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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06706219 on ClinicalTrials.gov