Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors. (ATLANT)

Ipsen

Status and phase: Completed; Phase 2

Conditions: Neuroendocrine Tumours

Treatments: Drug: Lanreotide (Autogel formulation) and Temozolomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02698410

2014-005579-10 (EudraCT Number)

A-93-52030-325

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Lanreotide (Autogel formulation) and Temozolomide

Experimental group

Description:

Lanreotide ATG 120 mg every 28 days, deep subcutaneous injection for a maximum of 48 weeks, for a total number of 12 injections. Temozolomide 250 mg hard capsules, for 5 consecutive days every 28 days, oral route, for a maximum of 48 weeks.

Treatment:

Drug: Lanreotide (Autogel formulation) and Temozolomide