Trial · NCT06784752
Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
NCT06784752, Phase 3, Recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET. Trials, record NCT06784752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06784752
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
- NCT number
- NCT06784752
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 240 participants, estimated
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Somatostatin Receptor Positive (SSTR+), Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)
- Interventions
- [177Lu]Lu-DOTA-TATE, Octreotide LAR
- First posted
- 2025-01-20
- Last updated
- 2026-09-11
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) centrally assessed by Blinded Independent Review Committee (BIRC) | After observing approximately 88 PFS events as per BIRC assessments, expected after approximately 33 months from study start | PFS is defined as the time from randomization to the first occurrence of progression (centrally assessed by Blinded Independent Review Committee (BIRC) according to RECIST v1.1) or death due to any cause. |
| Secondary | Time to Deterioration (TDD) (Key Secondary) | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | Time to deterioration is defined as the time from randomization to the first occurrence of a deterioration compared to the baseline scores or death from any cause for each of the following domains (tested separately) of EORTC QLQ-GI.NET21 \[gastrointestinal scale (GI scale)\] and EORTC QLQ-C30 questionnaires (fatigue, diarrhea, and global health scale). |
| Secondary | Progression Free Survival (PFS) | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | PFS is defined as the time from randomization to the first occurrence of progression (Investigator assessed according to RECIST v1.1) or death due to any cause. |
| Secondary | Objective Response Rate (ORR) | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | ORR: Rate of participants with best overall response (BOR) of partial response (PR) or complete response (CR) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC). |
| Secondary | Disease Control Rate (DCR) | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | DCR: Rate of participants with BOR of PR, CR or stable disease (SD) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC). |
| Secondary | Duration of Response (DOR) | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | DOR: The time from initially meeting the criteria for response (CR or PR) until the time of progression according to RECIST v1.1 or death due to underlying disease only. |
| Secondary | Overall Survival (OS) | Until 60 month from randomization | OS: Time from the randomization date until the date of death due to any cause. |
| Secondary | Time to Deterioration (TDD) | At the time of primary PFS analysis after observing approximately 88 PFS events per BIRC assessment | TTD is the time from randomization to the first occurrence of a deterioration compared to the baseline scores or death from any cause for EORTC QLQ-G.I.NET21 and EORTC QLQ-C30 domains not included among key secondary endpoints. |
| Secondary | Absolute change from baseline in EORTC QLQ-G.I.NET21 domain | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | Quality of Life assessed by EORTC QLQ-G.I.NET21 (excluding GI scale) (domains not included as key secondary objectives) |
| Secondary | Absolute change from baseline in the EQ-5D-5L index at each time point | After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start | Quality of Life assessed by EQ-5D-5L |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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/NCT06784752
GET https://conductscience.org/api/trials/v1/NCT06784752/registered