Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer

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.

Trial Details

NCT ID
NCT06121505
Phase
PHASE2
Sponsor
Sichuan University
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • low-dose radiation therapy and stereotactic body radiation therapy
  • chemotherapy
  • Sintilimab
Locations (sample)
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Guiyang, Guizhou, China|26.58333,106.71667
  • Wuhan, Hunan, China
  • Chengdu, Sichuan, China|30.66667,104.06667
  • Chengdu, Sichuan, China|30.66667,104.06667

Key Eligibility 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 …
  • 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;

For full eligibility, visit ClinicalTrials.gov.

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