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RecruitingNCT07635316Updated Jul 6, 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 2026-07-06.

Sponsored by Novartis Pharmaceuticals · Observational

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

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.

02

Conditions studied

  • Gastroenteropancreatic Neuroendocrine Tumor

Keywords

  • Real-world evidence
  • Treatment patterns
  • Lutathera
03

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.

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 first-line (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 malignancies during the 12-month pre-index period
  5. Patients with invalid death date (i.e., death date ≤ index date)
04

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.

05

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

06

Study locations

1 of 1 sites recruiting
  • Novartis
    East Hanover, New Jersey 07936, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07635316
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jun 9, 2026
Start date
Jun 12, 2026
Primary completion
Feb 25, 2027 (estimated)
Completion
Feb 25, 2027 (estimated)
Last update
Jul 6, 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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