Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors.
Condition: Neuroendocrine Tumours
MeSH terms: Neuroendocrine Tumors
Intervention: Lanreotide (Autogel formulation) and Temozolomide
Intervention MeSH terms: Temozolomide; Lanreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the protocol is to evaluate the efficacy and safety of Lanreotide ATG 120 mg
      in combination with Temozolomide in subjects with unresectable advanced neuroendocrine
      tumours of the lung or thymus as Disease Control Rate at 9 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological documented unresectable advanced (locally or metastatic) well or
             moderately differentiated neuroendocrine tumors of the lung or thymus (typical and
             atypical carcinoids according to the World Health Organisation (WHO) 2004 criteria);

          -  Imaging documented progression within 12 months before screening visit (V1), according
             to RECIST criteria v 1.1;

          -  Measurable disease, as defined by RECIST criteria v 1.1, on a CT scan performed at
             screening visit (V1);

          -  Octreoscan or Ga68-DOTA-TATE/TOC/NOC-PET-TC within 12 months before screening visit
             (V1);

          -  Adequate liver, renal and bone marrow function.

        Exclusion Criteria:

          -  Poorly differentiated neuroendocrine carcinoma and mixed Neuroendocrine tumours (NET),
             according to WHO 2004 criteria

          -  Neuroendocrine tumours other than lung or thymus

          -  Non-neuroendocrine thymic neoplasm

          -  Received a prior therapy with Peptide Receptor Radionuclide Therapy (PRRT) within 6
             months prior to screening visit (V1)

          -  Treated with systemic therapies (chemotherapy, interferon-alpha, somatostatin
             analogues, molecular target therapies) within 1 month prior to screening visit (V1)

          -  Treated with a number of systemic therapy lines > 3 prior to screening visit (V1), and
             any of the following:

               1. for chemotherapy no more than 1 line prior to V1

               2. for somatostatin analogue no more than 1 line therapy, considered as treatment
                  lasting more than 6 months, prior to V1 no therapy with Temozolomide (TMZ) prior
                  to V1

               3. Received a prior therapy with Peptide Receptor Radionuclide Therapy (PRRT) within
                  6 months prior to screening visit (V1)

          -  Received external palliative radiotherapy within the last 28 days prior to screening
             visit (V1)

          -  Received locoregional therapies (Transarterial embolization, Transcatheter arterial
             chemoembolization, thermo-ablation with radio-frequency) and Selective internal
             radiotherapy within 3 months prior to screening visit (V1)

          -  Presence of symptomatic brain metastasis

          -  Subjects with symptomatic cholelithiasis at screening visit (V1)