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

Treatment Patterns and Outcomes in GEP NET: A Retrospective Observational Cohort Study (PRIME Initiative)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastroenteropancreatic Neuroendocrine Tumor

• Study Type: Observational
• Enrollment (Estimated): 4023

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age		Baseline
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)	OS calculated as the number of weeks from the start of treatment until death.	Up to approximately 8 years
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	Baseline
Duration of Follow-up		Up to approximately 8 years
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+)	Baseline
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.	Baseline

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): June 12, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): February 25, 2027

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Lutathera; Real-world evidence; Treatment patterns
• Additional Relevant MeSH Terms: Gastro-enteropancreatic neuroendocrine tumor
• Other Study ID Numbers: CAAA601A1US16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO