This is a multicenter, randomized, open label, phase II study.
This is a multicenter, randomized, open label, phase II study assessing the efficacy and safety of penpulimab plus chemotherapy or penpulimab plus anlotinib or penpulimab plus chemotherapy and anlotinib as neoadjuvant/adjuvant treatment in patients with resectable locally advanced non-small cell lung cancer. Eligible patients will be randomized to receive either penpulimab (200mg, iv, Q3W) plus chemotherapy (platinum based chemotherapy) or penpulimab (200mg, iv, Q3W) plus anlotinib (12mg, po, day 1-14, Q3W) or penpulimab (200mg, iv, Q3W) plus chemotherapy (platinum based chemotherapy) and anlotinib (12mg, po, day 1-14, Q3W) in a 1:1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
A cycle of treatment is defined as 21 days of once daily treatment.
A cycle of treatment is defined as 21 days of once daily treatment.
A cycle of treatment is defined as 21 days of once daily treatment.
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Major pathological response (MPR)
Time frame: About 3-6 weeks following completion of surgery.
Objective response rate (ORR)
Time frame: Within 7 days before surgery.
1 year Event-Free Survival rate
Time frame: Up to 5 Years from randomization
Event-Free Survival (EFS)
Time frame: Up to 5 years from randomization.
Overall survival (OS)
Time frame: Up to 5 years from randomization.
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Time frame: Up to 5 Years from randomization
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