Overview
Sponsor-declared trial summary
Patients with non-small cell lung cancer
To correlate the uptake of 68GaNOTA-AntiMMR-VHH2 in a NSCLC lesion before surgery with the immunohistological MMR-staining of the excised lesion.
Key facts
- Sponsor
- UZ Brussel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Feb 2023 → ongoing
- Decision date (initial)
- 2024-10-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514138-19-00
- EudraCT number
- 2021-005575-40
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Efficacy
To correlate the uptake of 68GaNOTA-AntiMMR-VHH2 in a NSCLC lesion before surgery with the immunohistological MMR-staining of the excised lesion.
Conditions and MedDRA coding
Patients with non-small cell lung cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patients who have given informed consent
- Patients at least 18 years old
- Patient with local, locally advanced or metastatic disease of lung cancer, who is planned for resection or surgical biopsy of at least one lesion. In order to minimise partial volume effect, the diameter of the tumour to be resected or biopsied should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions
- Patients who participated already in this study can be included if the subject meets all of the inclusion and none of the exclusion criteria at time of second inclusion.
Exclusion criteria 8
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
- Pregnant patients
- Breast feeding patients
- Patients with any serious active infection
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
- Patients who are unlikely to cooperate with the requirements of the study
- Patients who are unwilling and/or unable to give informed consent
- Patients at increased risk of death from a pre-existing concurrent illness
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Immunohistological MMR score on excised tissue
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11008416 · Product
- Active substance
- Nanobody Against Macrophage Mannose Receptor, Conjugated with 147-TRIAZACYCLONONANE-NNN-TRIACETIC Acid, Labelled with Gallium GA-68
- Substance synonyms
- 68GaNOTA-anti-MMR-VHH2
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 370 MBq megabecquerel(s)
- Max total dose
- 370 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- UZ BRUSSEL
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Brussel
- Sponsor organisation
- UZ Brussel
- Address
- Laarbeeklaan 101
- City
- Jette
- Postcode
- 1090
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Brussel
- Contact name
- Prof. Dr. Tony Lahoutte
Public contact point
- Organisation
- UZ Brussel
- Contact name
- Prof. Dr. Tony Lahoutte
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-02-15 | 2023-06-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol_CLEAN_REDACTED | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material | 1.0 |
| Subject information and informed consent form (for publication) | SIS and ICF adults_ENG_redacted | 3.0 |
| Subject information and informed consent form (for publication) | SIS and ICF adults_FR_redacted | 3.0 |
| Subject information and informed consent form (for publication) | SIS and ICF adults_NL_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-514138-19-00_ENG | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-514138-19-00_FR | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-514138-19-00_GE | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-514138-19-00_NL | 1.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Belgium | Acceptable 2024-10-25
|
2024-10-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-07 | Belgium | Acceptable 2025-04-18
|
2025-04-18 |