NCT07438600

Study of Sacituzumab Tirumotecan Combined With Toripalimab for Resectable Stage II-IIIB NSCLC

A Single-center, Phase II Clinical Study of Sacituzumab Tirumotecan Combined With Toripalimab as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of neoadjuvant therapy of sacituzumab tirumotecan combined with toripalimab.

Conditions

• NSCLC (Non-small Cell Lung Cancer)

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan (SG)+Toripalimab	1. Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg via intravenous infusion, with a treatment cycle of every 2 weeks, on Day 1 of each cycle. 2. Toripalimab will be administered at a dose of 240 mg via intravenous infusion, with a treatment cycle of every 3 weeks, on Day 1 of each cycle.

Timeline

• Start date: 2026-02-24
• Primary completion: 2027-02-28
• Completion: 2028-02-28
• First posted: 2026-02-27
• Last updated: 2026-03-27