Combining sintilimab, bevacizumab, and chemotherapy for lung cancer treatment before surgery

The Safety and Feasibility of Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Locally Advanced Resectable Non-Small Cell Lung Cancer

This study is testing a new treatment that combines two medications and chemotherapy before surgery to see if it helps people with advanced lung cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone, bevacizumab, sintilimab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT04973293 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and feasibility of a new treatment approach for locally advanced and resectable non-small cell lung cancer (NSCLC). It involves administering sintilimab, an immune checkpoint inhibitor, combined with bevacizumab and chemotherapy before surgical resection. The study aims to enroll twenty patients with stage II-IIIA NSCLC and will evaluate the safety of this neoadjuvant treatment, along with its feasibility, radiological response, and rate of major pathological response. The trial is designed to improve the efficacy of current treatment standards for this type of lung cancer.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed, previously untreated, and surgically resectable non-small cell lung cancer at stage II-IIIA.

Not a fit: Patients with squamous cell carcinoma, large-cell carcinoma, or those with active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes for patients with locally advanced non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise with similar combinations of immunotherapy and chemotherapy in advanced lung cancer, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed, previously untreated and surgically resectable non-small cell lung cancer (stage II-IIIA, patients with squamous cell carcinoma or EGFR mutation should not be included);
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
3. Satisfactory preoperative laboratory testing and adequate pulmonary function for surgery;
4. Patients approve and sign the informed consent.

Exclusion Criteria:

1. Pancoast tumor, squamous cell carcinoma, large-cell carcinoma and sarcomatoid carcinoma;
2. Patients with active autoimmune disease or history of autoimmune disease;
3. Patients who have a condition requiring systemic treatment with either prednisone or other immunosuppressive medications;
4. Patients with a history of symptomatic interstitial lung disease;
5. History of allergy to study drug components;
6. Women must not be pregnant or breast-feeding;
7. Men with female partners that are not willing to use contraception;
8. Patients who have received prior chemotherapy, anti-angiogenesis therapy and immunotherapy for this malignancy or for any other past malignancy;
9. Patients who have received prior treatment for non-small cell lung cancer;
10. Any mental or psychological condition which would not permit the patient to complete the study or understand the patient information;
11. Patients who have major hemoptysis within the past 4 weeks, tumor has invasion or is close to great vessels;
12. Patients with high risk of major bleeding;
13. Patients who have arterial thrombotic events, esophageal varices, peptic ulcers, wounds or bone fractures;
14. Patients who have prior malignancies;
15. HIV, HBV, HCV infection or active pulmonary tuberculosis;
16. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Hecheng Li, MD, PhD — Ruijin Hospital
• Study coordinator: Hecheng Li, MD, PhD

Conditions Lung Neoplasm Malignant; Non-small cell lung cancer; Neoadjuvant therapy; Immunotherapy