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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07035392
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
- Adults aged 18 to 70 years old, of any gender.
- People with a good general health and activity level, rated 0 or 1 on a standard medical scale called ECOG (meaning fully active or able to carry out light activity).
- People who have not previously received any systemic cancer treatment and who agree to undergo surgery aimed at fully removing the cancer, and who have been assessed by a chest surgeon as having no reasons that would prevent surgery.
- People diagnosed with stage II, IIIA, or a specific type of stage IIIB (T3N2M0 only) non-small cell lung cancer (either squamous or non-squamous type), confirmed by a tissue or cell sample, and assessed by the research team as suitable for surgery with the goal of completely removing the cancer.
- People whose tumour tissue shows a protein called PD-L1 at a level of 1% or higher, with enough tumour tissue available for testing.
- People who have at least one measurable area of cancer, assessed using standard medical measurement guidelines (RECIST 1.1).
- People with an expected survival of at least 12 weeks.
- People whose blood counts meet the required levels: haemoglobin at least 90g/L (without recent blood transfusion or blood-boosting medications in the 2 weeks before starting the trial), neutrophil count at least 1.5 × 10⁹/L, and platelet count at least 100 × 10⁹/L.
- People whose liver function blood test results fall within acceptable ranges: total bilirubin no more than 1.5 times the upper limit of normal, and liver enzymes (ALT, AST, and alkaline phosphatase) no more than 2.5 times the upper limit of normal.
- People whose kidney function is within acceptable ranges: serum creatinine no more than 1.5 times the upper limit of normal, and a kidney clearance rate of at least 60ml/min.
- People not on blood-thinning (anticoagulant) therapy whose blood clotting test results (INR and APTT) are within acceptable ranges.
- People assessed as likely to have the cancer completely removed during surgery.
- People with lung function good enough to tolerate surgical treatment.
- Women who are able to become pregnant must have a negative pregnancy test (blood or urine) within 72 hours before starting the study medication, and must agree to use an effective form of contraception (such as an intrauterine device, contraceptive pill, or condom) during the study and for 90 days after the last dose; male participants whose partners could become pregnant must also agree to use effective contraception or have had a surgical sterilisation procedure, during the study and for 90 days after the last dose.
- People who voluntarily agree to take part and have signed an informed 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 herbal anti-cancer treatment (excluding treatment for a separate cancer that was fully cured with no recurrence or spread for 5 or more years).
- People with non-squamous cell NSCLC who test positive for EGFR gene mutations or ALK gene changes (all non-squamous cell participants must be tested for these gene changes).
- People whose cancer has spread to distant parts of the body (distant metastases).
- People who currently have, or have a history of, an active autoimmune disease (such as certain eye, bowel, liver, hormone, heart, kidney, or thyroid conditions, or tuberculosis); people with childhood asthma that has fully resolved and requires no ongoing treatment in adulthood, or certain skin conditions (such as vitiligo, psoriasis, or hair loss) that need no systemic treatment, may still be considered, but people with asthma requiring bronchodilator medication cannot be included.
- People with evidence of lung scarring conditions such as pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation-related lung damage, drug-related lung damage, or currently active pneumonia confirmed on imaging, or severely reduced lung function.
- People who have taken corticosteroid medications at doses above 10mg/day of prednisone (or an equivalent dose of another steroid), or other immune-suppressing medications, within the 2 weeks before starting the trial (use of inhaled or topical steroids, or low-dose hormone replacement of 10mg/day or less, may be permitted in people without active autoimmune disease).
- People whose scans (CT or MRI) show the tumour growing into major blood vessels or having unclear boundaries with blood vessels, or show any lung cavities or areas of tissue breakdown within the tumour, as assessed by the research team.
- People who have had a blood clot or stroke event in the 6 months before enrolling, such as a mini-stroke (TIA), brain bleed, brain infarction, deep vein thrombosis, or pulmonary embolism.
- People who have had a significant bleeding episode in the 3 months before enrolling (such as gastrointestinal bleeding or bleeding stomach ulcer), or who are currently receiving clot-dissolving or blood-thinning therapy.
- People who have been coughing up 100mL or more of blood per day before enrolling, or who are assessed by the research team as being at high risk of coughing up blood.
- People with high blood pressure that cannot be adequately controlled with medication (systolic blood pressure 140 mmHg or above, or diastolic blood pressure 90 mmHg or above); people with moderate or severe coronary artery disease or heart attack history; people with poorly controlled heart rhythm problems (including a heart electrical interval called QTc that is 450ms or more in males or 470ms or more in females); or people with grade III–IV heart failure according to standard criteria, or a heart pumping function (LVEF) below 50% on echocardiogram.
- People who have had major surgery or a serious injury within the 2 months before starting the trial.
- People whose urine test shows a significant level of protein (2+ or above), or whose 24-hour urine protein is 1g or more, or who have severe liver or kidney problems.
- People with fluid build-up around the lungs, heart, or abdomen that cannot be controlled and requires repeated draining.
- People who are known to be allergic to the trial medication.
- People with HIV infection or active viral hepatitis.
- Women who are pregnant or breastfeeding, or people who are able to have children but are unwilling or unable to use effective contraception.
- People with neurological or mental health conditions that would prevent them from cooperating with the trial.
- People who have had another cancer within the 5 years before enrolling (certain fully treated cancers such as cervical carcinoma in situ, some skin cancers, localised prostate cancer after radical surgery, or ductal breast carcinoma in situ after radical surgery may be excluded from this restriction — confirm with trial site).
- People who the research team considers unsuitable for any other 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.
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: 13960025158
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Zhangzhou Municipal Hospital
Registry
ClinicalTrials.gov
Start date
20 June 2025
Est. completion
1 December 2026
Primary endpoints
Main pathological relief (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.