表 1.

正在进行的NSCLC新辅助免疫相关临床研究

Ongoing trials of neoadjuvant immune-related therapy for NSCLC

	NCT		Regimen	Primary endpoint	Stage	n	Estimated completion date	Phase
Data updated to November 1, 2020. RT: radiation therapy; ICI: immune checkpoint inhibitor; S: surgery; CT: chemotherapy; NAC: neoadjuvant chemotherapy; MPR: major pathologic response; DFS: diease-free survival; pCR: pathologic complete response; EFS: event-free survival; TIL: tumor infiltrating lymphocyte; OS: overall survival; NSCLC: non-small cell lung cancer; SUV: standard uptake value; RCT: randomized controlled trial; RFS: relapse-free survival; TMB: tumor mutation burden; NA: not available; EGFR: epidermal growth factor receptor.
Neoadjuvant ICI monotherapy	NCT04047186		Nivolumab+S	MPR	Muti-GGO	50	2024/12	2
	NCT03732664		Nivolumab/Pembrolizumab+S	Feasibility and saftey	High-risk resectable NSCLC	40	2027/10	1
	NCT02818920	TOP1501	Pembrolizumab+S+Pembrolizumab	Feasibility and saftey	Ib-Ⅲa	30	2026/3	2
	NCT02938624	MK3475-223	Pembrolizumab+S	Feasibility and saftey	Ⅰ-Ⅱ	28	2021/4	1
	NCT03197467	NEOMUN	Pembrolizumab+S	Feasibility and saftey	Ⅱ-Ⅲa	30	2023/10	2
	NCT02994576	PRINCEPS	Atezolizumab+S	Feasibility and saftey	Ib-Ⅲa	60	2022/12	2
	NCT03030131	IONESCO	Durvalumab+S	Surgical resection	Ib-Ⅲb	81	2019/8	2
	NCT04371796		Sintilimab+S	MPR	Ⅱ-Ⅲa	20	2021/12	2
	NCT04197076		ICI*2+S	DFS, pCR	Ⅲa	200	2021/5
	NCT03853187	DONAN	Durvalumab+S+RT/CT	Feasibility and saftey	Ⅲ	20	2022/4	2
Neoadjuvant ICI combine with chemotherapy	NCT04541251	TOP-LC1210	(Camrelizumab+CT)*3	MPR	Ib-Ⅲa	40	2023/9	2
	NCT04144608		(Toripalimab+CT)+S	Surgical resection	Ⅲa or Ⅲb	30	2020/12	2
	NCT04304248	NeoTPD01	(Toripalimab+CT)*3	pCR	Ⅲ	30	2026/7	2
	NCT04586465	DYNAPET	(Pembrolizumab+CT)*3	MPR、SUV	IIa-Ⅲb	23	2022/6	2
	NCT04379739		Camrelizumab+CT	MPR	Ⅱ-Ⅲa	82	2026/12	2
			Camrelizumab+Apatinib
Neoadjuvant and adjuvant ICI	NCT04512430		(Atezolizumab+Bevacizumab+CT)+S+ (Atezolizumab q4w*6 mon)	MPR	Ⅲa (EGFR+)	26	2026/8	2
	NCT04465968	DEEP_OCEAN	(Durvalumab+RT+CT)+S+ (Durvalumab/RT+CT)	3yr-OS	Ⅲ	84	2030/8	3
	NCT04326153		(Sintilimab+CT)+S+(Sintilimab*8+CT*2)	2yr-DFS	Ⅲa	40	2022/12	2
	NCT03838159	NADIMII	(Nivolumab +CT)*3+S+(Nivolumab*1 y)	pCR	Ⅲ	90	2027/9	2
RCT	NCT02998528	CheckMate816	(Nivolumab+CT)+S	EFS, pCR	Ib-Ⅲa	350	2028/11	3
			S+CT
			(Nivolumab+Ipilimumab)+S
	NCT03425643	KEYNOTE-671	(Pembrolizumab+CT)*4+S+(Pembrolizumab*1 y)	EFS, OS	Ⅱ-Ⅲb (T3-4N2)	786	2026/6	3
			NAC+S
	NCT03456063	IMpower030	(Atezolizumab+CT)+S+(Atezolizumab*16)	MPR, EFS	Ⅱ-Ⅲb	450	2024/11	3
			NAC+S
	NCT03800134	AEGEAN	(Durvalumab+CT)+S	MPR, EFS	Ⅱ-Ⅲ	800	2024/1	3
			NAC+S
	NCT04025879		(Nivolumab+CT)+S+(Nivolumab)	EFS	IIa (> 4 cm)-Ⅲb (T3N2)	452	2024/9	3
			NAC+S
	NCT04338620		(Camrelizumab+CT)+S	pCR	Ⅲ (N2)	94	2021/11	2
			NAC+S
	NCT04379635		(Tislelizumab+CT)+S+(Tislelizumab)	MPR, EFS	Ⅱ-Ⅲa	380	2025/11	3
			NAC+S
	NCT04422392		(ICI+CT)+S+(ICI+CT)	MPR	Ⅲa (N2)	90	2025/6	2
			NAC+S+CT
	NCT04061590		Pembrolizumab +S	TIL	Ⅰ-Ⅲa	84	2022/4	2
			(Pembrolizumab+CT)+S
	NCT04459611	neoSCORE	(Sintilimab+CT)*2+S+(CT*2+Sintilimab*1 y)	MPR	Ib-Ⅲa	60	2023/7	2
			(Sintilimab+CT)*3+S+(CT*1+Sintilimab*1 y)
	NCT03916627		Cemiplimab+S+(Cemiplimab+CT)	MPR	NSCLC	94	2027/8	2
			(Cemiplimab+CT)+S+(Cemiplimab+CT)
			NAC+S+(Cemiplimab+CT)
Neoadjuvant ICI+RT	NCT02904954		Durvalumab+S+Durvalumab*1 y	MPR	Ib-Ⅲa	60	2022/4	2
			(Durvalumab*3+RT)+S+(Durvalumab*1 y)
	NCT03217071	PembroX	Pembrolizumab+S	TIL	Ⅰ-Ⅲa	40	2021/12	2
			(Pembrolizumab+RT)+S
	NCT03237377		(Durvalumab+RT)+S	Feasibility and saftey	Ⅲa	32	2021/9	2
			(Durvalumab+Tremelimumab+RT)+S
	NCT04245514	SAKK 16/18	(Durvalumab*1+CT*3+RT)+S+ (Durvalumab*13 q4w)	EFS	T1-4 (> 7 cm) N2	90	2025/3	2