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Study · Randomized controlled trial · n = 77 · 2024

8 results

Treatment of advanced BP-NETS with lanreotide autogel/depot vs placebo: the phase III SPINET study.

Baudin E, Capdevila J, Hörsch D, Singh S, Caplin ME, Wolin EM, Buikhuisen W, Raderer M, Dansin E, Grohe C, Ferone D, Houchard A, Truong-Thanh XM, Reidy-Lagunes D

Endocrine-related cancer22 Jul 2024Cited by 23 (Europe PMC)

PMID38913539 (opens in a new tab)PMCIDPMC11301421 (opens in a new tab)DOI10.1530/erc-23-0337 (opens in a new tab)PepBankPUB-38913539
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Summary

Prospective data are lacking on early somatostatin analog (SSA) therapy in bronchopulmonary neuroendocrine tumors (BP-NETs; typical carcinoids and atypical carcinoids (TCs and ACs)). SPINET (EudraCT: 2015-004992-62; NCT02683941) was a phase III, double-blind study of lanreotide autogel/depot (LAN; 120 mg every 28 days) plus best supportive care (BSC) vs placebo plus BSC, with an optional open-label treatment phase (LAN plus BSC). Patients had metastatic/unresectable, somatostatin receptor (SSTR)-positive TCs or ACs. Recruitment was stopped early owing to slow accrual; eligible patients from the double-blind phase transitioned to open-label LAN. The adapted primary endpoint was progression-free survival (PFS) during either phase for patients receiving LAN. Seventy-seven patients were randomized (LAN, n = 51 (TCs, n = 29; ACs, n = 22); placebo, n = 26 (TCs, n = 16; ACs, n = 10)). Median (95% CI) PFS during double-blind and open-label phases in patients receiving LAN was 16.6 (11.3; 21.9) months overall (primary endpoint), 21.9 (12.8, not calculable (NC)) months in TCs, and 13.8 (5.4; 16.6) months in ACs. During double-blind treatment, median (95% CI) PFS was 16.6 (11.3; 21.9) months for LAN vs 13.6 (8.3; NC) months for placebo (not significant); corresponding values were 21.9 (13.8; NC) and 13.9 (13.4; NC) months, respectively, in TCs and 13.8 (5.4; 16.6) and 11.0 (2.8; 16.9) months, respectively, in ACs. Patients' quality of life did not deteriorate and LAN was well tolerated. Although recruitment stopped early and the predefined sample size was not met, SPINET is the largest prospective study to date of SSA therapy in SSTR-positive TCs and ACs and suggests clinical benefit in TCs.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In advanced BP-NETs, double-blind median PFS was 16.6 months (95% CI 11.3; 21.9) with lanreotide versus 13.6 (8.3; NC) with placebo, without significance.

    In plain wordsIn advanced BP-NETs, median time without progression was 16.6 months with lanreotide versus 13.6 with placebo, without a significant difference.

    Peptide
    Lanreotide
    Outcome
    No significant changeDouble-blind progression-free survival
    Study

    n = 77

    Comparator
    placebo
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 28 daysAs given in this study (human).

    Measurements

    Median progression-free survival
    16.6 months
    double-blind, lanreotide
    Median PFS 95% CI
    11.3 to 21.9 months
    double-blind, lanreotide
    Median progression-free survival
    13.6 months
    double-blind, placebo
    Median PFS 95% CI lower bound
    8.3 months
    double-blind, placebo; upper bound not calculable (NC)

    Source sentences

    Summary
    During double-blind treatment, median (95% CI) PFS was 16.6 (11.3; 21.9) months for LAN vs 13.6 (8.3; NC) months for placebo (not significant);
    3 context sentences
    Summary · context
    SPINET (EudraCT: 2015-004992-62; NCT02683941) was a phase III, double-blind study of lanreotide autogel/depot (LAN; 120 mg every 28 days) plus best supportive care (BSC) vs placebo plus BSC, with an optional open-label treatment phase (LAN plus BSC).
    Summary · context
    Patients had metastatic/unresectable, somatostatin receptor (SSTR)-positive TCs or ACs.
    Summary · context
    Seventy-seven patients were randomized (LAN, n = 51 (TCs, n = 29; ACs, n = 22); placebo, n = 26 (TCs, n = 16; ACs, n = 10)).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In atypical carcinoids, median double-blind PFS was 13.8 months (95% CI 5.4; 16.6) with lanreotide versus 11.0 (2.8; 16.9) with placebo.

    In plain wordsIn atypical carcinoids, median time without progression was 13.8 months with lanreotide versus 11.0 with placebo.

    Peptide
    Lanreotide
    Outcome
    IncreaseDouble-blind progression-free survival, atypical carcinoids
    Study

    n = 32

    Comparator
    placebo
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 28 daysAs given in this study (human).

    Measurements

    Median PFS, double-blind
    13.8 months
    lanreotide, atypical carcinoids
    95% CI of median PFS
    5.4 to 16.6 months
    lanreotide, atypical carcinoids
    Median PFS, double-blind
    11 months
    placebo, atypical carcinoids
    95% CI of median PFS
    2.8 to 16.9 months
    placebo, atypical carcinoids

    Source sentences

    Summary
    corresponding values were 21.9 (13.8; NC) and 13.9 (13.4; NC) months, respectively, in TCs and 13.8 (5.4; 16.6) and 11.0 (2.8; 16.9) months, respectively, in ACs.
    3 context sentences
    Summary · context
    SPINET (EudraCT: 2015-004992-62; NCT02683941) was a phase III, double-blind study of lanreotide autogel/depot (LAN; 120 mg every 28 days) plus best supportive care (BSC) vs placebo plus BSC, with an optional open-label treatment phase (LAN plus BSC).
    Summary · context
    Patients had metastatic/unresectable, somatostatin receptor (SSTR)-positive TCs or ACs.
    Summary · context
    Seventy-seven patients were randomized (LAN, n = 51 (TCs, n = 29; ACs, n = 22); placebo, n = 26 (TCs, n = 16; ACs, n = 10)).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In typical carcinoids, median double-blind PFS was 21.9 months (95% CI 13.8; NC) with lanreotide versus 13.9 (13.4; NC) with placebo.

    In plain wordsIn typical carcinoids, median time without progression was 21.9 months with lanreotide versus 13.9 with placebo.

    Peptide
    Lanreotide
    Outcome
    IncreaseDouble-blind progression-free survival, typical carcinoids
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 28 daysAs given in this study (human).

    Measurements

    Median progression-free survival
    21.9 months
    typical carcinoids, double-blind, lanreotide
    Median PFS 95% CI lower bound
    13.8 months
    typical carcinoids, lanreotide; upper bound not calculable (NC)
    Median progression-free survival
    13.9 months
    typical carcinoids, double-blind, placebo
    Median PFS 95% CI lower bound
    13.4 months
    typical carcinoids, placebo; upper bound not calculable (NC)

    Source sentences

    Summary
    corresponding values were 21.9 (13.8; NC) and 13.9 (13.4; NC) months, respectively, in TCs
    4 context sentences
    Summary · context
    During double-blind treatment, median (95% CI) PFS was 16.6 (11.3; 21.9) months for LAN vs 13.6 (8.3; NC) months for placebo (not significant);
    Summary · context
    SPINET (EudraCT: 2015-004992-62; NCT02683941) was a phase III, double-blind study of lanreotide autogel/depot (LAN; 120 mg every 28 days) plus best supportive care (BSC) vs placebo plus BSC, with an optional open-label treatment phase (LAN plus BSC).
    Summary · context
    Patients had metastatic/unresectable, somatostatin receptor (SSTR)-positive TCs or ACs.
    Summary · context
    Seventy-seven patients were randomized (LAN, n = 51 (TCs, n = 29; ACs, n = 22); placebo, n = 26 (TCs, n = 16; ACs, n = 10)).
  4. 04HumanNon-randomized trialEfficacy outcome

    In advanced BP-NET patients receiving lanreotide across double-blind and open-label phases, median PFS was 16.6 months (95% CI 11.3; 21.9).

    In plain wordsIn advanced BP-NET patients receiving lanreotide across both phases, median time without progression was 16.6 months.

    Peptide
    Lanreotide
    Outcome
    Not applicableProgression-free survival across treatment phases
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 28 daysAs given in this study (human).

    Measurements

    Median progression-free survival
    16.6 months
    double-blind and open-label phases, patients receiving LAN
    Median PFS 95% CI
    11.3 to 21.9 months
    patients receiving LAN

    Source sentences

    Summary
    Median (95% CI) PFS during double-blind and open-label phases in patients receiving LAN was 16.6 (11.3; 21.9) months overall (primary endpoint),
    3 context sentences
    Summary · context
    SPINET (EudraCT: 2015-004992-62; NCT02683941) was a phase III, double-blind study of lanreotide autogel/depot (LAN; 120 mg every 28 days) plus best supportive care (BSC) vs placebo plus BSC, with an optional open-label treatment phase (LAN plus BSC).
    Summary · context
    Patients had metastatic/unresectable, somatostatin receptor (SSTR)-positive TCs or ACs.
    Summary · context
    Seventy-seven patients were randomized (LAN, n = 51 (TCs, n = 29; ACs, n = 22); placebo, n = 26 (TCs, n = 16; ACs, n = 10)).
  5. 05HumanNon-randomized trialEfficacy outcome

    In typical carcinoids receiving lanreotide across both phases, median PFS was 21.9 months (95% CI 12.8, not calculable).

    In plain wordsIn typical carcinoids receiving lanreotide across both phases, median time without progression was 21.9 months.

    Peptide
    Lanreotide
    Outcome
    Not applicableProgression-free survival across phases, typical carcinoids
    Study

    n: not reported in source

    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 28 daysAs given in this study (human).

