RecruitingPhase 2NCT06121505

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

Sponsor

Sichuan University

Enrollment

114 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding low-dose whole-body radiation plus targeted radiation (SBRT) to a standard combination of immunotherapy and chemotherapy improves outcomes for people with advanced squamous cell lung cancer — a type of non-small cell lung cancer. **You may be eligible if...** - You are 18–75 years old - You have confirmed squamous cell lung cancer that is locally advanced or has spread and cannot be surgically removed - You have not received any prior treatment for this advanced-stage disease - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - Your lung cancer is small cell, adenocarcinoma, or a mix of cell types - Your tumor has a targetable EGFR, ALK, or ROS1 gene change - You have previously received immunotherapy (anti-PD-1/PD-L1 drugs) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONlow-dose radiation therapy and stereotactic body radiation therapy

Patients will receive radiation therapy.

DRUGchemotherapy

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).

DRUGSintilimab