At a glance
ClinicalIndex Comparison Record- ✓Age 18-75 years
- ✓Histologically or cytologically confirmed squamous cell lung cancer
- ✓Locally advanced or metastatic disease (stage IIIB-IV)
- ✓At least one measurable lesion by RECIST v1.1
- ✕Small cell lung cancer or mixed SCLC/NSCLC
- ✕Lung adenocarcinoma or mixed adenocarcinoma/squamous cell carcinoma
- ✕EGFR sensitive mutation, ALK fusion positive, or ROS1 fusion positive
- ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or T cell co-stimulatory drugs
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating low-dose radiation therapy and stereotactic body radiation therapy, chemotherapy, and 1 other intervention for Lung Squamous Cell Carcinoma. Currently recruiting, targeting 114 participants across 6 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Patients will receive radiation therapy.
Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).
Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).