NCT06121505RecruitingPhase 2
Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer
Low-dose Radiation Therapy and Stereotactic Body Radiation Therapy Combined With PD-1 Inhibitor Sintilimab and Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Patients With Locally Advanced or Metastatic Squamous Cell Lung Cancer: A Randomized, Phase II Multicenter Clinical Trial
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 31 Oct 2023
- Start date
- 1 Mar 2024
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Sichuan University
- Diseases
- Lung cancer
- NCT number
- NCT06121505
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 114
- From 1 Mar 2024 to the primary completion date, 28 Feb 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
Lab values
- EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive;
Other
- Pregnant or lactating women;
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Guizhou Provincial People's Hospital Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| Affiliated Hospital of North Sichuan Medical College Coordinator of this site? Confirm its status | Nanchong | China | Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.