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.
18 years and older patients.
Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient's awareness and willingness to comply with the study requirements.
Documented histological or cytological diagnosis of well differentiated Lung and GEP-NENs (NET G1, NET G2, NET G3 in WHO 2017 classification) progressing after a first line of therapy with SSAs, sunitinib, everolimus, chemotherapy and/or PRRT or documented histological or cytological diagnosis of Large cells neuroendocrine carcinoma patients with Ki67< 55% progressed after platinum-based first line chemotherapy.
Subjects must have evidence of progressed disease, radiologically documented in the 12 months previous study entry.
Receipt of any type of anticancer therapy within 4 weeks before study entry.
Previous treatment with Temozolomide or cabozantinib
Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before recruitment.
Previous PRRT treatment: Systemic treatment with radionuclides within 6 months before study entry.