Clinical Trial

Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer

Recruiting Phase 2
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Summary
This is a randomized, controlled, open-label, multicenter phase II clinical trial comparing the efficacy and safety of low-dose radiation therapy and stereotactic body radiation therapy combined with PD-1 inhibitor (sintilimab) and standard platinum-based doublet chemotherapy versus PD-1 inhibitor (sintilimab) combined with standard platinum-based doublet chemotherapy as first-line treatment in patients with locally advanced or metastatic squamous cell lung cancer. There will be 57 subjects in the experimental group and 57 subjects in the control group, with a total of 114 subjects.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-11-07; most recent amendment 2025-12-09.
Status change: Not Yet Recruiting → Recruiting 2024-04-15
Trial Details
NCT Number NCT06121505
Lead Sponsor Sichuan University
Collaborators: Innovent Biologics (Suzhou) Co. Ltd.
Conditions Lung Squamous Cell Carcinoma
Enrollment 114 participants
Start Date 2024-03-01
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-12-17