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

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ClinicalTrials.gov Identifier: NCT02683941
Recruitment Status : Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:

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 lung NETs This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Extension Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Extension Phase will consist of two periods: Treatment Period and Follow-Up Period.

The primary objective will be to compare the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days versus placebo plus BSC, 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 with unresectable and/or metastatic well differentiated, typical or atypical lung neuroendocrine tumours


Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Lanreotide (Autogel formulation) Drug: Placebo Phase 3

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Prospective, Randomized, Double-blind, Multi-center Study of the Efficacy and Safety of Lanreotide Autogel/Depot 120 mg Plus BSC vs. Placebo Plus BSC for Tumor Control in Subjects With Well Differentiated, Metastatic and/or Unresectable, Typical or Atypical, Lung Neuroendocrine Tumors
Actual Study Start Date : February 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020


Arm Intervention/treatment
Experimental: Lanreotide (Autogel formulation)
120mg every 28 days until disease progression
Drug: Lanreotide (Autogel formulation)
120mg every 28 days until disease progression
Other Names:
  • Lanreotide Depot
  • Somatuline

Placebo Comparator: Placebo
120mg every 28 days until disease progression, then patient may enter open-label treatment with Lanreotide
Drug: Placebo
Saline solution 0.9% administered via deep subcutaneous injection every 28 days until disease progression.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS), assessed by central review using RECIST v1.1 criteria [ Time Frame: From randomisation up to 18 months (approximately) after the last patient is randomised (175 progression/death events)] ]
    PFS measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, defined as the time from randomization to disease progression or death from any causes


Secondary Outcome Measures :
  1. Objective Response Rate (ORR): best overall response of complete response (CR) or partial response (PR) measured by RECIST v1.1 criteria [ Time Frame: Baseline, week 12, 24, 36, 48, 60, 72, early withdrawal visit (may occur at any time post treatment up to 72 weeks) ]
  2. Overall Survival, defined as the time from randomization to death from any causes [ Time Frame: From randomisation up to 18 months (approximately) after the last patient is randomised ]
    The analysis will occur when the target number of events (175 progression/death events) among the two treatment groups has been observed.

  3. Time to treatment failure, defined as the time from randomization to disease progression, withdrawal for any reason, or death using RECIST v1.1. assessment [ Time Frame: From randomisation up to 18 months (approximately) after the last patient is randomised (175 progression/death events)] ]
    The analysis will occur when the target number of events (175 progression/death events) among the two treatment groups has been observed.

  4. Mean changes from Baseline in the biomarker chromogranin A (CgA) [ Time Frame: Baseline, week 8, 12, 24, 36,48, 60, 72, early withdrawal visit (may occur at any time post treatment up to 72 weeks) and then every 12 weeks up to 18 months (approximately) after the last patient is randomised (175 progression/death events)] ]
  5. Proportion of subjects with a decrease of CgA ≥30% at week 8 in the population of subjects with an elevated CgA (≥2 x ULN) at Baseline [ Time Frame: Baseline, week 8 ]
  6. Change in Quality of Life (QoL), as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 [ Time Frame: Baseline, week 12, 24, 36, 48, 60, 72, early withdrawal visit (may occur at any time post treatment up to 72 weeks) and then every 12 weeks up to 18 months (approximately) after the last patient is randomised (175 progression/death events)] ]
  7. Time to QoL deterioration, defined by a decrease from baseline in EORTC Quality of Life Questionnaire C30 (QLQ-C30) score of at least 10 points [ Time Frame: Baseline, week 12, 24, 36, 48, 60, 72, early withdrawal visit (may occur at any time post treatment up to 72 weeks) and then every 12 weeks up to 18 months (approximately) after the last patient is randomised (175 progression/death events)] ]
  8. Mean changes from Baseline in urinary 5-HIAA levels in subjects with elevated urinary 5-hydroxyindoleacetic acid (5-HIAA) (≥2 x Upper limit of normal range) at Baseline [ Time Frame: Baseline, week 8, 12, 24, 36, 48, 60, 72 and early withdrawal visit (may occur at any time post treatment up to 72 weeks) and then every 12 weeks up to 18 months (approximately) after the last patient is randomised (175 progression/death events)] ]
  9. Plasma Concentration of lanreotide in serum [ Time Frame: Baseline, week 24, week 36, early withdrawal visit (may occur at any time post treatment up to 72 weeks) ]
    Pharmacokinetics (PK) of LAN



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683941


  Hide Study Locations
Locations
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United States, Arizona
Arizona Oncology Associates
Tucson, Arizona, United States, 85711
United States, California
VA Greater Los Angeles
Los Angeles, California, United States, 90073
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Dana-Farber Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Roswell Park Cancer Center
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45237
United States, Oregon
Oregon Health and Science Center
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Oncology
Dallas, Texas, United States, 75246
Texas Oncology-Forth Worth
Fort Worth, Texas, United States, 76104
Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
AKH und Med. University Vienna Allg Krankenhaus Wien
Wien, Austria, 1090
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, 2TN 4N2
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University Health Center
Montréal, Quebec, Canada, H4A 3J1
Canada
Saskatoon Cancer Centre
Saskatoon, Canada, S7N 4H4
Cancer Care of Manitoba
Winnipeg, Canada, R3E0V9
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
NET-Centre, Rigshospitalet
Copenhagen, Denmark, 2100
France
Centre Oscar Lambret
Lille, France, 59020
Hôpital Edouard Herriot
Lyon, France, 69437
CLLC, Institut Paoli Calmettes
Marseille, France, 13273
Institut du Cancer de Montpellier (ICM) Val d'Aurelle
Montpellier, France, 34000
CHU de Rennes - Hôpital Pontchaillou
Rennes, France, 35033
Centre René Gauducheau ICO institut de Cancerologie de l'Ouest
Saint-Herblain, France, 44805
Institut Gustave Roussy
Villejuif, France, 94800
Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
Evangelische Lungenklinik Berlin
Berlin, Germany, 13125
Universitätsklinikum Essen (AöR)
Essen, Germany, 45145
Johann Wolfgang Goethe-Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Italy
Universita di Genova
Genova, Italy, 16132
Insituti Scientifico Romagnolo per lo Studio e la cura dei Tumori (IRST)
Meldola, Italy, 47014
Azienda Ospedaliera Antonio Cardarelli
Napoli, Italy, 80131
Azienda Ospedaliera Universitaria di Perugia Santa Maria della Misericordia
Perugia, Italy, 06123
Insittuto Clinico Humanitas
Rozzano, Italy, 20089
Netherlands
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Poland
Zakladu Medycyny Nuklearne i Endokrynologii Onkologicznej
Gliwice, Poland, 44-101
University Center of Ophtalmology & Oncology
Katowice, Poland, 40-514
Szpital Uniwersytecki W
Krakow, Poland, 31-501
Szpital Kliniczny im. H. Święcickiego U.M.
Poznan, Poland, 60-355
GAMMED
Warszawa, Poland, 02-348
Spain
Hospital Universitari, Vall d'Hebron
Barcelona, Spain, 8035
University Hospital Ramón y Cajal
Madrid, Spain, 28412
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
United Kingdom
Cancer Center, Beatson Oncology
Glasgow, United Kingdom, G12 0YN
Royal Surrey County Hospital
Guildford, United Kingdom, GU2 7XX
Royal Free Hospital
London, United Kingdom, NW3 2QC
King's College Hospital
London, United Kingdom, SE5 9RS
Christie Hospital
Manchester, United Kingdom, M20 4BX
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02683941     History of Changes
Other Study ID Numbers: A-US-52030-328
2015-004992-62 ( EudraCT Number )
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs