Combining low-dose radiation with immunotherapy and chemotherapy for lung cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial investigates the effectiveness and safety of combining low-dose radiation therapy and stereotactic body radiation therapy with the PD-1 inhibitor sintilimab and standard chemotherapy in patients with locally advanced or metastatic squamous cell lung cancer. The trial involves 114 participants who will be randomly assigned to either the experimental group receiving the combination treatment or the control group receiving only sintilimab and chemotherapy. The goal is to determine if the addition of radiation therapy improves treatment outcomes compared to standard therapy alone. Participants will undergo treatment followed by maintenance therapy with sintilimab.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 75 years old;
2. 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);
3. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one imaging measurable lesion;
4. Enough to provide quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression;
5. Have not received any systemic anti-tumor treatment for locally advanced or metastatic disease in the past;

Exclusion Criteria:

1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；
2. The pathology is lung adenocarcinoma, including lung cancer mixed with lung adenocarcinoma and lung squamous cell carcinoma;
3. EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive;
4. 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;
5. Pregnant or lactating women;

Where it's running

• The Second Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Guizhou Provincial People's Hospital
  Guiyang, Guizhou, China Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hunan, China Recruiting
• Sichuan Cancer Hospital
  Chengdu, Sichuan, China Recruiting
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting
• Affiliated Hospital of North Sichuan Medical College
  Nanchong, Sichuan, China Recruiting

Study contacts

• Principal investigator: You Lu, MD — West China Hospital
• Study coordinator: Jianxin Xue, MD
• Email: killercell@163.com
• Phone: +86 189 8225 1798

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.