Table 2.

Key trials of immune checkpoint inhibitor (ICIs) targeting the programmed cell death‐1 (PD‐1) pathway in patients with non‐small‐cell lung cancer (NSCLC)

Trial name, Phase [Ref]	Disease	Trial drugs (dose)	Patient no.	1‐year OS rate (%)	Median OS (months)	Objective responses rate (%)	Median PFS (months)	Correlation between tumour PD‐L1 expression and response?	Treatment‐related adverse events (grade ≥ 3) (%)
CheckMate‐063 Phase III 101	Sq NSCLC	Niv (3 mg/kg)	117	40·8	8·2	14·5	1·9	Yes	17
CheckMate‐017 Phase III 99	Sq NSCLC	Niv (3 mg/kg) versus docetaxel	272	42 versus 24	9·2 versus 6·0	20 versus 9	3·5 versus 2·8	n.r.	7 versus 55
CheckMate‐057 Phase III 100	Non‐Sq NSCLC	Niv (3 mg/kg) versus docetaxel	582	51 versus 39	12·2 versus 9·4	19 versus 12	2·3 versus 4·2	Yes	10 versus 54
KEYNOTE‐001 Phase I 104	NSCLC	Pembro (2–10 mg/kg)	495	n.r.	12·0	19·4	3·7	Yes	9·5
KEYNOTE‐010 Phase II/III 102, 103	>1% PD‐L1 + NSCLC	Pembro (2 mg/kg) versus Pembro (10 mg/kg) versus Docetaxel	1034	43·2 versus 52·3 versus 34·6	10·4 versus 12·7 versus 8·5	n.r.	3·9 versus 4·0 versus 4·9	Yes	13 versus 16 versus 35
KEYNOTE‐024 Phase II 105	>50% PD‐L1 + NSCLC	Pembro (200 mg) versus docetaxel	305	n.r.	n.r.	44·8 versus 27·8	10·3 versus 6·0	High PD‐L1 a prerequisite for inclusion in trial	26·6 versus 53·3
POPLAR Phase II 106	NSCLC	Atezo (1200 mg) versus docetaxel	277	47·9 versus 37·8	12·6 versus 9·7	15 versus 15	2·7 versus 3·0	Yes	40 versus 53
OAK Phase III 107, 108	NSCLC	Atezo versus docetaxel	1225	55 versus 41	13·8 versus 9·6	14 versus 13	2·8 versus 4·0	Yes	37 versus 54
Phase 1b 109	NSCLC	Durvalumab + tremelimumab	102	n.r.	n.r.	0–23	n.r.	n.r.	36
CheckMate‐012 Phase 1 110	NSCLC	Niv (3 mg/kg) + Ipi versus Niv (3 mg/kg) + Ipi	77	Not calculated versus 69	n.r.	47 versus 38	8·1 versus 3·9	Yes	37 versus 33

Sq =  squamous; non‐sq = non‐squamous; niv = nivolumab; pembro = pembrolizumab; atezo = atezolizumab; ipi = ipilumumab; OS = overall survival; PFS = progression‐free survival; n.r. = not reported.