Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2023-07-20
• Target enrollment: 0
• Participant gender: All

Summary

Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Drugs targeting PD-1/PD-L1 pathway have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents targeting VEGF (bevacizumab) has also been used for the first line treatment of advanced or metastatic NSCLC. Therefore, we conduct this single-arm clinical trial, which aims to investigate the safety and feasibility of neoadjuvant sintilimab combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Bevacizumab

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.