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

Novartis

Status: Not yet enrolling

Conditions: Gastroenteropancreatic Neuroendocrine Tumor

Study type: Observational

Funder types: Industry

Identifiers

NCT07635316

CAAA601A1US16

Details and patient eligibility

About

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.

Enrollment: 4,023 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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)

Trial design

4,023 participants in 7 patient groups

Overall GEP-NET Cohort

Description:

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

1L Lutetium Lu 177 Dotatate Cohort

Description:

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

1L Capecitabine + Temozolomide (CAPTEM) Cohort

Description:

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

1L Cabozantinib Cohort

Description:

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

Lutetium Lu 177 Dotatate Cohort

Description:

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

CAPTEM Cohort

Description:

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

Cabozantinib Cohort

Description:

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