NCT06706219

Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III NSCLC

Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III Non-small Cell Lung Cancer (NSCLC): a Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase 2 open-label, single-center clinical study to evaluate the efficacy and safety SKB264 in combination with toripalimab in patients with unresectable stage III non-small cell lung cancer

Detailed description

This study is a phase 2 open-label, single-center clinical study to evaluate the efficacy and safety SKB264 in combination with toripalimab in patients with unresectable stage III non-small cell lung cancer. The study includes a screening period (up to 28 days after the subject signs the informed consent form until before the first dose), a treatment period (including an induction treatment period, a local treatment period (surgery or radical radiotherapy), and a consolidation treatment period), and a follow-up period (including two parts of safety follow-up and survival follow-up). Approximately 50 patients with initially unresectable stage III non-small cell lung cancer patients, without EGFR/ALK/ROS-1-sensitive mutations, without chest radiotherapy and systemic anti-tumor therapy, were enrolled

Conditions

• Non Small Cell Lung Cancer (Stage III)

Interventions

Type	Name	Description
DRUG	Sacituzumab tirumotecan plus toripalimab	Participants meeting the inclusion criteria will receive toripalimab (240 mg, IV) + SKB264 (4mg/kg, IV) for 12 weeks as induction therapy. Patients who undergo surgical resection will receive toripalimab 240 mg intravenously every 3 weeks (Q3W) for up to 13 cycles. Patients who receive definitive concurrent chemoradiotherapy will receive toripalimab 240 mg intravenously every 3 weeks (Q3W) for a maximum duration of 1 year.

Timeline

• Start date: 2026-05-10
• Primary completion: 2028-11-30
• Completion: 2029-12-31
• First posted: 2024-11-26
• Last updated: 2026-04-03

Locations

1 site across 1 country: China