. Author manuscript; available in PMC: 2020 May 15.

Published in final edited form as: Expert Rev Gastroenterol Hepatol. 2019 Oct 30;13(11):1023–1031. doi: 10.1080/17474124.2019.1685381

Table 2.

Ongoing phase I and phase II studies of ¹⁷⁷Lu-DOTATATE.

Study	Phase	Treatment	Patient Population	Outcome(s)
NCT03206060	II	¹⁷⁷Lu-DOTATATE	Inoperable Paragangliomas and Pheochromocytomas	PFS (primary) and assess safety profile (secondary)
NCT03325816	I/II	¹⁷⁷Lu-DOTATATE plus nivolumab	Inoperable Lung NETs or Refractory Extensive-Stage Small Cell Lung Cancer	RP2D (primary in phase I) and PFS (primary in phase II). Secondary outcomes include assessing safety profile (both phases), OS (phase II), DCR (phase II) and ORR (phase II)
NCT03971461	II	¹⁷⁷Lu-DOTATATE	G1-G3 Progressive or High-Risk Meningioma	6-month PFS (primary). Secondary outcomes include ORR, 12-month OS, PFS and OS.
NCT01456078	II	¹⁷⁷Lu-DOTATATE	G1-G2 Progressive NETs	Objective tumor response after cumulative kidney BED of 27 ± 2 Gy. Secondary outcome, objective tumor response after receiving a cumulative BED to the kidneys of 40 ± 2 Gy per RECIST 1.1
NCT03454763	II	¹⁷⁷Lu-DOTATATE	NETs of Any Stage	PFS and treatment emergent AEs (primary); 5-year DCR and OS (secondary)
NCT04029428	II	¹⁷⁷Lu-DOTATATE ± ⁹⁰Y-DOTATATE	G1-G3 GEP-NETs, Lung NETs, Pheochromocytoma and Paraganglioma, NET-CUP – with overexpression of somatostatin receptors	PFS (primary) and OS, performance status, cancer related symptoms, Hormonal overproduction symptoms, ORR, safety assessments, vital signs, BMI, and ECG analysis (secondary)
NCT03590119	II	¹⁷⁷Lu-DOTATATE (intra-arterial)	G1/G2 NETs	Difference in post-treatment tumor to non-tumor concentration between intra-arterial and intravenous treated liver lobe at 24 hours (primary); difference in post-treatment tumor at 3 and 6 months, toxicity, uptake of 177Lu-DOTATATE in extrahepatic lesions at 24 hours (secondary)
NCT02230176	II	¹⁷⁷Lu-DOTATATE vs sunitinib	Well-differentiated PNETs	12-month PFS (primary) and OS, best responses per RECIST 1.1–48 months (secondary)

Abbreviations: NETS, neuroendocrine tumors; PNET, pancreatic neuroendocrine tumor; G, grade; NET-CUP, neuroendocrine tumor-carcinoma of unknown primary; PFS, progression-free survival, RP2D, recommended phase 2 dose; OS, overall survival; DCR, disease control rate; ORR, objective response rate; AEs, adverse events; BED, biologic effective dose; BMI, body mass index; vs, versus; ¹⁷⁷ Lu, lutetium-177; ⁹⁰Y, yttrium-90; Gy, gray