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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07274384
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
- A person (or their legal representative) has given written consent to take part in the study and to the use of their personal data.
- People aged 18 years or older, of any sex.
- People whose general physical functioning falls within a certain range, meaning they are able to care for themselves and may or may not be able to do light work (confirm with trial site — this refers to an ECOG Performance Status of 0–2).
- People who have been confirmed by tissue or cell testing to have stage IV non-small cell lung cancer (a specific advanced stage of lung cancer) and have not yet received any systemic treatment for cancer that has spread or returned.
- Tumours that are a mix of different cell types may also be eligible.
- People whose tumour tests show a PD-L1 score of 50% or higher (measured by a local laboratory test).
- People whose cancer does not have certain specific genetic changes (in EGFR, ALK, or ROS1) that would point to a different targeted treatment.
- People whose blood test at screening shows a specific type of immune cell (called CD10- LDNs) making up more than 30.5% of a certain group of blood cells — this will be measured and confirmed centrally by the study coordinating centre.
- People who have measurable disease visible on two CT scans done before joining the trial, meeting all of the following conditions:
- At least one measurable area of cancer that has not previously been treated with radiotherapy.
- Scans of the chest and abdomen must be included.
- The scans must be available to be sent (anonymised) to a central radiologist for independent confirmation.
- The two pre-treatment CT scans must be taken no less than 2 weeks apart and no more than 12 weeks apart.
- The most recent scan must be taken no more than 4 weeks before treatment begins.
- People who are willing to provide blood samples at set points during the study for research purposes.
- People whose blood and organ function results fall within acceptable ranges, including:
- Sufficient levels of a type of white blood cell (neutrophils).
- Sufficient platelet count (cells that help blood clot).
- Sufficient haemoglobin (the protein in red blood cells that carries oxygen).
- Adequate kidney function — the required level depends on which chemotherapy drug is used (confirm with trial site).
- Bilirubin (a substance processed by the liver) within an acceptable range, with an exception possible for people with a confirmed condition called Gilbert's syndrome (confirm with trial site).
- Liver enzyme levels (AST and ALT) within an acceptable range.
- People who do not have a known severe allergic reaction (grade 3 or higher) to any of the study chemotherapy drugs, the immunotherapy drug cemiplimab, or any of their ingredients.
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 who had an infection serious enough to require hospitalisation or intravenous (IV) antibiotics or antifungals within 2 weeks before the first dose of study treatment.
- People with a known uncontrolled infection with HIV, hepatitis B, hepatitis C, tuberculosis (active or latent), or a known condition that weakens the immune system.
- People who received a live or live-attenuated vaccine (a type of vaccine made with a weakened form of a virus or bacteria) within 30 days before the baseline blood test for the study; or who received a COVID-19 vaccine within 1 week before the planned start of study treatment, or whose COVID-19 vaccination course would not be completed at least 1 week before treatment starts.
- People with a history of a specific type of lung inflammation called interstitial lung disease (such as idiopathic pulmonary fibrosis or organising pneumonia), or who have had active non-infectious lung inflammation that needed high-dose immune-suppressing steroid treatment.
- People who received radiotherapy within 7 days before the baseline blood test for the study.
- People who received certain medications that stimulate blood cell production (such as G-CSF, GM-CSF, or erythropoietin) within 28 days before the baseline blood test; preventive use of these medications during the study is also not permitted, and any necessary use must be discussed with the coordinating centre.
- People with ongoing or recent significant autoimmune disease that required treatment with systemic immune-suppressing medications — however, certain conditions are not disqualifying, including vitiligo, childhood asthma that has fully resolved, hormone-related conditions such as an underactive thyroid or type 1 diabetes managed only with hormone replacement, or psoriasis that does not need systemic treatment.
- People who are pregnant or breastfeeding, or people of reproductive potential who are not using a highly effective form of contraception.
- People with any other condition that, in the treating doctor's opinion, would interfere with assessing the study treatment or interpreting the results.
- People currently receiving any other chemotherapy, immunotherapy, biological therapy, or hormonal therapy for cancer (hormonal therapy for non-cancer reasons, such as hormone replacement therapy, is acceptable).
- People who have received a transplant of donated tissue or a solid organ from another person.
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Università Vita-Salute San Raffaele
Registry
ClinicalTrials.gov
Start date
1 January 2026
Est. completion
31 December 2029
Primary endpoints
HPD rate; ED rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.