Recruiting

Observational Study

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07635316

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

Study ID

NCT07635316

Start date

Jun 12, 2026

Status verified date

Jul, 2026

Completion date

Feb 25, 2027

Anticipated

Primary completion date

Feb 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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:

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)

Study Design

Enrollment

4023 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Number of Lines of Therapy (LOTs) [ Time Frame: Up to approximately 8 years ]
  • Number and Percentage of Patients by Treatment Regimen per LOT [ Time Frame: Up to approximately 8 years ]
  • Number and Percentage of Patients by Type of Therapy in Each LOT [ Time Frame: Up to approximately 8 years ]
  • Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen [ Time Frame: Up to approximately 8 years ]
  • Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation [ Time Frame: Up to approximately 8 years ]
  • Time to 1L Treatment Discontinuation [ Time Frame: Up to approximately 8 years ]

Central Contacts and Locations

Central contacts

Locations

Novartis

Recruiting

East Hanover, New Jersey, United States, 07936

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Real-world evidence
  • Treatment patterns
  • Lutathera

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-06.