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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
(IV, Q3W)
Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel (Squamous NSCLC) (IV, Q3W)
(IV, Q3W)
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Changzheng Hospital
Shanghai, Shanghai Municipality, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
PFS at 24 months
The PFS is defined as the time from diagnosis to relapse, progression or death, whichever occurred first.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shuguang Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospita
Hangzhou, Zhejiang, China