Clinical trial • Not applicable • Oncology|Respiratory
NELARABINE for Lung cancer
Not applicable trial of NELARABINE for Lung cancer. open-label. 7 participants.
Overview
- Trial Therapeutic Area
- Oncology|Respiratory
- Trial Disease
- Lung cancer
- Trial Stage
- Not applicable
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 24-09-2025
- First CTIS Authorization Date
- 27-01-2026
Trial design
open-label Not applicable trial across 1 site in Netherlands.
- Open Label
- Yes
- Target Sample Size
- 7
Eligibility
Recruits 7 No vulnerable populations selected; all participants must be above 18 and provide written informed consent. No assent procedures or other vulnerable-population consent arrangements are described..
- Pregnancy Exclusion
- Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.
- Vulnerable Population
- No vulnerable populations selected; all participants must be above 18 and provide written informed consent. No assent procedures or other vulnerable-population consent arrangements are described.
Inclusion criteria
- {"criterion_text":"- 1. Histologically confirmed lung cancer"}
- {"criterion_text":"- 2. At least 1 lesion with size of ≥2cm"}
- {"criterion_text":"- 3. Willing and able to provide written informed consent for the trial"}
- {"criterion_text":"- 4. Above 18 years of age on day of signing informed consent"}
- {"criterion_text":"- 5. Have measurable disease based on RECIST 1.1"}
Exclusion criteria
- {"criterion_text":"- 1. Patients on active immunomodulatory treatment"}
- {"criterion_text":"- 2. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease."}
- {"criterion_text":"- 3. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial."}
- {"criterion_text":"- 4. Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The absolute and relative difference in SUV and TBR uptake between both scanning timepoints","definition_or_measurement_approach":"Measured as the absolute and relative difference in standardized uptake value (SUV) and target-to-background ratio (TBR) uptake between two closely obtained [18F]F-AraG PET scan timepoints (test-retest variability assessment)."}
Recruitment
- Planned Sample Size
- 7
- Recruitment Window Months
- 9
- Consent Approach
- Participants must be willing and able to provide written informed consent; participants must be above 18 years of age at signing. A subject information and informed consent form document is listed; no details on assent, multi-language documents, or remote consent procedures are provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 7
Netherlands
- Earliest CTIS Part Ii Submission Date
- 15-12-2025
- Latest Decision Or Authorization Date
- 27-01-2026
- Processing Time Days
- 43
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- Idris Bahce
- Principal Investigator Email
- ctis@amsterdamumc.nl
- Contact Person Name
- Idris Bahce
- Contact Person Email
- ctis@amsterdamumc.nl
- Number Of Participants
- 7
Sponsor
Primary sponsor
- Full Name
- Amsterdam UMC Stichting
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- NELARABINE
- Active Substance
- NELARABINE
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- Intravenous
- Authorisation Status
- Modified into radiopharmaceutical tracer; marketingAuthNumber: -; prodAuthStatus: 2
- Maximum Dose
- 204 MBq
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