Study design and patients
lung primary carcinomas, NET, NENs, tumour, advanced/metastatic NEN
CARCINOIDS, DISEASE, TUMOUR, -20, ONCOLOGY
This study was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation Guidelines for Good Clinical Practice. The study protocol (see Supplementary Note in the DUNE (EudraCT: 2016-002858-20; NCT03095274) is a prospective, single-arm, open-label, multicohort, multicentre, phase II trial involving 20 institutions in Spain. Eligible patients presented with a histologically confirmed diagnosis of advanced/metastatic NEN and had progressed to standard anticancer therapies according to tumour type. Patients were enrolled in four cohorts according to the type of NET: well-moderately differentiated NETs of the lung, also known as typical and atypical lung carcinoids, that have progressed to prior somatostatin analogues therapy, one prior targeted therapy or chemotherapy (Cohort 1); well-moderately differentiated, World Health Organisation (WHO) grade 1 and 2, gastrointestinal NETs after progression to somatostatin analogues and one targeted therapy, interferon or radionuclides (Cohort 2); well-moderately differentiated, WHO grade 1 and 2 NET, from pancreatic origin after progression to at least two and a maximum of four standard therapies, including chemotherapy, somatostatin analogues and target therapy (Cohort 3); WHO grade 3 NENs, of gastroenteropancreatic or unknown primary origin, excluding lung primary carcinomas, after progression to first-line chemotherapy with a platinum-based regimen (Cohort 4). The trial used the WHO 2010 classification for NETs. General inclusion criteria also included patients >18 years; Eastern Cooperative Oncology Group performance status (ECOG PS) 0–1; life expectancy >12 weeks; adequate haematologic, hepatic, and renal function; measurable disease according to Response Criteria in Solid Tumours (RECIST) version 1.1Accrual started on and finished on April 12th, 2017 and finished on November 30th, 2019. Accrual was competitive and sequential. The trial was registered on 