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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07031154
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 aged between 18 and 70 years old, of any gender.
- People with a good general health and activity level, able to carry out normal daily activities with little or no limitation (confirmed by a doctor using a standard performance scale called ECOG PS score 0–1).
- People who have not received any prior treatment for their cancer and who agree to have surgery with the aim of fully removing the tumour, and whose surgeon has assessed them as having no reason surgery cannot be performed.
- People diagnosed with a specific type of lung cancer — stage II, IIIA, or a selected group of stage IIIB (T3N2M0 only) — that is either squamous cell or non-squamous non-small cell lung cancer, confirmed by tissue or cell testing, and assessed by the trial doctor as suitable for complete surgical removal (confirm with trial site for staging details).
- People whose cancer has not grown into the heart, major blood vessels, windpipe, certain nerves, food pipe, spine, or spread as separate tumour nodules in different sections of the same lung — and who do not have a type of tumour in the upper part of the chest called superior sulcus (Pancoast) tumour.
- People whose cancer has spread to nearby chest lymph nodes (called N2 disease), where those lymph nodes are smaller than 2 cm and are expected to be fully removable by surgery.
- People whose tumour tissue sample is available for testing, and whose tumour shows a protein called PD-L1 at a level of 1% or more.
- People who have at least one tumour that can be measured using standard imaging guidelines (RECIST 1.1).
- People expected to live for at least 12 weeks.
- People whose major organs are functioning well, including meeting specific blood count requirements — such as haemoglobin of 90 g/L or above (without recent blood transfusions or boosting medications in the past 2 weeks), neutrophil count of 1.5×10⁹/L or above, and platelet count of 100×10⁹/L or above.
- People whose liver function test results are within acceptable ranges — total bilirubin no more than 1.5 times the upper limit of normal, and liver enzymes (ALT, AST, alkaline phosphatase) no more than 2.5 times the upper limit of normal.
- People whose kidney function is within acceptable ranges — blood creatinine no more than 1.5 times the upper limit of normal, and kidney clearance rate of at least 60 ml/min.
- People whose blood clotting results are within acceptable ranges (INR no more than 1.5 times normal, and APTT no more than 1.5 times the upper limit of normal), for those not receiving blood-thinning medication.
- People whose cancer has not spread to distant parts of the body.
- People whose cancer is expected to be fully and completely removable by surgery.
- People with lung function good enough to tolerate surgical treatment.
- Women who could become pregnant must have a negative pregnancy test within 3 days before starting the study drug, and must agree to use highly effective contraception during the study and for 90 days after the last dose; men whose partners could become pregnant must agree to use effective contraception or confirm surgical sterilisation, during the study and for 90 days after the last dose.
- People who voluntarily agree to take part and sign a consent form.
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 have previously received any cancer treatment, including radiotherapy, chemotherapy, immunotherapy, or traditional Chinese medicine-based cancer treatment — unless the prior cancer was treated with curative intent, fully resolved, and has not returned or spread for more than 5 years.
- People with non-squamous cell type lung cancer who test positive for EGFR mutation or ALK gene changes (all people with non-squamous cell type must be tested for these genetic markers before joining).
- People whose cancer has already spread to distant parts of the body (including M1a, M1b, or M1c).
- People with an active autoimmune disease, or a history of autoimmune conditions such as eye inflammation, bowel inflammation, liver inflammation, gland problems, blood vessel inflammation, heart muscle inflammation, kidney inflammation, or thyroid disorders — though some exceptions may apply (confirm with trial site).
- People with evidence of lung scarring, interstitial lung disease, dust-related lung disease, radiation-related lung damage, drug-related lung damage, active lung infection shown on imaging, or severely reduced lung function.
- People who have taken corticosteroid tablets or other immune-suppressing medicines at higher than a low threshold dose (more than 10 mg/day of prednisone or equivalent) within 2 weeks before the first study dose — though inhaled or skin-applied steroids and low-dose hormone replacement are permitted.
- People whose scans (CT or MRI) show the tumour has grown into or has unclear boundaries with large blood vessels, or where scans show any hollow cavities or areas of tissue breakdown within the tumour, as assessed by the investigator.
- People who have had a blood clot or stroke-related event — including mini-stroke, brain bleed, brain infarction, deep vein blood clot, or lung blood clot — within the 6 months before joining.
- People who have had significant bleeding, a bleeding stomach ulcer, or who have been receiving blood-thinning or clot-dissolving treatment within 3 months before joining.
- People who have been coughing up notable amounts of blood (2.5 mL or more per day) within the month before joining.
- People with poorly controlled high blood pressure (systolic at or above 140 mmHg or diastolic at or above 90 mmHg despite medication), or significant heart problems such as reduced heart pumping function, heart rhythm problems (including a prolonged QTc interval), or heart insufficiency rated at grade III or IV by standard heart failure criteria.
- People who have had a major operation or serious injury to another part of the body within 2 months before the study starts.
- People whose urine test shows a significant level of protein in the urine, or who have severe kidney or liver failure.
- People with fluid build-up around the lungs, heart, or in the abdomen that cannot be controlled and requires repeated draining.
- People who are known to be allergic to the study drug.
- People living with HIV infection or active viral hepatitis.
- Women who are pregnant or breastfeeding, or people of reproductive capacity who are unwilling or unable to use effective contraception.
- People with neurological or psychiatric conditions that would prevent them from cooperating with the study.
- People diagnosed with another type of cancer within the past 5 years — with some exceptions, including certain fully treated skin cancers, early cervical cancer, localised prostate cancer after full surgical treatment, and certain breast duct cancers after full surgical treatment.
- People considered unsuitable for other reasons as determined by the trial investigator.
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.
Contact this trial
Phone: 13950073075
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
The First Affiliated Hospital of Xiamen University
Registry
ClinicalTrials.gov
Start date
30 June 2025
Est. completion
1 February 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Major pathological response (MPR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 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.