Trial · NCT03972488
Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
NCT03972488, Phase 3, Active not recruiting, Advanced Accelerator Applications; results first posted 2024-10-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET. Trials, record NCT03972488. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03972488
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
- NCT number
- NCT03972488
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 226 participants, actual
- Lead sponsor
- Advanced Accelerator Applications
- Conditions
- Gastro-enteropancreatic Neuroendocrine Tumor
- Interventions
- Lutathera, 30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot), 2.5% Lys-Arg sterile amino acid solution, High dose 60 mg octreotide long-acting repeatable
- First posted
- 2019-06-03
- Last updated
- 2026-01-21
- Results first posted
- 2024-10-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Per Central Assessment | from randomization to the first line progression or death due to any cause, up to approx. 42 months | PFS is the time from randomization to the first line progression (centrally assessed according to RECIST 1.1) or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumor Criteria (RECIST 1.1) as a 20% increase in the sum of diameters of all measured target lesions or unequivocal progression of non-target lesions or appearance of a new lesion. |
| Secondary | Overall Response Rate (ORR) Per Central Assessment (Key Secondary) | Up to approx. 42 months | ORR is defined as the percentage of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Time to Deteriration (TTD) Global Health Status, Diarrhea, Fatigue, Pain (EORTC QLQ-C30) (Key Secondary) | Up to approx. 42 months | TTD is defined as the first deterioration of at least 10 points from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): global health status, diarrhea, fatigue, and pain. The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Raw scores are linearly transformed so each score ranged a 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement). |
| Secondary | Disease Control Rate (DCR) Per Central Assessment | Up to approx. 42 months | Disease Control Rate is the percentage of participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) (centrally assessed according to RECIST 1.1). CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD). |
| Secondary | Duration of Response (DOR) Per Central Assessment | Up to approx. 42 months | Duration of Response defined as time from first complete or partial response to progression or death due to underlying cancer according to RECIST 1.1. |
| Secondary | Rate of Adverse Events | from FPFV until end of study (about 94 months) | Rate of adverse events scored according to CTCAE grade |
| Secondary | Rate of Laboratory Toxicities | from FPFV until end of study (about 94 months) | Rate of laboratory toxicities scored according to CTCAE grade |
| Secondary | Overall Survival (OS) | from FPFV until end of study (about 94 months) | OS is the time from randomization date until day of death due to any cause. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) Per Central Assessment | from randomization to the first line progression or death due to any cause, up to approx. 42 months | Full Analysis Set (FAS) comprises all participants to whom study treatment has been assigned by randomization. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) Per Central Assessment (Key Secondary) | Up to approx. 42 months | FAS comprises all participants to whom study treatment has been assigned by randomization. | Percentage of participants | NUMBER |
| SECONDARY | Time to Deteriration (TTD) Global Health Status, Diarrhea, Fatigue, Pain (EORTC QLQ-C30) (Key Secondary) | Up to approx. 42 months | FAS comprises all participants to whom study treatment has been assigned by randomization. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Per Central Assessment | Up to approx. 42 months | FAS comprises all participants to whom study treatment has been assigned by randomization. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per Central Assessment | Up to approx. 42 months | FAS comprises all participants to whom study treatment has been assigned by randomization. Only participants who had a response were analyzed. | months | MEDIAN |
| SECONDARY | Rate of Adverse Events | from FPFV until end of study (about 94 months) | |||
| SECONDARY | Rate of Laboratory Toxicities | from FPFV until end of study (about 94 months) | |||
| SECONDARY | Overall Survival (OS) | from FPFV until end of study (about 94 months) |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) Per Central Assessment | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 22.8 | 95% Confidence Interval 19.4 to NA | months | |
