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About
This is a randomized, open label study designed to evaluate the efficacy and safety of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA-N2 non-small cell lung cancer.
Full description
This is an open-label, randomised, two-arm, phase II, multi-centre clinical trial. The proposed study will evaluate the efficacy and safety of preoperative administration PD-1 antibody plus chemotherapy in patients resectable stage IIIA-N2 NSCLC. Data obtained in this study will provide valuable information for planning further phase III clinical trials of anti-PD-1 and other immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Written informed consent provided.
Males or females aged ≥18 years.
Pathologically diagnosed of non-small cell lung cancer.
Diagnosed as stage IIIA- N2.The diagnosis standard of N2 is as below: Pts with resectable stage IIIA-N2 NSCLC confirmed by mediastinoscopy or EBUS and PET/CT.
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 randomization.
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).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
93 participants in 2 patient groups
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Central trial contact
Junqi Wu, MD; Chang Chen, MD, PhD
Data sourced from clinicaltrials.gov
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