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

NCT02698410 | Completed Phase 2 Results

• 2 other identifiers: A-93-52030-3252014-005579-10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Neuroendocrine Tumours

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR) Assessed Locally at Month 9

  Responders were participants who showed disease control according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria v 1.1 assessed locally by the investigator. The DCR was defined as complete response (CR), partial response (PR) or stable disease (SD) according to RECIST criteria v1.1. A sensitivity analysis-1 of local DCR was performed excluding participants withdrawn before 9 months with reason other than progressive disease (PD) or missing assessment and considering participants with PD prior or at 9 months as failures. In addition, a sensitivity analysis-2 was performed in order to consider assessments done between 7.5 and 10.5 months as 9 months assessments when 9-month assessment was missing using same methodology, i.e. considering PD prior or at 9 months and participants withdrawn with other or missing reasons as failures.

  Up to Month 9; for sensitivity analysis-2, up to 10.5 months

Secondary Outcomes (15)

• DCR Assessed Centrally at Month 9

  Up to Month 9

• Median Progression Free Survival (PFS) Assessed Locally and Centrally

  From Day 1 up to end of study, 52 weeks

• Median Time to Response (TTR) Assessed Locally and Centrally

  From Day 1 up to end of study, 52 weeks

• Median Duration of Response (DOR) Assessed Locally and Centrally

  From Day 1 up to end of study, 52 weeks

• Median Time to Progression (TTP) Assessed Locally and Centrally

  From Day 1 up to end of study, 52 weeks

Study Arms (1)

Lanreotide (Autogel formulation) and Temozolomide

EXPERIMENTAL

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.

Drug: Lanreotide (Autogel formulation) and Temozolomide

Interventions

Lanreotide (Autogel formulation) and Temozolomide DRUG

Lanreotide (Autogel formulation) and Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• for chemotherapy no more than 1 line prior to V1
• 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
• 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)

Sponsors & Collaborators

• Ipsen: lead

Study Sites (10)

Oncologia Medica - Istituto Oncologico del Mediterraneo - IOM

Viagrande, Catania, 95029, Italy

Location

Unità Operativa di Oncologia Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l., IRCCS

Meldola, 47014, Italy

Location

Unità Oncologia Medica Gastrointestinale e Tumori Neuroendocrini Istituto Europeo di Oncologia, IEO

Milan, 20141, Italy

Location

Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica , Università degli Studi

Napoli, 80131, Italy

Location

Dipartimento di Oncologia Università di Torino Ospedale San Luigi Gonzaga

Orbassano, 10043, Italy

Location

S.C di Oncologia Medica, Azienda Ospedaliera Universitaria di Perugia

Perugia, 06123, Italy

Location

U.O. Oncologia - Azienda Ospedaliero-Universitaria Pisana Ospedale S. Chiara

Pisa, 56126, Italy

Location

Oncologia Medica - Istituto Tumori Regina Elena San Gallicano

Roma, 00144, Italy

Location

OUC di Oncologia- Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma

Verona, 37134, Italy

Location

Related Publications (1)

• Ferolla P, Berruti A, Spada F, Brizzi MP, Ibrahim T, Marconcini R, Giuffrida D, Amoroso V, La Salvia A, Vaccaro V, Faggiano A, Colao A, Volante M, Ghizzoni S, Mazzanti P, Houchard A, Fazio N. Efficacy and Safety of Lanreotide Autogel and Temozolomide Combination Therapy in Progressive Thoracic Neuroendocrine Tumors (Carcinoid): Results from the Phase 2 ATLANT Study. Neuroendocrinology. 2023;113(3):332-342. doi: 10.1159/000526811. Epub 2022 Aug 31.

  PMID: 36044870 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

lanreotide; Temozolomide

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ipsen Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 3, 2016
• Study Start: July 1, 2016
• Primary Completion: February 8, 2019
• Study Completion: June 18, 2019
• Last Updated: October 1, 2020
• Results First Posted: October 1, 2020

Record last verified: 2020-09

Locations

IT (10)