Continuing Somatostatin Analogues Upon progression in Neuroendocrine tumour pAtients (SAUNA trial)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Antwerp University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]

Trial duration

28 Jun 2023 → ongoing

Decision date (initial)

2023-05-31

Transition trial

No

Low-intervention

Yes

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

ZonMw (the Netherlands) · Belgian Health Care Knowledge Centre (Belgium)

External identifiers

EU CT number

2022-502703-30-00

ClinicalTrials.gov

NCT05701241

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

First co-primary objective: to assess the difference in progression-free survival (PFS) per substudy between patients continuing or stopping SSA, as assessed by blinded local radiologists on cross-sectional imaging; progression is defined through Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 standardised framework after initiating second-line therapy with PRRT (substudy 1) or targeted therapy (substudy 2).

Second co-primary objective: to assess the difference in time to deterioration (TTD) after initiating second-line therapy per substudy. TTD is defined as time from randomization to the first decrease from baseline on the Global Health component of the EORTC QLQ-C30 questionnaire by at least 10 points (on an 100-point scale), with no further increase above this threshold, or death.

Secondary objectives 8

1. To assess PFS according to RECIST 1.1 at 18 months per substudy
2. To assess the difference in pooled PFS and TTD of both substudies
3. To assess overall survival (OS) per substudy and pooled over both substudies
4. To assess response rates per substudy and pooled over both substudies
5. To assess quality of life
6. To assess cost-effectiveness
7. To assess toxicity
8. To analyze relevant biomarkers in a subset of subjects (exploratory objective)

Conditions and MedDRA coding

neuroendocrine tumours

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age ≥18 years
2. Written informed consent prior to any study-related procedures
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
4. Histologically-proven diagnosis of locally advanced or metastatic, non-functional, well-differentiated WHO 2019 grade 1‒2 GEP NET
5. Documented radiological disease progression on first-line SSA treatment
6. For targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigator
7. For PRRT substudy: indication to start with PRRT with 177Lu-DOTATATE as second-line therapy, according to local investigator

Exclusion criteria 10

1. Indication for chemotherapy treatment of GEP NET in second-line
2. Presence of poorly differentiated grade 3 NEC, well-differentiated grade 3 NET or rapidly progressive NET
3. Prior treatment with everolimus, sunitinib or PRRT
4. Contra-indication, proven allergy or other indication than functional NET for the use of a SSA
5. Patient showing progressive disease while being on a lower than the registered dose
6. Functional NET, defined as the presence of clinical and biochemical evidence of a hormonal NET-related syndrome
7. Patient undergoing palliative, systemic oncological treatment for other malignancy than GEP NET
8. Concurrent anti-cancer treatment in another investigational trial
9. Any abnormal findings at baseline, clinical finding, including psychiatric and behavioural problems, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study
10. Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. The difference in PFS between patients continuing or stopping SSA after initiating PRRT, as assessed by blinded local radiologists on cross-sectional imaging; progression is defined through RECIST 1.1 standardized framework.
2. The difference in PFS between patients continuing or stopping SSA after initiating targeted therapy, as assessed by blinded local radiologists on cross-sectional imaging; progression is defined through RECIST 1.1 standardized framework.
3. The difference in TTD in patients continuing or stopping second-line therapy with SSAs after initiating PRRT.
4. The difference in TTD in patients continuing or stopping second-line therapy with SSAs after initiating targeted therapy.

Secondary endpoints 7

1. PFS rate according to RECIST 1.1 at 18 months per substudy
2. The difference in pooled PFS and TTD of both substudies
3. Overall survival per substudy and pooled over both substudies
4. Response rates per substudy and pooled over both substudies
5. Quality of life (QoL)
6. Cost-effectiveness
7. Toxicity

Investigational products

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

Test 2

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Antwerp University Hospital

Sponsor organisation

Antwerp University Hospital

Address

Drie Eikenstraat 655

City

Edegem

Postcode

2650

Country

Belgium

Scientific contact point

Organisation

Antwerp University Hospital

Contact name

Timon Vandamme

Public contact point

Organisation

Antwerp University Hospital

Contact name

Iris Verhaegen

Locations

2 EU/EEA countries · 22 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 39 files

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

Application history

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