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

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: lihecheng2000@hotmail.com
• Phone: 0086-021-64370045

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• Intensified versus conversion therapy for advanced liver cancer after first-line bevacizumab plus sintilimab fails

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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.