Early Phase 1 Lung Cancer Trial, By Invitation
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are willing to give informed consent and agree to follow the requirements set out in the trial protocol.
- People aged 18 to 75 years old at the time of signing the consent form.
- People who have a confirmed diagnosis (through cell or tissue testing) of locally advanced, inoperable, or metastatic small cell lung cancer.
- People who have at least one area of disease that can be measured using standard imaging criteria (called RECIST 1.1).
- People who have a general health and activity level rated at 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity.
- People who have a life expectancy of at least 3 months.
- Women who could become pregnant must use a highly effective form of contraception from the screening visit until at least 12 months after the last dose of the trial treatment (iNK cells).
- Men must either be sterile (naturally or through surgery) or use a highly effective form of contraception from the screening visit until at least 12 months after the last dose of the trial treatment (iNK cells).
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People whose organs are not functioning well enough, including those with serious heart conditions such as a dangerously abnormal heart rhythm (QTc interval of 480 ms or more).
- People with certain types of electrical conduction problems in the heart, such as complete left bundle branch block, or second- or third-degree heart block.
- People with severe, uncontrolled irregular heart rhythms that require medication to manage.
- People with moderate to severe heart failure (rated as New York Heart Association Class II or above).
- People whose heart pumping function (left ventricular ejection fraction) is below 50% as measured by heart ultrasound.
- People who have had a heart attack, unstable chest pain, severe irregular heart rhythm, serious disease around the heart, or signs of reduced blood flow to the heart within the 6 months before joining the trial.
- People with kidney function below a certain level, based on blood test results or a calculated kidney function score (confirm with trial site for specific thresholds).
- People with certain liver function abnormalities, including elevated bilirubin or liver enzyme levels above set thresholds (confirm with trial site for specific values).
- People with breathing difficulties rated above grade 1, or blood oxygen levels at or below 91% when not using supplemental oxygen.
- People with low blood cell counts, including low white blood cells, low platelets, low haemoglobin, or abnormal blood clotting results (confirm with trial site for specific thresholds).
- People who have central nervous system (CNS) metastases that are currently causing symptoms (those with no symptoms, or whose symptoms have been treated and have been stable for at least 4 weeks, may still be considered).
- People who have a history of certain brain or neurological conditions before screening, such as epilepsy, stroke, paralysis, dementia, Parkinson's disease, or certain autoimmune conditions affecting the brain or nervous system.
- People who stopped systemic hormone therapy less than 72 hours before the cell treatment (low-dose replacement hormones, such as prednisone under 10 mg per day or an equivalent, may be permitted — confirm with trial site).
- People with a known active autoimmune disease that is currently being treated.
- People who test positive for hepatitis B surface antigen and/or hepatitis B e antigen.
- People who test positive for certain hepatitis B antibodies and also have a detectable level of hepatitis B virus (HBV-DNA) in their blood.
- People who test positive for hepatitis C antibodies.
- People who test positive for syphilis antibodies.
- People who test positive for HIV antibodies.
- People with detectable levels of Epstein-Barr virus (EBV) or cytomegalovirus (CMV) DNA in their blood above the measurable limit.
- People who have taken part in another interventional clinical trial within 4 weeks before screening.
- People who are allergic to human blood albumin.
- People who are allergic to IL-2 (a substance used in the trial treatment process).
- People whom the trial investigator considers unsuitable for participating in this study for any reason.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
Primary endpoints
Number of Participants with Adverse Event (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0; Objective-response rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.