3.

PD-1/PD-L1抑制剂在NSCLC新辅助治中的临床研究（正在进行）

Ongoing clinical researches of PD-1/PD-L1 inhibitors in neoadjuvant therapy with NSCLC

NCT number	Phase	Arms	Key endpoints	Population
DFS: disease free survival; EFS: Event-free survival.
Pembrolizumab
NCT02987998	Ⅰ	Neoadjuvant pembrolizumab with chemoradiotherapy and adjuvant pembrolizumab	Safety, ORR, PFS, ORR, pCR, OS	20
NCT02938624	Ⅰ	Neoadjuvant pembrolizumab	Dose limiting toxicities	28
NCT03217071	Ⅱ	2 cycles of neoadjuvant pembrolizumab with SBRT	Change in number of infiltrating CD3+ T cells, OS	40
NCT02818920	Ⅱ	Two doses of neoadjuvant pembrolizumab and four doses of adjuvant nivolumab	Surgical feasibility, ORR, DFS, AE	32
NCT03197467	Ⅱ	2 cycles of neoadjuvant pembrolizumab	AE	30
NCT03425643	Ⅲ	4 cycles of neoadjuvant pembrolizumab and chemotherapy+adjuvant pembrolizumab	EFS, OS	786
Atezolizumab
NCT02994576	Ⅱ	Neoadjuvant atezolizumab	MPR	60
NCT03456063	Ⅲ	4 cycles of neoadjuvant atezolizumab+adjuvant atezolizumab	MPR, EFS, OR, pCR, MPR	302
Durvalumab
NCT03030131	Ⅱ	3 cycles of neoadjuvant durvalumab	Surgical resection R0, response rate, MPR	81
NCT02572843	Ⅱ	3 cycles of neoadjuvant cisplatin and docetaxel, followed by 2 cycles of durvalumab and adjuvant durvalumab	EFS, OS, OR, pCR, AE	68
Nivolumab+Ipilimumab
NCT02259621	Ⅱ	Neoadjuvant nivolumab±ipilimumab	Safety, feasibility, pathologic reponse, radiographic response	30
NCT02998528	Ⅰ-	Neoadjuvant nivolumab+ ipilimumab	EFS, pCR, OS, MPR	350
Durvalumab+Tremelimumab
NCT03237377	Ⅱ	2 cycles of neoadjuvant durvalumab+tremelimumab with radiotherapy	Safety, surgical mortality	32