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

ConditionGastroenteropancreatic Neuroendocrine Tumor
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

≥1 medical and pharmacy claim >12 months prior to the index date; AND

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

4,023 Participants
are grouped into 7 trial groups

7

Trial groups

See each trial group below.

Group A: Overall GEP-NET Cohort
Group B: 1L Lutetium Lu 177 Dotatate Cohort
Group C: 1L Capecitabine + Temozolomide (CAPTEM) Cohort
Group D: 1L Cabozantinib Cohort
Group E: Lutetium Lu 177 Dotatate Cohort
Group F: CAPTEM Cohort
Group G: Cabozantinib Cohort

Trial outcomes

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: