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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 : August 24, 2018
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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 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 : August 2019
Estimated Study Completion Date : August 2019


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



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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


  Show 57 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Medical Director Ipsen

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: August 24, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
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