At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Histologically or cytologically confirmed well-differentiated lung or GEP neuroendocrine tumors (NET G1, G2, G3 per WHO 2017) or large cell neuroendocrine carcinoma with Ki67<55%
- ✓Progressive disease after first-line therapy with SSAs, sunitinib, everolimus, chemotherapy, and/or PRRT
- ✓Radiologically documented disease progression within 12 months prior to study entry
- ✕Any anticancer therapy within 4 weeks before study entry
- ✕Prior treatment with temozolomide or cabozantinib
- ✕Radiation therapy for bone metastasis within 2 weeks, other external radiation within 4 weeks
- ✕PRRT treatment within 6 months before study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04893785Phase 2RecruitingUpdate OverdueUpdated 24mo ago · Completion was 17mo agoA Phase II Single Arm Interventional Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)
In Brief
A Phase 2 clinical trial evaluating Cabozantinib and Temozolomide for Lung Neuroendocrine Neoplasm and GEP Neuroendocrine Tumor. Currently recruiting, targeting 35 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first. Patients will be required to attend clinic on Day 1, Day 8, Day 14 and Day 22 of every 4 week cycle. Patients will return to clinic at 30 days (+/- 5 days) of their last dose of cabozantinib or temozolomide (whichever is discontinued last), for an end of treatment visit. Following their end of treatment visit patients will be followed-up 3-monthly during routine clinic appointments to collect data on further anti-cancer treatment and survival. Follow-up will continue until 6 months after the last patient stops study treatment or up to 18 months after the last patient is randomised, whichever is sooner.