Post-Authorization Long-Term Safety Study of LUTATHERA | NCT03691064

ID	Type	Description	Link
CAAA601A12402	Other Identifier	Novartis
EUPAS25735	Other Identifier	ENCePP

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 28, 2018Actual

Primary Completion Date

Sep 30, 2027Estimated

Completion Date

Sep 30, 2027Estimated

First Submitted Date

Sep 22, 2018

First Submission Date that Met QC Criteria

Sep 25, 2018

First Posted Date

Oct 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2025

Last Update Posted Date

Dec 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).

Detailed Description

To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,014Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LUTATHERA		Treated per labeled LUTATHERA dosing regimen.	Drug: LUTATHERA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LUTATHERA	Drug	Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie [mCi]) every 8 weeks for a total of 4 doses.	LUTATHERA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
secondary cancers: incidence of secondary cancers	incidence of secondary cancers	up to 7 years follow-up

Secondary Outcomes

Measure	Description	Time Frame
safety profile: incidence of adverse events	incidence of adverse events	up to 7 years follow-up
mortality	mortality (all cause)	up to 7 years follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients (fulfilling the definition of "age of majority" per local regulations),
with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs
and who were treated with Lutathera (regardless of the quantity and number of doses administered and whatever the reasons for ending).

Exclusion Criteria:

Hypersensitivity to Lutathera (active substance or any of the excipients),
presence of established or suspected pregnancy or pregnancy not excluded,
presence of kidney failure with creatinine clearance < 30 mL/min.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients treated with LUTATHERA for the labeled indication using the approved dosing regimen.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Study Director	Advanced Accelerator Applications	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banner MD Anderson Cancer Center		Phoenix	Arizona	85006	United States
The Ohio State University Wexner Medical Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue