Progress in immunotherapy for neuroendocrine neoplasm of the digestive system

Table 2 Ongoing clinical trials related to immune checkpoint inhibitors in neuroendocrine neoplasms of the digestive system

Indentifier of Clinical Trails	Intervention	Study phase	Primary outcome measures	Estimated or actual enrollment	Trial status	Estimated study completion date	Condition related to NENs of the digestive system
NCT04079712	Nivolumab + Ipilimumab + Cabozantinib	II	overall response rate	30	Active, not recruiting	October 2023	NECs: Excluding SCLC and MCC
NCT03980925	Nivolumab + Platinum-doublet chemotherapy	II	OS at 12 mo	38	Active, not recruiting	December 2023	G3 NENs: GEP or unknown primary site
NCT04197310	Cabozantinib + Nivolumab	II	ORR	35	Active, not recruiting	December 2023	WD-NET: Non-pancreatic (i.e., carcinoid) origin
NCT03290079	Pembrolizumab + Lenvatinib	II	ORR	28	Active, not recruiting	January 2024	NETs: WD small bowel or colon origin, including unknown primary, excluding pNENs
NCT04400474	Cabozantinib + Atezolizumab	II	ORR	93	Active, not recruiting	March 2024	WD G1/2 NET: Digestive system; G3 NEN: Excluding SCLC
NCT04579757	Surufatinib + Tislelizumab	Ib/II	DLT, ORR	135	Active, not recruiting	June 2024	G1/2 NETs: Thoracic or GEP origins
NCT04525638	Nivolumab + 177Lu-DOTATATE	II	overall response rate	30	Recruiting	September 2024	G3 NET or NEC of GEP, lung, and unknown primary site
NCT05058651	Atezolizumab + Platinum drug (cisplatin or carboplatin) + Etoposide	II/III	OS	189	Recruiting	October 2024	NEC: Extrapulmonary
NCT05113355	Chidamide + Sintilimab	II	ORR	23	Recruiting	November 2024	High-grade NEN, advanced and metastatic
NCT04969887	Nivolumab + Ipilimumab	II	CBR, 6 mo PFS	240	Recruiting	December 2024	NECs and G3 NETs: Independent of primary site, excluding SCLC
NCT04701307	Dostarlimab + Niraparib	II	6 mo PFS, 3 mo ORR	48	Active, not recruiting	May 2025	NECs: Excluding prostate origin
NCT03475953	Avelumab + Regorafenib	I/II	Phase I: Recommended dose of regorafenib; Phase II (cohort G): CR or PR	747 (only cohort G consists of GEP-NETs)	Recruiting	December 2025	G2/3 GEP-NETs
NCT05746208	Lenvatinib + Pembrolizumab	II	ORR	29	Not yet recruiting	July 2027	WD G3 NET: GIsite and pancreas primary
NCT05289856	Avelumab + Cabozantinib	II	DCR, CR, PR, SD	30	Recruiting	December 2025	G3 NET: Excluding MCC and SCLC
NCT05627427	Surufatinib + Sintilimab	II	PFS	60	Recruiting	December 2024	G3 NET and NEC: Metastatic and advanced
NCT05262556	NP-101 (TQ Formula) + Nivolumab + Ipilimumab	I	CR, PR, SD	10	Recruiting	December 2024	GEP-NET, GEP-NEC: Poorly differentiated

CR: Complete response; CBR: Clinical benefit rate; DCR: Disease control rate; DLT: Dose-limiting toxicity; ORR: Objective response rate; OS: Overall survival; PFS: Progression-free survival; PR: Partial response; WD: Well differentiated; NET: Neuroendocrine tumor; NEN: Neuroendocrine neoplasm; NEC: Neuroendocrine carcinoma; GEP: Gastroenteropancreatic; SCLC: Small cell lung cancer; MCC: Merkel cell carcinoma; pNET: Pancreas NET; GI: gastrointestinal; G1, 2, 3: Grade 1, 2, 3.