Neoadjuvant Durvalumab/Anlotinib /Chemotherapy Plus Curative Resection in Stage III Non-Small-Cell Lung Cancer : A Single-arm Phase II Study
This is a randomized, open label study designed to evaluate the efficacy and safety of neoadjuvant Durvalumab/Anlotinib/Chemotherapy followed by surgery in resectable stage III non-small cell lung cancer.
• Written informed consent provided.
• Males or females aged ≥18 years.
• Pathologically diagnosed of non-small cell lung cancer.
• Diagnosed as stage III.
• Tumor should be considered resectable before study entry by a multidisciplinary team.
• ECOG (Performance status) 0-1.
• Screening laboratory values must meet the following criteria and should be obtained within 7 days prior to treatment.
• i. Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 x×109/L iii. Hemoglobin \> 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min v. AST/ALT ≤ 3 x ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) vii. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters or \>40% predicted value viii. INR/APTT within normal limits.
• Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before randomization.
• All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs.
• Patient capable of proper therapeutic compliance and accessible for correct follow-up.
• Measurable or evaluable disease (according to RECIST 1.1 criteria).