A Study to Evaluate the Value of Circulating Tumour DNA in Follow-up of Patients With an Advanced Gastroenteropancreatic or Lung Neuroendocrine Tumour Under Everolimus +- SSA Treatment (Liquid-NET 2.0)

NCT05268952 | Unknown

• 1 other identifier: Liquid-NET 2.0
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

Prospective, multicentric, single arm, POC study to evaluate the value of CtDNA in follow-up of patients treated with everolimus, with or without somatostatin analogues for advanced gastroenteropancreatic or lung neuroendocrine tumours.

Conditions

Neuroendocrine Tumors

Keywords

Liquid biopsies

Outcome Measures

Primary Outcomes (1)

• Feasibility of treatment follow-up through CtDNA level measurement

  Feasibility of treatment follow-up through detection of a change in CtDNA levels before progression is apparent on imaging according to RECIST 1.1 and/or PERCIST 1.0 (if available) (Progression-free survival (PFS)).

  48 months

Secondary Outcomes (4)

• PFS under everolimus ± SSA treatment

  48 months

• Overall response rates under everolimus ± SSA treatment

  48 months

• Safety of everolimus ± SSA treatment according to the Common Terminology Criteria for Adverse Events 4 (CTCAE4) and in Belgium according to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  48 months

• Comparison of PFS based on RECIST 1.1 and PERCIST 1.0

  48 months

Study Arms (1)

GEP-NET and lung-NET patients

EXPERIMENTAL

Liquid biopsies and scans

Other: Liquid biopsies; Other: Scans (CT, gallium-68 DOTATE/TOC/NOC PET-CT)

Interventions

Liquid biopsies OTHER

Blood/urine sampling and scans are done at regular intervals

GEP-NET and lung-NET patients

Scans (CT, gallium-68 DOTATE/TOC/NOC PET-CT) OTHER

Scans will be done at regular intervals

GEP-NET and lung-NET patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Written informed consent prior to any study-related procedure
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Histological proven diagnosis of a well or moderately differentiated GEP-NET (WHO2017 grade 1,2,3 neuroendocrine tumour)
• Documented progressive gastroenteropancreatic or lung neuroendocrine tumour by means of imaging and based upon the RECIST 1.1 criteria and/or PERCIST 1.0 criteria (if available) for which the treating physician has decided to treat with everolimus ± SSA treatment
• Presenting a positive CT and/or DOTANOC scan (at physician's discretion) at study entry with a measurable tumour lesion \> 1 cm (CT scan with a maximum slice thickness of 5 mm); baseline CT and/or DOTANOC scan performed up to 28 days prior start of treatment NO previous treatment with everolimus
• Adequate bone marrow and coagulation function as shown by:
• Haemoglobin ≥ 9.0 g/dL
• ANC ≥ 1,500/mm3 (≥1.5 x 109/L)
• Platelets ≥ 100,000/mm3 (≥ 100x 109/L)
• INR ≤ 2.0
• Adequate liver function as shown by:
• Alanine aminotransferase and aspartate aminotransferase ≤2.5xULN (Upper limit of normal) (or ≤ 5 if hepatic metastases are present)
• Total serum bilirubin ≤ 1.5 x ULN (≤ 3 ULN for patients known to have Gilbert Syndrome)
• Adequate renal function as shown by Serum creatinine≤ 1.5 x ULN

You may not qualify if:

• Patients with only non-measurable lesions by CT
• Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin) or other contra-indications for everolimus ± SSA treatment
• Unavailable archival tissue and patient unwilling to have a new biopsy
• Prior treatment with everolimus
• History of drug hypersensitivity with a similar chemical structure to lanreotide Autogel 120mg, sandostatin LAR or everolimus
• Unresolved Grade 3 or 4 toxicity from prior therapy, including experimental therapy
• History or clinical evidence of other malignancy within 3 years prior to enrolment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
• Major surgery within 4 weeks of first dose administration
• History of symptomatic brain metastases or other central nervous system metastases.
• Patients receiving concomitant immunosuppressive agents or chronic corticosteroid use at the time of study entry except in cases outlined below:
• Topical applications (e.g. rash) Inhaled sprays (e.g. obstructive airways disease)
• Eye drops
• Local injections (e.g. intra-articular)
• Stable low dose of corticosteroids for at least two weeks before enrolment
• Patients with known HIV seropositivity. Screening for HIV infection at baseline is not required

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (3)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

VITAZ

Sint-Niklaas, East-Flanders, 9100, Belgium

RECRUITING

Bank of Cyprus Oncology Center

Nicosia, 2006, Cyprus

TERMINATED

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Central Study Contacts

Timon Vandamme

CONTACT

038212111; timon.vandamme@uza.be

Marc Peeters

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: March 7, 2022
• Study Start: May 27, 2019
• Primary Completion: May 27, 2025
• Study Completion: December 31, 2025
• Last Updated: March 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); CY (1)