Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer
Recruiting · NCT04973293 · Interventional (participants receive a specific treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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);
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Satisfactory preoperative laboratory testing and adequate pulmonary function for surgery;
- Patients approve and sign the informed consent.
Exclusion criteria
- Pancoast tumor, squamous cell carcinoma, large-cell carcinoma and sarcomatoid carcinoma;
- Patients with active autoimmune disease or history of autoimmune disease;
- Patients who have a condition requiring systemic treatment with either prednisone or other immunosuppressive medications;
- Patients with a history of symptomatic interstitial lung disease;
- History of allergy to study drug components;
- Women must not be pregnant or breast-feeding;
- Men with female partners that are not willing to use contraception;
- Patients who have received prior chemotherapy, anti-angiogenesis therapy and immunotherapy for this malignancy or for any other past malignancy;
- Patients who have received prior treatment for non-small cell lung cancer;
- Any mental or psychological condition which would not permit the patient to complete the study or understand the patient information;
- Patients who have major hemoptysis within the past 4 weeks, tumor has invasion or is close to great vessels;
- Patients with high risk of major bleeding;
- Patients who have arterial thrombotic events, esophageal varices, peptic ulcers, wounds or bone fractures;
- Patients who have prior malignancies;
- HIV, HBV, HCV infection or active pulmonary tuberculosis;
- 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 is running
1 location listed.
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine - Shanghai, Shanghai Municipality, China