ClinicalTrials.gg
RecruitingNCT07635316Updated Oct 15, 2026

A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients

An observational study in Gastroenteropancreatic Neuroendocrine Tumor, sponsored by Novartis Pharmaceuticals. Recruiting at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Updated Oct 15, 2026Primary completion movedStudy completion movedGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
4,023
Ages
18 Years to 110 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 30 studies in Gastro-enteropancreatic neuroendocrine tumor with a site in United States — 7 open to participants now, 16 under way, 5 of them phase 3. Gastro-enteropancreatic neuroendocrine tumor · United States.

Started
2026
the only one that year
Observational
8 of 30
2 open now
Primary completion
2027-06
later than 11 of 15 live
Registered
30th of 30
by date
Lead sponsor
2 of 30
Novartis Pharmaceuticals

Among the 30 studies in Gastro-enteropancreatic neuroendocrine tumor with a site in United States, this one is the only one that started in 2026, is one of 8 observational ones, reaches primary completion later than 11 of the 15 other live ones, and was the 30th registered.

Gastro-enteropancreatic neuroendocrine tumor

73 studies on the registry are indexed under Gastro-enteropancreatic neuroendocrine tumor; 25 are open to participants now.

Browse Gastro-enteropancreatic neuroendocrine tumor studies →

Open to participants now

7 of the 30 studies in Gastro-enteropancreatic neuroendocrine tumor with a site in United States are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 21 Gastro-enteropancreatic neuroendocrine tumor studies recruiting now, 13 (62%) set no upper age limit and 4 (19%) stop at 75 or younger; 2 take children under 18; none take healthy volunteers.

This study: 18 Years to 110 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Gastro-enteropancreatic neuroendocrine tumor with a site in United States, or all of them as a file.
02

Study summary

This study aims to characterize current treatment patterns and clinical outcomes among newly diagnosed GEP-NET patients in the United States using open-source Longitudinal Prescription Claims (LRx) and Patient Centric Medical Claims (Dx) databases supplemented with mortality data.

03

Conditions studied

  • Gastroenteropancreatic Neuroendocrine Tumor

Keywords

  • Real-world evidence
  • Treatment patterns
  • Lutathera
04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with evidence of a GEP-NET diagnosis between 01 January 2018 and 31 December 2025 and initiating a 1L treatment during this time period.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with ≥1 International Classification of Diseases Clinical Modification, 10th revision (ICD-10-CM) diagnosis code for GEP-NET between 01 January 2018 and 31 December 2025. The date of the first such claim will be defined as the diagnosis date.
  2. Initiation of (1L) systemic therapy (i.e., somatostatin analogs [SSAs], targeted therapy, peptide receptor radionuclide therapy [PRRT], chemotherapy) indicated for GEP-NET on or after the date of diagnosis. The date of treatment initiation will be defined as the index date.
  3. Patients ≥18 years of age on the index date
  4. Patients with ≥12 months (360 days) of continuous data availability (proxy for continuous health plan enrollment) prior to the index date, defined as:

    1. ≥1 medical and pharmacy claim >12 months prior to the index date; AND
    2. ≥1 medical and pharmacy claim within the first 6 months of the 12-month period prior to the index date; AND
    3. ≥1 medical and pharmacy claim during the last 6 months of the 12-month period prior to the index date; AND
  5. Patients with ≥1 month (30 days) of continuous data availability (proxy for continuous health plan enrollment) following the index date, defined as:

    1. ≥ 1 pharmacy dispensing a GEP-NET treatment at any time during the post-index period, including the index date, reports data during the first month following the index date
    2. ≥ 1 provider prescribing a GEP-NET treatment at any time during the post-index period, including the index date, reports data during the first month following the index date

Exclusion criteria

Exclusion criteria:

  1. Patients with evidence of GEP-NET prior to the diagnosis date within the study period
  2. Patients with evidence of GEP-NET treatment prior to the index date within the study period
  3. Patients with missing or invalid age or sex
  4. Patients with other primary during the 12-month pre-index period
  5. Patients with invalid death date (i.e., death date ≤ index date)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
4,023 participants (estimated)
Patient registry
No

Groups and cohorts

  • Overall GEP-NET Cohort

    Adult patients newly diagnosed with a GEP-NET between 01 January 2018 and 31 December 2025.

