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.
Single group
Cabozantinib and Temozolomide
DrugPatients 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.
To assess the efficacy of the combination of cabozantinib and one-week-on/one-week-off temozolomide, based on overall response rate (ORR).
Overall Response Rate (ORR) (as assessed by RECIST v1.1) defined by complete response (CR) or partial response (PR).
To assess the activity of the combination of cabozantinib and one-week-on one-week-off temozolomide according to Progression Free Survival (PFS)
PFS (as assessed by RECIST v1.1) defined as time from study entry to first evidence of disease progression or death due to any cause.
To assess the activity of the combination of cabozantinib and one-week-on one-week-off temozolomide according to Clinical Benefit Rate (CBR)
CBR (as assessed by RECIST v1.1) defined by complete response (CR) or partial response (PR) or stable disease (SD).
To assess the activity of the combination of cabozantinib and one-week-on one-week-off temozolomide according to Overall Survival (OS)
OS defined as time from study entry to death due to any cause or to study termination
To assess the activity of the combination of cabozantinib and one-week-on one-week-off temozolomide according to duration of response (DOR)
DOR defined as time from study entry to change in response from CR or PR to Stable Disease (SD) or Progressive Disease (SD) (as assessed by RECIST v1.1).
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