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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Neoadjuvant treatment (durvalumab+carboplatin+nab-paclitaxel + anlotinib) will start within 1-3 days from enrollment. 2 cycles will be administered at 21-day (+/- 3 days) intervals (QW3). Then, two cycles of combined durvalumab and anlotinib (QW3) will be administered prior to surgery. Before surgery, a tumor assessment will be done. Patients with stable disease or partial response may be considered for surgery. Surgery: Surgery must be done within the 5rd-7th week from day 1 cycle 4 of neoadjuvant treatment (day 35-49 after day 1 of cycle 4). Adjuvant treatment: Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 2rd to 8th week from surgery. Twelve cycles of durvalumab adjuvant treatment (Q4W) will be administered.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPFS 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 60 months
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