Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer
Recruiting · NCT06121505 · Interventional (participants receive a specific treatment) · Lead sponsor: Sichuan University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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;
Where it is running
6 locations listed.
- The Second Affiliated Hospital of Chongqing Medical University - Chongqing, Chongqing Municipality, China
- Guizhou Provincial People's Hospital - Guiyang, Guizhou, China
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hunan, China
- Sichuan Cancer Hospital - Chengdu, Sichuan, China
- West China Hospital of Sichuan University - Chengdu, Sichuan, China
- Affiliated Hospital of North Sichuan Medical College - Nanchong, Sichuan, China