Printed from Voxsanity (voxsanity.com.au) — NCT07538193 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Lung Cancer Trial, Not Yet Recruiting
NCT07538193
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 take part voluntarily and sign a consent form.
- People aged 18 or older, of any gender.
- People who have been confirmed by tissue or cell testing to have a specific stage of non-small cell lung cancer (NSCLC) called TanyN2b (based on AJCC 9th edition staging), with lymph node involvement verified through specific procedures such as EBUS/EUS or mediastinoscopy (confirm with trial site for details on lymph node station requirements).
- People whose lung cancer has been assessed by a specialist team — including a cancer-trained chest surgeon — as being fully removable by surgery (with no cancer left behind).
- People who have at least one measurable area of cancer that can be tracked using standard imaging guidelines (RECIST v1.1).
- People who are generally well enough to carry out daily activities, with a performance score of 0 or 1 on a standard medical scale (meaning fully active or restricted in strenuous activity only).
- People whose blood and organ function test results meet all of the following requirements, without having received blood products or growth factor treatments in the 14 days before starting the trial: a white blood cell count (neutrophils) of at least 1.5×10⁹/L; a platelet count of at least 100×10⁹/L; a haemoglobin level of at least 90 g/L; kidney function within an acceptable range (creatinine no more than 1.5 times the normal upper limit, or a calculated kidney clearance rate of at least 40 mL/min); liver bilirubin levels no more than 1.5 times the normal upper limit (up to 3 times for people with a condition called Gilbert's syndrome); liver enzyme levels (AST and ALT) no more than 3 times the normal upper limit; blood clotting measures (INR or APTT) within 1.5 times the normal upper limit, unless already on blood-thinning medication; and a heart pumping function (left ventricular ejection fraction) of at least 50%.
- Women who could become pregnant must agree to use an accepted form of contraception (such as an IUD, contraceptive pill, or condoms) during treatment and for 3 months after treatment ends, must have a negative pregnancy test within 72 hours before starting the trial, and must not be breastfeeding.
- Men whose partners could become pregnant must agree to use effective contraception during the trial and for 3 months after the last dose of the study drugs (Iparomlimab/Tuvonralimab).
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 lung cancer has a known EGFR or ALK gene mutation.
- People who have had another cancer in the past 5 years, with some exceptions such as certain fully treated skin cancers, cervical cancer in situ, localised prostate cancer after surgery, or ductal breast cancer in situ after surgery.
- People who have already received any treatment for their current lung cancer, such as radiotherapy, chemotherapy, targeted therapy, or ablation.
- People who are currently taking immune-suppressing medications or steroid tablets at a dose higher than 10 mg per day of prednisone (or equivalent), and have continued these within 2 weeks before enrolling (inhaled or topical steroids and low-dose replacement steroids are generally permitted if there is no active autoimmune disease).
- People who have an active autoimmune disease or a history of one, including conditions such as autoimmune hepatitis, lung inflammation or scarring, uveitis, bowel inflammation, liver inflammation, pituitary inflammation, blood vessel inflammation, kidney inflammation, or thyroid disorders — though people whose hypothyroidism is managed with hormone replacement therapy alone, or people with certain skin conditions (such as vitiligo, psoriasis, or alopecia) or type 1 diabetes not requiring systemic treatment, or adults with childhood asthma that has fully resolved and requires no current treatment, may still be considered eligible; people with asthma that requires steroid treatment are not eligible.
- People who have had a bone marrow or organ transplant in the past (except corneal transplants).
- People with a congenital or acquired immune deficiency, such as HIV infection.
- People with uncontrolled active hepatitis B, as defined by specific blood test results at screening (some people with hepatitis B who have been on standard antiviral treatment for at least 4 weeks and have low virus levels may still be considered — confirm with trial site); or people with active hepatitis C confirmed by blood testing.
- People who have had a severe allergic reaction to another monoclonal antibody medication in the past.
- People who have received a live vaccine within 30 days before starting the trial (this restriction continues until 90 days after the last dose); live vaccines include measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and typhoid — inactivated flu and COVID-19 vaccines are generally permitted.
- People who have had significant heart or brain blood vessel problems, including: a heart attack or unstable chest pain within the past 6 months; a stroke or mini-stroke within the past 6 months; high blood pressure not controlled by medication (systolic at or above 160 mmHg and/or diastolic at or above 100 mmHg); serious heart rhythm problems that have not been stable for at least 14 days before starting the trial; heart failure classified as severe (NYHA class III or IV); or heart muscle inflammation (myocarditis).
- People who have had a serious infection requiring intravenous antibiotics for more than 7 days within the 2 weeks before starting treatment, or who have an unexplained fever above 38.5°C at the time of screening or before enrolling (fevers thought to be caused by the tumour itself may be excluded — confirm with trial site).
- People who have any other condition that, in the treating doctor's judgement, could affect the trial results or raise safety concerns, such as alcohol or drug dependence, serious mental illness, other serious medical conditions requiring treatment, or significant personal or social circumstances.
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.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
Contact this trial
Phone: +8615991269383
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
Not Applicable
Sponsor
Tang-Du Hospital
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
1 May 2029
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Pathological Complete Response (pCR) rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 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.