Tandem therapy LutaPol/ltraPol ( I 77Lu / 90Y-DOTATATE) as an effective method in the treatment of neuroendocrine neoplasmas.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Narodowe Centrum Badan Jadrowych

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-01-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2024-516503-17-01

EudraCT number

2020-006068-99

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Dose response, Therapy

The aim of the study is to develop an algorithm for the treatment of GEPNET patients using ItraPol and LutaPol isotope mixtures (177Lu-DOTATATE and 90Y-DOTATATE) based on personalized dosimetry.

Secondary objectives 1

1. The specific goal is to assess the effectiveness and safety of personalized treatment of GEP-NET patients using 177Lu-DOTATATE and 90Y-Lu- DOTATATE mixtures compared to standard treatment of NEN patients using 177Lu-DOTATATE

Conditions and MedDRA coding

Diagnosed and histopathologically confirmed diffuse or locally unresectable, well and intermediate differentiated neuroendocrine tumour of the gastrointestinal tract

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Associated with neuroendocrine tumour: a)Presence of advanced, unresectable, histopathologically confirmed well and intermediate differentiated (G1 and G2) neuroendocrine tumour with high expression of somatostatin receptors on somatostatin receptor imaging (SRI) PET/CT with 68Ga-DOTA-TATE performed up to 12 weeks prior to first administration of therapy b)Detection of tumour progression according to RECIST criteria 1. 1 on multiphasic CT or dynamic MR imaging within 18 months, with a qualifying study performed up to 12 weeks prior to the first administration of therapy c)Laboratory tests*: ◦ Blood count with smear Hb > 9g/dl, platelets > 100,000/μl, leukocytes > 3,000/μl, neutrocytes > 1.5,000/μl, ◦ Creatinine <120 μmol/l (1.36 mg/dl) or eGFR>45 ml/min. ◦ ALT, AspAT, total bilirubin (values not exceeding 3x the reference standard) **it is acceptable to use for qualification the results of biochemical and haematological tests that are part of the medical history if they were performed up to 12 weeks before the qualifying visit and if, in the opinion of the investigator, there is no need and no indication to repeat them Patient-related: Patient's overall Karnofsky score ≥60%. Expected survival of more than 6 months. Age over 18 years, with no upper age limit. Ability to give informed consent to participate in the study. Signing an informed consent form to participate in the study.

Exclusion criteria 1

1. Cancer-related: Patient disability (Karnofsky <60) Expected survival of less than 6 months. Treatment for another malignancy less than 5 years prior to randomisation. Associated with current and past medical therapies and interventions: PRRT in the past. Chemotherapy or molecular treatment (for NEN or other cancer) in the past. Patient-related: Age under 18 years. Pregnancy or breastfeeding. Patients with impaired bladder outflow or untreated urinary incontinence without catheter protection. Lack of capacity to give informed consent to participate in the study. Failure to sign an informed consent form to participate in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease progression assessed by CT or MRI according to RECIST 1.1. Timepoints of Primary End Point evaluation: control imaging investigations (CT or MRI) using the technique identical with the one based on which the patient was qualified for the trial, performed after 3,6,12,24,36,49,60 months after completion of therapy with assessment according to RECIST 1.1

Secondary endpoints 1

1. Assessment of effectiveness and safety of personalized therapy. It is planned to perform biochemical tests during visit W1, during hospitalization and in the course of observation every 3 months (tests of blood morphology, urea, creatinine, eGFR, bilirubin). Total volume of blood collected at single timepoint - 6.8 ml.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Narodowe Centrum Badan Jadrowych

Sponsor organisation

Narodowe Centrum Badan Jadrowych

Address

Ul. Andrzeja Soltana 7

City

Otwock

Postcode

05-400

Country

Poland

Scientific contact point

Organisation

Narodowe Centrum Badan Jadrowych

Contact name

Sponsor

Public contact point

Organisation

Narodowe Centrum Badan Jadrowych

Contact name

Sponsor

Third parties 1

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications