Table 4.

Select ongoing first line trials for patients with metastatic NSCLC and PD-L1 ≥50% on tumor cells.

Regimen	Study design	NCT number	Primary outcome	Estimated completion date
Pembrolizumab + Decitabine + Tetrahydrouridine	Single arm phase I/II	NCT03233724	MTD and ORR	December 31, 2020
Pembrolizumab + Itacitinib	Single arm phase II	NCT03425006	ORR at 12 weeks and toxicity	June 2021
Pembrolizumab + AGEN1884	Single arm phase II	NCT03411473	DLT incidence	May 2021
Pembrolizumab + GRN1201/sargramostim	Single arm phase II	NCT03417882	ORR	March 2021
Pembrolizumab + AM0010 vs. Pembrolizumab (Cypress 1)	Randomized phase II	NCT03382899	ORR	December 2021
Pembrolizumab + Ipilimumab vs. Pembrolizumab + Placebo (KEYNOTE-598)	Randomized phase III	NCT03302234	PFS and OS	February 22, 2024
Pembrolizumab + IO102 vs. Pembrolizumab and Pembrolizumab + Carboplatin + Pemetrexed + IO102 vs. Pembrolizumab + Carboplatin + Pemetrexed	Randomized phase I/II	NCT03562871	DLT incidence, ORR	February 2022
Pembrolizumab + Carboplatin + Pemetrexed + NEO-PV-01/Adjuvant	Phase I	NCT03380871	DLT incidence	February 2021
Pembrolizumab + Platinum + Pemetrexed + Canakinumab vs. Pembrolizumab + Platinum + Pemetrexed (CANOPY-1)	Phase III	NCT03631199	DLT incidence, PFS, and OS	October 21, 2022

Decitabine is a histone deacetylase inhibitor. Tetrahydrouridine is a cytidine deaminase inhibitor. Itacitinib is a JAK1 inhibitor. AGEN1884 is a CTLA4 inhibitor. GRN1201/sargramostim is a cancer peptide vaccine. AM0010 is a recombinant interleukin 10. Ipilimumab is a CTLA4 inhibitor. IO102 is an IDO inhibitor. NEO-PV-01/Adjuvant is a personalized cancer vaccine and poly-ICLC, a dsRNA. Canakinumab is a monoclonal antibody that neutralizes IL-1β. Platinum includes either carboplatin or cisplatin. PD-L1, programmed death ligand 1; NCT, national clinical trials; ORR, objective response rate; PFS, progression free survival; OS, overall survival; DLT, dose limiting toxicity; MTD, maximum tolerated dose.