Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III NSCLC
NCT06706219 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-04-03
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
Conditions
- Non Small Cell Lung Cancer (Stage III)
Interventions
- 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.
Sponsors & Collaborators
-
Hunan Province Tumor Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-10
- Primary Completion
- 2028-11-30
- Completion
- 2029-12-31
Countries
- China
Study Locations
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