A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)

Phase 2 Recruiting 35 enrolled National Cancer Institute, Naples

NaSingle-groupOpen-labelTreatment

Summary

The aim of CABOTEM study is to demonstrate the safety and activity of the Cabozantinib and Temozolomide combination in Lung and GEP-NENs patients, progressing after a first line therapy, including target therapies (everolimus, sunitinib) and / or chemotherapy, in the approved setting.

Timeline

Start: 2021-06-15
Primary completion: 2025-01
Completion: 2026-12

Outcome

Missed primary endpoint

paper The ORR was 15% (95% CI, 5-31%) and did not meet the primary endpoint. PMID 41963331 ↗

Publications

Cives M, Della Vittoria Scarpati G, Clemente O, Lauricella E, Bracigliano A, Badalamenti G, Delrio P, Cannella L, Picone C, Ragno A, Chaoul N, Della Monica R, Di Mauro A, Pizzolorusso A, Sorino J, Buonaiuto M, Ingravallo G, Picozzi F, Pignataro P, Ferrara G, Porta C, Tafuto S. Cabozantinib and temozolomide in patients with advanced progressive neuroendocrine tumors: a phase 2 study. Nat Commun. 2026 Apr 10;17(1):5113. doi: 10.1038/s41467-026-71756-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cabozantinib	Small molecule	40 mg	Oral
Subject	Temozolomide	Small molecule	100 mg/m2	—