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

Launched by SICHUAN UNIVERSITY · Nov 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced or metastatic squamous cell lung cancer, a type of lung cancer that can be difficult to treat. Researchers want to see if combining low-dose radiation and a specific type of radiation therapy called stereotactic body radiation therapy (SBRT) with a medication called sintilimab (which helps the immune system fight cancer) and standard chemotherapy is more effective than using sintilimab and chemotherapy alone. The trial will involve 114 participants, split evenly between the two treatment groups.

To be eligible for this trial, participants need to be between 18 and 75 years old and have been diagnosed with squamous cell lung cancer that cannot be removed with surgery. They should also have measurable disease confirmed by imaging tests and not have received any prior treatments for their cancer. Participants can expect to receive close monitoring and care throughout the trial, while contributing to the understanding of how these treatments work together. It's important to note that individuals with certain types of lung cancer or specific prior treatments will not be eligible to participate.

Gender

ALL

Eligibility criteria

• 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;