Table 3.

Selected ongoing pembrolizumab trials

Trial name/NCT reference	Phase	Setting	Therapy	Histology	End points (secondary)
KEYNOTE-011/NCT01840579	I	Advanced, treatment-naive NSCLC	PEMBRO±PT-DC	All	PFS (ORR, OS, DOR, safety)
KEYNOTE-021/NCT02039674	I/II	Advanced, treatment-naive NSCLC	PEMBRO+PT-DC	All	PFS (ORR, OS, DOR, safety)
KEYNOTE-025/NCT02007070	Ib	Advanced, treatment-naive NSCLC	PEMBRO 10Q3W	All	ORR (safety, PFS, DOR, OS)
KEYNOTE-028/NCT02054806	Ib	Advanced SCLC	PEMBRO Q2W	SCLC	ORR (PFS, OS, DOR)
KEYNOTE-042/NCT02220894	III	Advanced, treatment-naive NSCLC	PEMBRO vs PT-DC	PD-L1+	OS (PFS)
KEYNOTE-091/NCT02504372	Ib/II	Adjuvant NSCLC	PEMBRO vs placebo	All	DFS (OS, DFS)
KEYNOTE-189/NCT02578680	III	Advanced, treatment-naive NSCLC	PT-DC alone vs PT-DC+PEMBRO	All	PFS (ORR, OS, DOR, safety)
KEYNOTE-407/NCT02775435	III	Advanced, treatment-naive NSCLC	PT-DC±PEMBRO	SQ	PFS (ORR, OS, DOR, safety)
HCRN LUN 14-179/NCT02343952	II	Stage IIIB, treatment-naive NSCLC	PEMBRO+CHEMORT	All	PFS (ORR, OS, DOR, safety)
BATTLE-2/NCT01248247	II	Advanced, treatment-naive NSCLC	PEMBRO+erlotinib/AZD6244/SOR	All	DCR
ENCORE 601/NCT02437136	I/II	Advanced, pretreated NSCLC	Entinostat+PEMBRO	All	ORR (PFS, OS, DOR)
NCT02364609	I	Advanced, pretreated EGFR+NSCLC	PEMBRO+afatinib	All	MTD, dose (ORR, PFS)
NCT02451930	I	Advanced, pretreated NSCLC	PEMBRO+necitumumab	All	DLTs (ORR, PFS, DOR, OS)
NCT02637531	I/Ib	Advanced, pretreated NSCLC	IPI-549±PEMBRO	All	Safety (ORR, PFS, OS)

Abbreviations: NSCLC, non-small-cell lung cancer; OS, overall survival; PEMBRO, pembrolizumab; PT-DC, platinum-doublet chemotherapy; PFS, progression-free survival; SCLC, small-cell lung cancer; SOR, sorafenib; ORR, overall response rate; DOR, duration of response; DCR, disease control rate; MTD, maximum tolerated dose; DLTs, dose-limiting toxicities; CHEMORT, chemoradiotherapy.