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

NCT07635316 | Recruiting

• 1 other identifier: CAAA601A1US16
• Study Type: observational
• Target: 4,023
• Locations: 1 country
• Sites: 1

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

Keywords

Real-world evidence; Treatment patterns; Lutathera

Outcome Measures

Primary Outcomes (6)

• Number of Lines of Therapy (LOTs)

  Up to approximately 8 years

• Number and Percentage of Patients by Treatment Regimen per LOT

  Up to approximately 8 years

• Number and Percentage of Patients by Type of Therapy in Each LOT

  Up to approximately 8 years

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

  Up to approximately 8 years

• Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation

  Up to approximately 8 years

• Time to 1L Treatment Discontinuation

  Up to approximately 8 years

Secondary Outcomes (10)

• Duration Between GEP-NET Diagnosis and 1L Treatment

  Baseline

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

  Up to approximately 8 years

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

  Up to approximately 8 years

• Time to Next Treatment (TTNT)

  Up to approximately 8 years

• Overall Survival (OS)

  Up to approximately 8 years

Study Arms (7)

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.

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.
• Patients ≥18 years of age on the index date
• Patients with ≥12 months (360 days) of continuous data availability (proxy for continuous health plan enrollment) prior to the index date, defined as:
• ≥1 medical and pharmacy claim \>12 months prior to the index date; AND
• ≥1 medical and pharmacy claim within the first 6 months of the 12-month period prior to the index date; AND
• ≥1 medical and pharmacy claim during the last 6 months of the 12-month period prior to the index date; AND
• Patients with ≥1 month (30 days) of continuous data availability (proxy for continuous health plan enrollment) following the index date, defined as:
• ≥ 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
• ≥ 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

You may not qualify if:

• Patients with evidence of GEP-NET prior to the diagnosis date within the study period
• Patients with evidence of GEP-NET treatment prior to the index date within the study period
• Patients with missing or invalid age or sex
• Patients with other primary malignancies during the 12-month pre-index period
• Patients with invalid death date (i.e., death date ≤ index date)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 9, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): February 25, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)