Table 1.

Clinical trials of neoadjuvant immune monotherapy for resectable NSCLC and corresponding posted results

Identifier	Trials	Phase	Population	EGFR (sensitive)/ALK alternation exclusiveness	Sample size (N)	Intervention	Primary endpoints	Study group outcomes	Control group outcomes	≥grade 3 irAE	Resection rate	Surgical delay rate
NCT02938620 28	MK3475‐223	1	I‐II	No	28	pembrolizumab 200 mg × 1/q3w × 2—surgery	Toxicity, MPR	66.6% near pCR	‐	NA	NA	NA
ChiCTR‐OIC‐17013726 29	/	1b	IA‐IIIB	Yes	40	Sintilimab 200 mg q3w × 2—surgery	Safety	MPR 40.5%pCR 16.2%	Single arm	10%	92.5%	5%
NCT02259621 21	CheckMate159	2	I‐IIIA	No	21	nivolumab 3 mg/kg q2w × 2—surgery	Safety and feasibility	MPR 45%, pCR 10%	Single arm	4.5%	95%	0
NCT02927301 30	LCMC3	2	IB‐IIIB	No	181	Atezolizumab 1200 mg, q21d × 2—surgery—optional atezolizumab × 1 year	MPR	MPR 21%, pCR 7%	Single arm	29.6%	92.6%	1.9%
NCT03158129 33	NEOSTAR	2	I‐IIIA	No	44	Nivolumab 3 mg/kg q2w × 3 ± ipilimumab 1 mg/kg × 1—surgery—SOC adjuvant therapy	MPR	MPR 22%, pCR 9%	MPR 38%, pCR 29%	13%	89%	22%
NCT02994576 34	PRINCEPS	2	I( ≥ 2 cm)‐IIIA（non N2）	No	30	Atezolizumab 1200 mg, q21d × 1—surgery	Tolerance	MPR 14%pCR 16.2%	Single arm	3.3%	100%	0
NCT03030131 35	IFCT‐1601 IONESCO	2	IB( > 4 cm)‐IIIA (non N2)	No	46	Durvalumab 750 mg q2w × 3—surgery	% Of R0 resection	89.1% R0 resectionMPR 18.6%pCR 7%	Single arm	0	100%	NA
NCT02818920 36	TOP1501	2	IB‐IIIA	No	30	pembrolizumab 200 mg q3w × 2—surgery—SOC adjuvant therapy ± radiation +  pembrolizumab 200 mg q3w × 4	Safety and efficacy	88% R0 resectionMPR 28%pCR 12%	Single arm	3.3%	83.3%	3.3%

Abbreviations: MPR, major pathological response; NA, data are not available; pCR, pathological complete response; SOC, standard of care.