Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg

Inclusion Criteria:

- Histopathologically confirmed, grade 1 or 2, metastatic or locally advanced,
unresectable pNET (pNET cohort) or midgut NET (midgut cohort) with or without hormone
related syndromes, with a proliferation index (Ki67) ≤20%.

- Positive somatostatin receptors type 2

- Progression as assessed by an independent central reviewer according to RECIST v1.0
while receiving first line treatment with lanreotide Autogel® at a standard dose of
120 mg every 28 days for at least 24 weeks

Exclusion Criteria:

- Grade 3 or rapidly progressive (within 12 weeks) NET

- Any NET other than pancreatic and midgut

- Previous treatment with any antitumour agent for NET other than lanreotide Autogel®
120 mg every 28 days

- Gallbladder lithiasis at Screening echography or history of cholelithiasis with no
cholecystectomy since then.