Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumors

The DB Phase will include a Screening Visit to establish protocol eligibility and disease
characteristics. The Baseline Visit will confirm eligibility prior to randomization and
treatment. The DB Phase of the study will end on the date of data cut-off for the primary
analysis of PFS, which will occur when the target number of events (175 disease Progression
as centrally assessed or deaths reached) between the two treatment groups has been observed.

All subjects who are still on study treatment at that time will enter the OL Extension Phase
(either the Treatment Period or Follow-Up Period). In the OL Extension Treatment Period, the
subjects will be allowed to receive active treatment if they were randomized in the placebo
arm. During the OL Follow-up Period, all subjects will continue to be followed for QoL
survival and all subsequent anticancer treatments received will be recorded.

Both OL Extension Treatment Period and Follow-up Phases will end 6 months after the date of
data cut-off (175 events - progression as assessed centrally or death - are reached).

Inclusion Criteria:

- Have metastatic and/or unresectable pathologically confirmed well-differentiated,
typical or atypical neuroendocrine tumor of the lung

- Histologic evidence of Well differentiated Neuroendocrine tumors (NETs) of the lung
(typical and atypical according to the World Health Organisation (WHO criteria),
evaluated locally)

- Has a mitotic index <2 mitoses/2 mm2 for typical carcinoid (TC) and <10 mitoses/2 mm2
and/or foci of necrosis for atypical carcinoid (AC)

- At least one measurable lesion of the disease on imaging (CT or MRI; RECIST 1.1)

- Positive Somatostatin receptors (SSTR) imaging

Exclusion Criteria:

- Poorly differentiated or high grade carcinoma, or patients with neuroendocrine tumors
not of lung origin are excluded

- Has been treated with an Somatostatin analogs (SSA) at any time prior to
randomization, except if that treatment was for less than 15 days (e.g.
peri-operatively) of short acting SSA or one dose of long acting SSA and the treatment
was received more than 6 weeks prior to randomization

- Has been treated with Peptide receptor radionuclide therapy (PRRT) at any time prior
to randomization

- Has been treated with more than two lines of cytotoxic chemotherapy or molecular
targeted therapy or interferon for Lung NET