| Progression Free Survival (PFS) Per Central Assessment | Octreotide LAR 60 mg (Control Arm) | 8.5 | 95% Confidence Interval 7.7 to 13.8 | months | |
| Overall Response Rate (ORR) Per Central Assessment (Key Secondary) | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 43.0 | 95% Confidence Interval 35.0 to 51.3 | Percentage of participants | |
| Overall Response Rate (ORR) Per Central Assessment (Key Secondary) | Octreotide LAR 60 mg (Control Arm) | 9.3 | 95% Confidence Interval 3.8 to 18.3 | Percentage of participants | |
| Time to Deteriration (TTD) Global Health Status, Diarrhea, Fatigue, Pain (EORTC QLQ-C30) (Key Secondary) | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | Global Health status | 13.2 | 95% Confidence Interval 8.8 to 17.2 | months |
| Time to Deteriration (TTD) Global Health Status, Diarrhea, Fatigue, Pain (EORTC QLQ-C30) (Key Secondary) | Octreotide LAR 60 mg (Control Arm) | Global Health status | 8.6 | 95% Confidence Interval 5.8 to 14.0 | months |
| Time to Deteriration (TTD) Global Health Status, Diarrhea, Fatigue, Pain (EORTC QLQ-C30) (Key Secondary) | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | Diarrhea | 17.4 | 95% Confidence Interval 14.4 to 28.2 | months |
| Time to Deteriration (TTD) Global Health Status, Diarrhea, Fatigue, Pain (EORTC QLQ-C30) (Key Secondary) | Octreotide LAR 60 mg (Control Arm) | Diarrhea | 17.3 | 95% Confidence Interval 8.1 to NA | months |
| Time to Deteriration (TTD) Global Health Status, Diarrhea, Fatigue, Pain (EORTC QLQ-C30) (Key Secondary) | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | Fatigue | 6.0 | 95% Confidence Interval 3.4 to 6.8 | months |
| Time to Deteriration (TTD) Global Health Status, Diarrhea, Fatigue, Pain (EORTC QLQ-C30) (Key Secondary) | Octreotide LAR 60 mg (Control Arm) | Fatigue | 6.0 | 95% Confidence Interval 3.9 to 11.0 | months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 151 | |
| Overall Study | STARTED | Octreotide LAR 60 mg (Control Arm) | 75 | |
| Overall Study | Participants Treated in Treatment Period | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 147 | |
| Overall Study | Participants Treated in Treatment Period | Octreotide LAR 60 mg (Control Arm) | 73 | |
| Overall Study | Participants Not Treated in Treatment Period | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 4 | |
| Overall Study | Participants Not Treated in Treatment Period | Octreotide LAR 60 mg (Control Arm) | 2 | |
| Overall Study | Participants Entered Crossover Treatment Period | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 0 | |
| Overall Study | Participants Entered Crossover Treatment Period | Octreotide LAR 60 mg (Control Arm) | 29 | |
| Overall Study | Participants Entered Retreatment Period | Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 8 | |
| Overall Study | Participants Entered Retreatment Period | Octreotide LAR 60 mg (Control Arm) | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events464
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 | Anaemia | Blood and lymphatic system disorders | Lutathera® Plus Octreotide LAR 30 mg | 27 | 147 | |
| other | Anaemia | Blood and lymphatic system disorders | Octreotide LAR 60 mg (Control Arm) | 4 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | Crossover Lutathera | 2 | 29 | |
| other | Anaemia | Blood and lymphatic system disorders | Re-Treatment Lutathera | 0 | 8 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Lutathera® Plus Octreotide LAR 30 mg | 9 | 147 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Octreotide LAR 60 mg (Control Arm) | 0 | 73 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Crossover Lutathera | 1 | 29 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Re-Treatment Lutathera | 0 | 8 | |
| other | Neutropenia | Blood and lymphatic system disorders | Lutathera® Plus Octreotide LAR 30 mg | 4 | 147 | |
| other | Neutropenia | Blood and lymphatic system disorders | Octreotide LAR 60 mg (Control Arm) | 0 | 73 |
1 to 10 of 464Source ClinicalTrials.gov
See all 464 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lutathera® Plus Octreotide LAR 30 mg | 32 | 147 |
| Total, all-cause mortality | Octreotide LAR 60 mg (Control Arm) | 14 | 73 |
| Total, all-cause mortality | Crossover Lutathera | 3 | 29 |
| Total, all-cause mortality | Re-Treatment Lutathera | 0 | 8 |
| Total, other adverse events | Lutathera® Plus Octreotide LAR 30 mg | 129 | 147 |
| Total, other adverse events | Octreotide LAR 60 mg (Control Arm) | 65 | 73 |
| Total, other adverse events | Crossover Lutathera | 22 | 29 |
| Total, other adverse events | Re-Treatment Lutathera | 6 | 8 |
| Total, serious adverse events | Lutathera® Plus Octreotide LAR 30 mg | 30 | 147 |
| Total, serious adverse events | Octreotide LAR 60 mg (Control Arm) | 15 | 73 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT03972488
GET https://conductscience.org/api/trials/v1/NCT03972488/events?page=2