  • 1L Lutetium Lu 177 Dotatate Cohort

    A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L lutetium Lu 177 dotatate.

  • 1L Capecitabine + Temozolomide (CAPTEM) Cohort

    A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L CAPTEM.

  • 1L Cabozantinib Cohort

    A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L cabozantinib.

  • Lutetium Lu 177 Dotatate Cohort

    A subgroup of the Overall GEP-NET Cohort. Patients receiving lutetium Lu 177 dotatate in 2L or later settings.

  • CAPTEM Cohort

    A subgroup of the Overall GEP-NET Cohort. Patients receiving CAPTEM in 2L or later settings.

  • Cabozantinib Cohort

    A subgroup of the Overall GEP-NET Cohort. Patients receiving cabozantinib in 2L or later settings.

This study also gives Cabozantinib. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Number of Lines of Therapy (LOTs)

    Time frame: Up to approximately 8 years

  2. Number and Percentage of Patients by Treatment Regimen per LOT

    Time frame: Up to approximately 8 years

  3. Number and Percentage of Patients by Type of Therapy in Each LOT

    Time frame: Up to approximately 8 years

  4. Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen

    Time frame: Up to approximately 8 years

  5. Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation

    Time frame: Up to approximately 8 years

  6. Time to 1L Treatment Discontinuation

    Time frame: Up to approximately 8 years

Secondary outcomes

  1. Duration Between GEP-NET Diagnosis and 1L Treatment

    Time frame: Baseline

  2. Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment

    Time frame: Up to approximately 8 years

  3. Number and Percentage of Patients With Addition of Other Therapies While on Initial 1L Therapy

    Time frame: Up to approximately 8 years

  4. Time to Next Treatment (TTNT)

    Time frame: Up to approximately 8 years

  5. Overall Survival (OS)

    OS calculated as the number of weeks from the start of treatment until death.

    Time frame: Up to approximately 8 years

  6. Number and Percentage of Patients by Demographics

    Demographics include: * Age group (18-34, 35-44, 45-54, 55-64, 65+ years) * Sex * Geographic region * Payer type * Race/ethnicity * Education level * Occupation * Marital status

    Time frame: Baseline

  7. Age

    Time frame: Baseline

  8. Duration of Follow-up

    Time frame: Up to approximately 8 years

  9. Number and Percentage of Patients by Clinical Characteristics

    Clinical characteristics include: * National Cancer Institute (NCI) comorbidity index category (0, 1, 2, 3+) * Comorbidities * Treating provider specialty * Metastatic sites (bone, visceral, lymph node, liver) * Number of distinct metastatic sites (0, 1, 2, 3, 4+)

    Time frame: Baseline

  10. NCI Comorbidity Index Score

    The NCI comorbidity index is a tool used to measure the risk of non-cancer deaths for cancer patients based on the presence and severity of other health conditions. It includes 14 conditions identified using administrative data diagnosis and procedure codes. The index excludes solid tumors, leukemias, and lymphomas as comorbid conditions. Each condition is assigned a score (from 1 to 6) based on how serious it is and patient scores are summed to give a final overall score. A high score indicates a higher burden of comorbid conditions and possible higher risk of death.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: primary completion Feb 2027 → Jun 2027 and completion Feb 2027 → Jun 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2026
First posted
Jun 9, 2026
StartActual
Jun 12, 2026
Primary completionEst.
Jun 30, 2027was Feb 2027
CompletionEst.
Jun 30, 2027was Feb 2027
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Feb 25, 2027→Jun 30, 2027
Oct 15, 2026
Study completion
Feb 25, 2027→Jun 30, 2027
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Primary completion Feb 25, 2027→Jun 30, 2027
    Study completion Feb 25, 2027→Jun 30, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07635316
Responsible party
Sponsor
First posted
Jun 9, 2026
Start date
Jun 12, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
+41613241111
Novartis Pharmaceuticals
Contact
Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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