Table 2.

NEPA study designs.

Study	Study design	Patient population/chemotherapy	Treatment groups	Single versus multiple cycle	Study objective
Study 1  [Hesketh et al.]  [33]	Double-blind, randomized, dose-ranging, parallel group Phase 2 (N = 694)	Chemotherapy-naïve Cisplatin-based chemotherapy (HEC)	NEPA100 + DEX NEPA200 + DEX NEPA300 + DEX Oral PALO + DEX APR + IV OND + DEX (included as exploratory)	Single cycle	Identify best dose of NETU + PALO; demonstrate superiority of NEPA over oral PALO
Study 2  [Aapro et al.]   [34]	Double-blind, randomized, parallel group Phase 3 (N = 1455)	Chemotherapy-naïve Anthracycline-cyclophosphamide	NEPA + DEX Oral PALO + DEX	Multiple cycle	Demonstrate superiority of NEPA over oral PALO
Study 3  [Gralla et al.]   [35]	Double-blind, randomized 3 : 1, parallel group Phase 3 (N = 413)	Chemotherapy-naïve Any HEC or MEC (except AC)	NEPA + DEX APR + oral PALO + DEX (3 : 1 randomization)	Multiple cycle	Demonstrate multiple cycle safety and describe efficacy of NEPA

HEC: highly emetogenic chemotherapy; MEC: moderately emetogenic chemotherapy; AC: anthracycline cyclophosphamide; DEX: dexamethasone; PALO: palonosetron; NETU: netupitant; APR: aprepitant; OND: ondansetron; NEPA₁₀₀: NETU 100 mg + oral PALO 0.50 mg; NEPA₂₀₀: NETU 200 mg + oral PALO 0.50 mg; NEPA₃₀₀: NETU 300 mg + oral PALO 0.50 mg; IV: intravenous.