable stage II-IIIB NSCLC, the pathological complete response (pCR) rate following neoadjuvant immunotherapy remains modest at approximately 17-25%, underscoring the need for more effective therapeutic strategies and novel combination regimens. TROP2-targeted antibody-drug conjugates (TROP2-ADCs) have demonstrated promising antitumor activity and a manageable safety profile in patients with previously treated advanced NSCLC. Furthermore, the combination of Sacituzumab tirumotecan and tagitanlimab has shown robust efficacy in the first-line treatment of PD-L1-positive (tumor proportion score \[TPS\] ≥ 1%), driver gene-negative advanced NSCLC, with an objective response rate (ORR) exceeding 80%. Based on these encouraging data, we designed this study to evaluate the efficacy and safety of Sacituzumab tirumotecan in combination with tagitanlimab as neoadjuvant therapy in patients with PD-L1-positive (TPS ≥ 1%), resectable stage II-IIIB NSCLC.

Conditions

• Resectable Stage II-IIIB NSCLC

Interventions

Type	Name	Description
DRUG	Neoadjuvant Sacituzumab tirumotecan + tagitanlimab Followed by adjuvant tagitanlimab	Patients will receive 4 cycles of neoadjuvant treatment with preoperative Sacituzumab tirumotecan in combination with tagitanlimab, followed by surgery. After surgery, patients will receive up to 13 cycles of adjuvant tagitanlimab.

Timeline

• Start date: 2025-08-15
• Primary completion: 2026-12-30
• Completion: 2028-08-30
• First posted: 2025-08-07
• Last updated: 2025-08-07