Status:
RECRUITING
Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer
Lead Sponsor:
Sichuan University
Collaborating Sponsors:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Lung Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old and ≤ 75 years old;
- Histologically or cytologically confirmed squamous cell lung cancer, imaging confirmed locally advanced or metastatic disease (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV);
- According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one imaging measurable lesion;
- Enough to provide quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression;
- Have not received any systemic anti-tumor treatment for locally advanced or metastatic disease in the past;
Exclusion
- The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；
- The pathology is lung adenocarcinoma, including lung cancer mixed with lung adenocarcinoma and lung squamous cell carcinoma;
- EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive;
- Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;
- Pregnant or lactating women;
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT06121505
Start Date
March 1 2024
End Date
February 28 2027
Last Update
December 17 2025
Active Locations (6)
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1
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
2
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
3
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hunan, China, 430022
4
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610044