Actively Recruiting
Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer
Led by Sichuan University · Updated on 2025-12-17
114
Participants Needed
6
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Sichuan University
Lead Sponsor
I
Innovent Biologics (Suzhou) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and 75 years or younger
- Histologically or cytologically confirmed squamous cell lung cancer with locally advanced or metastatic disease (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV)
- At least one measurable lesion on imaging according to RECIST v1.1
- Availability of quality-controlled tumor tissue or cell wax blocks to test PD-L1 expression
- No prior systemic anti-tumor treatment for locally advanced or metastatic disease
You will not qualify if you...
- Diagnosis of small cell lung cancer (SCLC) or mixed SCLC and non-small cell lung cancer (NSCLC)
- Diagnosis of lung adenocarcinoma or mixed lung adenocarcinoma and squamous cell carcinoma
- Presence of EGFR gene sensitive mutation, ALK fusion positive, or ROS1 fusion positive
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 drugs, or other drugs stimulating or inhibiting T cell receptors
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Actively Recruiting
2
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Actively Recruiting
3
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hunan, China, 430022
Actively Recruiting
4
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610044
Actively Recruiting
5
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610044
Actively Recruiting
6
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China, 637503
Actively Recruiting
Research Team
J
Jianxin Xue, MD
CONTACT
Y
You Lu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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