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

ConditionGastroenteropancreatic Neuroendocrine Tumor
Trial statusRecruiting
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

Sponsors and contacts

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

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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