Trial · NCT04852679
Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
NCT04852679, Phase 3, Completed, Ipsen; results first posted 2024-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs. Trials, record NCT04852679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04852679
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
- NCT number
- NCT04852679
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 43 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Gastroenteropancreatic Neuroendocrine Tumor
- Interventions
- Lanreotide autogel
- First posted
- 2021-04-21
- Last updated
- 2024-10-01
- Results first posted
- 2024-10-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 | The CBR was defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR), or continued stable disease (SD) until the time of assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. |
| Secondary | Progression Free Survival (PFS) by BICR Within Weeks 24 and 48 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 | The PFS was defined as the time from the first administration of study intervention to the date of the first documented PD measured using RECIST criteria v1.1 and confirmed by BICR, or death from any cause, whichever comes first. The PFS was estimated using the Kaplan-Meier method. The PD was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Survival (OS) at the End of the Main Intervention Period | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period) | The OS was defined as the time from the first administration of study intervention to the date of death from any cause. The OS was estimated using the Kaplan-Meier method. |
| Secondary | Time to Progression (TTP) During Main Intervention Period | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 | The TTP was defined as the time from the first administration of study intervention to the date of the first documented PD, or clinical progression confirmed by the investigator. The TTP was assessed by BICR and estimated using the Kaplan-Meier method. The PD was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 | Percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 24 and 48 weeks after first dose of study intervention were reported. The PFS was estimated using the Kaplan-Meier method. The PD was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Clinical Benefit Rate Assessed by BICR at Week 48 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 | The CBR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or continued SD until the time of assessment according to RECIST criteria v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. |
| Secondary | Overall Response Rate (ORR) at Weeks 24 and 48 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 | The ORR was defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. |
| Secondary | Disease Control Rate (DCR) at Weeks 24 and 48 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 | The DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR or SD. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. |
| Secondary | Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48 | Weeks 24 and 48 | The presence or absence of endocrine symptoms of NETs (example; flushing, diarrhoea, abdominal pain, weakness, heartburn, nausea, vomiting, sweating, tremor, palpitation, or erythema) were assessed by the investigator at screening. In participants with symptoms of NETs at screening, a baseline assessment of the symptoms experienced in the last 4 weeks was performed by questioning before study intervention administration at Day 1. These symptoms were recorded in the case report form and severity graded upon National Cancer Institute Common Terminology Criteria for Adverse Events. Where, Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death. |
| Secondary | Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48 | Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 | The CgA determination was useful for staging, prognosis and follow up, since the serum concentration correlated to the tumour mass. Blood samples were collected to measure circulating CgA. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 | The ITT analysis set included all participants who received at least 1 dose of study intervention. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) by BICR Within Weeks 24 and 48 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 | The ITT analysis set included all participants who received at least 1 dose of study intervention. | weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) at the End of the Main Intervention Period | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period) | The ITT analysis set included all participants who received at least 1 dose of study intervention. | weeks | MEDIAN |
| SECONDARY | Time to Progression (TTP) During Main Intervention Period | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 | The ITT analysis set included all participants who received at least 1 dose of study intervention. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 | The ITT analysis set included all participants who received at least 1 dose of study intervention. | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate Assessed by BICR at Week 48 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 | The ITT analysis set included all participants who received at least 1 dose of study intervention. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) at Weeks 24 and 48 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 | The ITT analysis set included all participants who received at least 1 dose of study intervention. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) at Weeks 24 and 48 | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 | The ITT analysis set included all participants who received at least 1 dose of study intervention. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48 | Weeks 24 and 48 | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48 | Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 | The ITT analysis set included all participants who received at least 1 dose of study intervention. | microgram per liter | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24 | Lanreotide Autogel 120 mg | 62.79 | 95% Confidence Interval 46.7 to 77.0 | percentage of participants | |
| Progression Free Survival (PFS) by BICR Within Weeks 24 and 48 | Lanreotide Autogel 120 mg | Week 24 | NA | 95% Confidence Interval 24.1 to NA | weeks |
| Progression Free Survival (PFS) by BICR Within Weeks 24 and 48 | Lanreotide Autogel 120 mg | Week 48 | NA | 95% Confidence Interval 36.1 to NA | weeks |
| Overall Survival (OS) at the End of the Main Intervention Period | Lanreotide Autogel 120 mg | NA | 95% Confidence Interval NA to NA | weeks | |
| Time to Progression (TTP) During Main Intervention Period | Lanreotide Autogel 120 mg | NA | 95% Confidence Interval 48.0 to NA | weeks | |
| Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48 | Lanreotide Autogel 120 mg | Week 24 | 77.4 | 95% Confidence Interval 59.6 to 88.1 | percentage of participants |
| Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48 | Lanreotide Autogel 120 mg | Week 48 | 59.0 | 95% Confidence Interval 36.1 to 76.1 | percentage of participants |
| Clinical Benefit Rate Assessed by BICR at Week 48 | Lanreotide Autogel 120 mg | 58.1 | 95% Confidence Interval 42.1 to 73.0 | percentage of participants | |
| Overall Response Rate (ORR) at Weeks 24 and 48 | Lanreotide Autogel 120 mg | Week 24 | 0 | 95% Confidence Interval 0.0 to 8.2 | percentage of participants |
| Overall Response Rate (ORR) at Weeks 24 and 48 | Lanreotide Autogel 120 mg | Week 48 | 7.0 | 95% Confidence Interval 1.5 to 19.1 | percentage of participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Intervention Period | STARTED | Lanreotide Autogel 120 Milligram (mg) | 43 | |
| Main Intervention Period | Study Intervention Completion at Week 24 | Lanreotide Autogel 120 Milligram (mg) | 28 | |
| Main Intervention Period | COMPLETED | Lanreotide Autogel 120 Milligram (mg) | 22 | |
| Main Intervention Period | NOT COMPLETED | Lanreotide Autogel 120 Milligram (mg) | 21 | |
| Independent Injection Period | STARTED | Lanreotide Autogel 120 Milligram (mg) | 5 | |
| Independent Injection Period | COMPLETED | Lanreotide Autogel 120 Milligram (mg) | 4 | |
| Independent Injection Period | NOT COMPLETED | Lanreotide Autogel 120 Milligram (mg) | 1 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Main Intervention Period: Lanreotide Autogel 120 mg | 9 | 43 | 10 |
| other | Alanine aminotransferase increased | Investigations | Independent Injection Period: Lanreotide Autogel 120 mg | 0 | 5 | 0 |
| other | Bilirubin conjugated increased | Investigations | Main Intervention Period: Lanreotide Autogel 120 mg | 8 | 43 | 8 |
| other | Bilirubin conjugated increased | Investigations | Independent Injection Period: Lanreotide Autogel 120 mg | 0 | 5 | 0 |
| other | Blood bilirubin increased | Investigations | Main Intervention Period: Lanreotide Autogel 120 mg | 8 | 43 | 9 |
| other | Blood bilirubin increased | Investigations | Independent Injection Period: Lanreotide Autogel 120 mg | 0 | 5 | 0 |
| other | Weight decreased | Investigations | Main Intervention Period: Lanreotide Autogel 120 mg | 8 | 43 | 10 |
| other | Weight decreased | Investigations | Independent Injection Period: Lanreotide Autogel 120 mg | 0 | 5 | 0 |
| other | Blood glucose increased | Investigations | Main Intervention Period: Lanreotide Autogel 120 mg | 7 | 43 | 7 |
| other | Blood glucose increased | Investigations | Independent Injection Period: Lanreotide Autogel 120 mg | 0 | 5 | 0 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Main Intervention Period: Lanreotide Autogel 120 mg | 2 | 43 |
| Total, all-cause mortality | Independent Injection Period: Lanreotide Autogel 120 mg | 0 | 5 |
| Total, other adverse events | Main Intervention Period: Lanreotide Autogel 120 mg | 43 | 43 |
| Total, other adverse events | Independent Injection Period: Lanreotide Autogel 120 mg | 2 | 5 |
| Total, serious adverse events | Main Intervention Period: Lanreotide Autogel 120 mg | 4 | 43 |
| Total, serious adverse events | Independent Injection Period: Lanreotide Autogel 120 mg | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Main Intervention Period: Lanreotide Autogel 120 mg vs Independent Injection Period: Lanreotide Autogel 120 mg: deaths from any cause | Trial comparisons |
| Main Intervention Period: Lanreotide Autogel 120 mg vs Independent Injection Period: Lanreotide Autogel 120 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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