Combining low-dose radiation with immunotherapy and chemotherapy for lung cancer treatment
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
This study is testing if adding low-dose radiation to standard chemotherapy and a new immune treatment can help people with advanced lung cancer feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sichuan University Academic / other |
| Drugs / interventions | sintilimab, chemotherapy, radiation, immunotherapy |
| Locations | 6 sites (Chongqing, Chongqing Municipality and 5 other locations) |
| Trial ID | NCT06121505 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with untreated, locally advanced or metastatic squamous cell lung cancer.
Not a fit: Patients with small cell lung cancer or those with specific genetic mutations like EGFR or ALK may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced lung squamous cell carcinoma.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and radiation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Chongqing, Chongqing Municipality and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.