Study of Everolimus as Maintenance Therapy for Metastatic NEC With Pulmonary or Gastroenteropancreatic Origin

Inclusion Criteria:

* Histological / cytological diagnosis of GEP Neuroendocrine Carcinoma (NEC) with Ki67\< 55% (WHO 2010)
* Histological/cytological diagnosis of large-cells neuroendocrine carcinoma of the lung with Ki67 \<55%;
* Stable disease, partial response or complete response (Recist 1.1) after 6 cycles of first line chemotherapy with Cisplatin plus Etoposide or alternative first line chemotherapy according with local practice
* non functional NEC
* locally advanced inoperable or metastatic disease
* measurable or evaluable disease according to RECIST criteria (version 1.1)
* Age\> 18;
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
* Adequate bone marrow function (Hb\> 9.0 g / dL, absolute neutrophil count\> 1.5 x 109 / L, platelets\> 100 x 109 / L), renal function (serum creatinine \<2 mg / dL x upper limit of normal (ULN) or creatinine clearance, Cockroft formula, ≥ 30 ml / min), hepatic function (serum bilirubin \<1.5 x ULN, serum transaminases \<2.5 x ULN in the absence of liver metastases or \<5x ULN in the presence of liver metastases);
* Negative pregnancy test or breastfeeding women during childbearing age;
* Written informed consent;
* Approval of the Ethics Committee that will be required.

Exclusion Criteria:

* clinically significant cardiovascular disorders in the 6 months prior to randomization (congestive heart failure, myocardial infarction, unstable angina, severe uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular accidents, pulmonary thromboembolism);
* Functional Neuroendocrine Carcinoma NEC
* Neuroendocrine carcinoma with ki 67 \> 55%
* ongoing uncontrolled infection;
* Concomitant intake of:

  * Drugs incompatible with concomitant everolimus;
  * Any other drug in clinical trials;
* History of other malignancy except carcinoma in situ of the cervix or basal / squamous cell carcinoma of the skin adequately treated;
* Presence of brain metastases;
* Any other serious or uncontrolled concurrent disease conditions that the safe administration of medications