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

Status: administratively complete

This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary NETs. This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Phase will consist of two periods: Treatment Period and Follow-Up Period. The primary objective will be to describe the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects randomized to LAN with unresectable and/or metastatic well differentiated, typical or atypical bronchopulmonary neuroendocrine tumours. Recent updates of National Cancer Institute Cancer Network (NCCN) & European Neuroendocrine Tumor Society (ENETS) guidelines recommend SSA in first line for the treatment of locoregional unresectable or metastatic bronchopulmonary NETs as an option beyond 'observation' leading to slow and difficult recruitment in SPINET study. Consequently, it was decided to prematurely stop the recruitment in the SPINET study and to transition all subjects still treated in the double-blind phase to the open label (OL) treatment and follow-up phases following respective country approvals of Amendment #5. The new aim of this Phase 3, multicenter, prospective, randomized placebo-controlled clinical study is to describe the antitumor efficacy and safety of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) in subjects with well-differentiated, metastatic and/or unresectable, typical or atypical, bronchopulmonary NETs.

Inclusion Criteria

Have metastatic and/or unresectable pathologically confirmed well-differentiated, typical or atypical neuroendocrine tumor of the bronchopulmonary
Histologic evidence of Well differentiated Neuroendocrine tumors (NETs) of the bronchopulmonary (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 bronchopulmonary origin
Has been treated with a Somatostatin analog (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 bronchopulmonary NET

As planned initially, a total of 216 eligible patients with well-differentiated typical

or atypical, metastatic and/or unresectable bronchopulmonary NETs, and a positive

somatostatin receptor imaging (SRI) (Octreoscan® ≥ grade 2 Krenning scale; Ga-PET scan:

uptake greater than liver background), were to be randomized 2:1 to either LAN plus BSC

(120mg/28 days) or placebo plus BSC following the stratification of 1) typical versus

atypical and 2) prior chemotherapy versus no prior chemotherapy*.

* cytotoxic chemotherapy or molecular targeted therapy or interferon.

At the time of the premature stop of the recruitment (as per Protocol Amendment #5), 77

patients were enrolled. All patients still treated in the DB Phase were entered into the

OL Phase (either for Follow up or for OL treatment periods). The transition to the OL

periods was done on a country-basis and per patient, at the following planned scheduled

visit (i.e. approximately 28 days from the last injection). Patients enrolled into the

study not progressing at the time of study stop, and who agree to stay on LAN therapy

(i.e. OL Treatment Period) receive the study active treatment until evidence of disease

progression (based on local radiological assessment then confirmed centrally),

development of unacceptable toxicity, or premature withdrawal for any reason or up a

maximum of 18 months after the last patient randomized. After disease progression

patients are followed for survival, QoL and all subsequent anticancer treatments in the

OL Follow-up period up to the end of the study (i.e up to 18 months after the last

patient randomized).

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

Inclusion Criteria

Exclusion Criteria

United States

New Mexico

Albuquerque

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

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