    Measurements

    Median progression-free survival
    21.9 months
    typical carcinoids receiving LAN
    Median PFS 95% CI lower bound
    12.8 months
    typical carcinoids; upper bound not calculable (NC)

    Source sentences

    Summary
    Median (95% CI) PFS during double-blind and open-label phases in patients receiving LAN was 16.6 (11.3; 21.9) months overall (primary endpoint), 21.9 (12.8, not calculable (NC)) months in TCs, and 13.8 (5.4; 16.6) months in ACs.
    3 context sentences
    Summary · context
    SPINET (EudraCT: 2015-004992-62; NCT02683941) was a phase III, double-blind study of lanreotide autogel/depot (LAN; 120 mg every 28 days) plus best supportive care (BSC) vs placebo plus BSC, with an optional open-label treatment phase (LAN plus BSC).
    Summary · context
    Patients had metastatic/unresectable, somatostatin receptor (SSTR)-positive TCs or ACs.
    Summary · context
    Seventy-seven patients were randomized (LAN, n = 51 (TCs, n = 29; ACs, n = 22); placebo, n = 26 (TCs, n = 16; ACs, n = 10)).
  6. 06HumanNon-randomized trialEfficacy outcome

    In atypical carcinoids receiving lanreotide across both phases, median PFS was 13.8 months (95% CI 5.4; 16.6).

    In plain wordsIn atypical carcinoids receiving lanreotide across both phases, median time without progression was 13.8 months.

    Peptide
    Lanreotide
    Outcome
    Not applicableProgression-free survival across phases, atypical carcinoids
    Study

    n: not reported in source

    Outcome group
    Tumor growth · Cancer
    Studied dose
    120 mg every 28 daysAs given in this study (human).

    Measurements

    Median progression-free survival
    13.8 months
    atypical carcinoids receiving LAN
    Median PFS 95% CI
    5.4 to 16.6 months
    atypical carcinoids

    Source sentences

    Summary
    Median (95% CI) PFS during double-blind and open-label phases in patients receiving LAN was 16.6 (11.3; 21.9) months overall (primary endpoint), 21.9 (12.8, not calculable (NC)) months in TCs, and 13.8 (5.4; 16.6) months in ACs.
    3 context sentences
    Summary · context
    SPINET (EudraCT: 2015-004992-62; NCT02683941) was a phase III, double-blind study of lanreotide autogel/depot (LAN; 120 mg every 28 days) plus best supportive care (BSC) vs placebo plus BSC, with an optional open-label treatment phase (LAN plus BSC).
    Summary · context
    Patients had metastatic/unresectable, somatostatin receptor (SSTR)-positive TCs or ACs.
    Summary · context
    Seventy-seven patients were randomized (LAN, n = 51 (TCs, n = 29; ACs, n = 22); placebo, n = 26 (TCs, n = 16; ACs, n = 10)).
  7. 07HumanNon-randomized trialEfficacy outcome

    In advanced BP-NET patients, quality of life did not deteriorate during the lanreotide study.

    In plain wordsIn advanced BP-NET patients, quality of life did not deteriorate during the lanreotide study.

    Peptide
    Lanreotide
    Outcome
    No significant changeQuality of life
    Study

    n: not reported in source

    Outcome group
    Quality of life · Whole body
    Studied dose
    120 mg every 28 daysAs given in this study (human).

    Source sentences

    Summary
    Patients' quality of life did not deteriorate and LAN was well tolerated.
    3 context sentences
    Summary · context
    SPINET (EudraCT: 2015-004992-62; NCT02683941) was a phase III, double-blind study of lanreotide autogel/depot (LAN; 120 mg every 28 days) plus best supportive care (BSC) vs placebo plus BSC, with an optional open-label treatment phase (LAN plus BSC).
    Summary · context
    Patients had metastatic/unresectable, somatostatin receptor (SSTR)-positive TCs or ACs.
    Summary · context
    Seventy-seven patients were randomized (LAN, n = 51 (TCs, n = 29; ACs, n = 22); placebo, n = 26 (TCs, n = 16; ACs, n = 10)).
  8. 08HumanNon-randomized trialSafety outcome

    In advanced BP-NET patients, lanreotide was well tolerated.

    In plain wordsIn advanced BP-NET patients, lanreotide was well tolerated.

    Peptide
    Lanreotide
    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    120 mg every 28 daysAs given in this study (human).

    Source sentences

    Summary
    Patients' quality of life did not deteriorate and LAN was well tolerated.
    3 context sentences
    Summary · context
    SPINET (EudraCT: 2015-004992-62; NCT02683941) was a phase III, double-blind study of lanreotide autogel/depot (LAN; 120 mg every 28 days) plus best supportive care (BSC) vs placebo plus BSC, with an optional open-label treatment phase (LAN plus BSC).
    Summary · context
    Patients had metastatic/unresectable, somatostatin receptor (SSTR)-positive TCs or ACs.
    Summary · context
    Seventy-seven patients were randomized (LAN, n = 51 (TCs, n = 29; ACs, n = 22); placebo, n = 26 (TCs, n = 16; ACs, n = 10)).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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