Phase 2 Lung Cancer Trial, Not Yet Recruiting
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 and able to give informed consent to take part in the trial
- People aged 18 years or older, of any gender
- People with a performance status rating of ECOG 0–1, meaning they are fully active or have only minor limitations in physically strenuous activity (confirm with trial site)
- People diagnosed with early-stage, operable non-small cell lung cancer (NSCLC), specifically stage II to IIIA, of squamous or non-squamous type, who have not yet received treatment, and whose tumour tests positive for PD-L1 at 50% or higher — this includes people who are eligible for standard treatment as well as those who cannot have chemotherapy, provided other criteria are met
- People whose PD-L1 result of 50% or higher has been confirmed using a specific laboratory test called the DAKO 22C3 assay
- People whose blood counts are at acceptable levels, including: white blood cell count (ANC) of at least 1.5 x 10⁹/L, haemoglobin of at least 9.0 g/dL, and platelet count of at least 75,000/mm³
- People whose liver function is within acceptable ranges, including liver enzyme levels (AST and ALT) no more than 3 times the upper limit of normal, and bilirubin no more than 1.5 times the upper limit of normal (or up to 3 times the upper limit of normal for people with a documented condition called Gilbert's Syndrome)
- People whose kidney function is within acceptable ranges, either by creatinine level no more than 1.5 times the upper limit of normal, or by a calculated kidney clearance rate of at least 50 ml/min
- Women who could become pregnant, and men whose partner could become pregnant, who are willing to use highly effective contraception during the trial and for 4 months after it ends
- People whose routine blood test results and heart trace (ECG) results are acceptable during the screening period
- People who, in the investigator's opinion, are able and willing to follow all trial requirements
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 cancer has spread to distant parts of the body (metastases) found during screening
- People whose tumour has specific gene changes, including EGFR mutations or ALK, RET, or ROS1 gene translocations
- People who need ongoing daily corticosteroid medication above 10 mg of prednisone (or equivalent anti-inflammatory dose) within one week before the first study dose — although people who need a short course of up to 2 days of steroids in that week, or who need steroids for hormone replacement, are not excluded
- People with significant kidney or liver impairment
- People with certain heart or blood vessel conditions, including: heart failure classified as New York Heart Association Class II, III, or IV; a heart attack or acute coronary syndrome within the past 12 months; or a mini-stroke (transient ischaemic attack) or stroke within the past year
- People who have planned surgery or any procedure requiring general anaesthesia during the trial
- People whose life expectancy is less than 6 months, or for whom placebo medication would be inappropriate
- People with any other significant illness or condition that, in the investigator's opinion, could put them at risk from taking part, could affect the trial results, or could affect their ability to participate
- People with ongoing or recent significant autoimmune disease that required systemic immunosuppressive treatment within the past 2 years — note that the following conditions are not considered exclusionary: vitiligo, childhood asthma that has resolved, hormone-replacement-only conditions such as hypothyroidism or type 1 diabetes, or psoriasis not requiring systemic treatment
- People who have had an infection requiring hospitalisation or intravenous (IV) antibiotic or antiviral treatment within 2 weeks before the first study dose
- People with uncontrolled HIV, hepatitis B, hepatitis C, any diagnosis of immune deficiency, or active or latent tuberculosis — noting that people with well-controlled HIV (undetectable viral load and CD4 count above 350), well-controlled hepatitis B (undetectable HBV DNA on antiviral therapy), certain hepatitis B antibody-positive cases meeting specific monitoring requirements, or resolved hepatitis C infection may be eligible (confirm with trial site)
- People who have received a live vaccine within 4 weeks before starting study medication
- People who have received a COVID-19 vaccine within 1 week before the planned start of study medication, or whose planned COVID-19 vaccinations would not be completed at least 1 week before starting study medication
- People with a known allergy or sensitivity to the active ingredients or any other components of the study medication
- Women of childbearing potential and men who are unwilling to use highly effective contraception before, during, and for at least 6 months after the last study dose — acceptable methods include combined or progestogen-only hormonal contraception (started at least 2 menstrual cycles before screening), an intrauterine device or hormone-releasing intrauterine system, bilateral tubal occlusion or ligation, a vasectomised sole sexual partner (with confirmed surgical success), or complete sexual abstinence — noting that periodic abstinence, withdrawal, spermicides alone, or lactational amenorrhoea are not considered acceptable, and female and male condoms should not be used together
- Male participants who do not agree to use condoms or practise complete sexual abstinence (unless vasectomised, with confirmed success) before, during, and for at least 6 months after the last study dose, and who do not agree to avoid sperm donation during that period
- People who have taken part in another clinical trial involving an experimental treatment within the past 12 weeks
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.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
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Trial details
Where this trial is recruiting
Primary endpoints
Pathologic Complete Response Rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.