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单药免疫治疗临床研究

Clinical trials of ICI monotherapy

Study	Phase	Histology, PD-L1	Line	Study design	Key findings	HR (95%CI)
PD-L1: programmed cell death ligand 1; ICIs: immune checkpoint inhibitors; TPS: tumor proportion score; NSCLC: non-small cell lung cancer; mOS: median overall survival; mPFS: median progression-free survival; Chemo: chemotherapy.
KEYNOTE-024[18]	Ⅲ	NSCLC, PD-L1 TPS≥50%	First-line	Pembrolizumab vs platinum-based chemotherapy	mOS: 30.0 mon vs 14.2 mon	0.63 (0.47-0.86)
KEYNOTE-042[19]	Ⅲ	NSCLC, PD-L1 TPS≥1%	First-line	Pembrolizumab vs platinum-based chemotherapy	mOS: 16.7 mon vs 12.1 mon	0.85 (0.71-0.93)
KEYNOTE-010[20]	Ⅱ/Ⅲ	NSCLC, PD-L1 TPS≥1%	Second-line	Pembrolizumab 2 mg/kg or10 mg/kg vs docetaxel	mOS: 10.4 mon vs 8.5 mon (2 mg/kg); mOS: 12.7 mon vs 8.5 mon (10 mg/kg)	2 mg/kg: 0.7110 mg/kg: 0.61
CheckMate026[21]	Ⅲ	NSCLC, PD-L1 TPS≥1%	First-line	Nivolumab vs platinum-based chemotherapy	mOS: 14.4 mon vs 13.2 mon	1.02 (0.80-1.30)
MYSTIC[22]	Ⅲ	NSCLC	First-line	Durvalumab vs valumab+Tremelimumab vs platinum-based chemotherapy	mOS: 16.3 mon vs 12.9 mon（D vs Chemo）mOS: 11.9 mon vs 12.9 mon（D+T vs Chemo）	D vs Chemo 0.76 (0.56-1.02)D+T vs Chemo 0.85 (0.61-1.17)
CheckMate017[23]	Ⅲ	Squamous	Second-line	Nivolumab vs docetaxel	mOS: 9.2 mon vs 6.0 mon	0.62 (0.47-0.80)
CheckMate057[24]	Ⅲ	Nonsquamous	Second-line	Nivolumab vs docetaxel	mOS: 12.2 mon vs 9.4 mon	0.75 (0.63-0.91)
OAK[25]	Ⅲ	NSCLC	Second-line	Atezolizumab vs docetaxel	mOS: 13.8 mon vs 9.6 mon	0.73 (0.62-0.87)