Printed from Voxsanity (voxsanity.com.au) — NCT06704620 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Lung Cancer
Phase 3 Lung Cancer Trial, Not Yet Recruiting
NCT06704620
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 sign a written consent form before any trial procedures begin.
- People aged 18 to 75 years old.
- People with a good general health status, able to carry out normal activity with little or no restriction (this is measured using a standard scale called ECOG, with a score of 0 or 1).
- People whose doctors expect them to live for more than 3 months.
- People diagnosed with advanced non-small cell lung cancer (stage IIIB to IV), or early-stage lung cancer that has come back after surgery, where the cancer is of a specific type (adenocarcinoma or adenosquamous carcinoma) and does not have certain genetic changes (EGFR must be normal/"wild type" and ALK fusion gene must be negative); for stage IIIB/C, the cancer must not be treatable with surgery or radiotherapy aimed at a cure (confirm with trial site).
- People who have not previously received any systemic treatment for their cancer.
- People whose treatment plan includes a specific immunotherapy drug (Tislelizumab) combined with standard platinum-based chemotherapy — squamous lung cancer patients would use albumin-bound paclitaxel plus platinum, and non-squamous patients would use pemetrexed plus platinum.
- People who have at least one area of cancer that can be clearly measured on a scan, following standard measurement guidelines (RECIST version 1.1).
- People who have received palliative radiation therapy (including radiation to the brain for brain metastases causing symptoms), provided any side effects from that radiation have recovered to a mild level or better (grade 1 or less, except for hair loss).
- People whose blood test results show the body's organs are working well enough, specifically: neutrophil count at least 1.5×10⁹/L without recent use of growth factor support; platelet count at least 100×10⁹/L without recent blood transfusion; haemoglobin above 9g/dL without recent transfusion or supportive medication; bilirubin within 1.5 times the normal upper limit; liver enzymes (AST and ALT) within 2.5 times the normal upper limit (or up to 5 times if liver metastases are present); kidney function within acceptable limits; blood clotting within 1.5 times the normal upper limit; thyroid hormone levels within the normal range (or with acceptable T3/T4 levels if TSH is slightly outside range); and heart muscle enzyme levels within the normal range.
- Women of childbearing age must have a negative pregnancy test (urine or blood) within 3 days before the first dose.
- All people with a risk of pregnancy (male or female) must use a highly effective form of contraception (with a failure rate of less than 1% per year) throughout the treatment period and for up to 120 days (or 180 days after the last dose) after treatment ends.
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 spread from a primary cancer located somewhere else in the body (i.e., the lung cancer is a secondary/metastatic cancer, not the original cancer).
- People who have had, or currently have, another type of cancer, with the exception of certain skin cancers or non-invasive cancers that have been fully treated and removed.
- People who have previously received immunotherapy as part of treatment around the time of surgery (either before or after the operation).
- People whose cancer has known driver gene mutations such as EGFR, ALK, or ROS1.
- People who have been diagnosed with myasthenia gravis (a muscle weakness condition) at any point, or who currently have it.
- People who have been diagnosed with angle-closure glaucoma (a type of eye pressure condition) at any point, or who currently have it.
- People who have been diagnosed with an enlarged prostate at any point, or who currently have it.
- People who are allergic to the antihistamine medication diphenhydramine or any of its ingredients.
- People who have blockages or narrowing in the stomach outlet or upper small intestine due to peptic ulcers, or narrowing at the outlet of the bladder.
- People who have had radiation therapy before the trial that meets certain conditions: radiation to 30% or more of the bone marrow within the 14 days before treatment, or radiation to lung areas within 6 weeks before treatment at a dose greater than 30Gy — and in either case, the side effects must have fully resolved to a mild level or below, with no need for steroid treatment and no history of radiation-related lung inflammation.
- People who are currently taking part in another interventional clinical trial, or who have received another experimental drug or device within 4 weeks before the first dose.
- People who have received traditional Chinese medicines with anti-cancer or immune-modifying effects (such as thymosin, interferon, or interleukin) as a systemic treatment, except when used locally to manage fluid in the chest cavity.
- People who have had an active autoimmune disease within the past 2 years that required systemic medical treatment (such as immune-suppressing drugs or steroids); hormone replacement therapies used to manage gland-related conditions are not considered systemic treatment for this purpose.
- People who have been taking systemic steroid medication (not including nasal sprays, inhalers, or other topical uses) within 7 days before the first dose, or any other immune-suppressing therapy — except for low physiological doses of steroids (equivalent to 10mg or less of prednisone per day).
- People who have uncontrolled fluid build-up around the lungs or in the abdomen that requires ongoing drainage (confirm with trial site for exceptions).
- People who have received an organ transplant from another person (other than a cornea transplant), or a bone marrow/stem cell transplant from another person.
- People who have not yet fully recovered from side effects or complications of any previous treatment (side effects must be at grade 1 or at their personal baseline, except for fatigue or hair loss).
- People with a known history of HIV infection (positive for HIV 1/2 antibodies).
- People with untreated, active hepatitis B, defined as a positive HBsAg result with a detectable HBV viral level above the normal upper limit — noting that people with hepatitis B whose viral load is below 1000 copies/ml (200 IU/ml) may be eligible if they receive anti-hepatitis B treatment throughout the study to prevent viral reactivation; and people with a specific antibody profile (anti-HBc positive, HBsAg negative, anti-HBs negative, HBV viral load undetectable) may be eligible with close monitoring (confirm with trial site).
- People with active hepatitis C infection (positive HCV antibody and detectable HCV-RNA levels).
- People who have received a live vaccine within 30 days before the first dose — noting that injected inactivated flu vaccines are permitted, but live nasal flu vaccines are not.
- Women who are pregnant or breastfeeding.
- People with serious or uncontrolled health conditions, including: significant heart rhythm or electrical problems; unstable chest pain, heart failure, or moderate-to-severe chronic heart failure (NYHA grade 2 or above); a heart attack within the past 6 months; poorly controlled blood pressure (above 140/90 mmHg); a history of non-infectious lung inflammation requiring steroid treatment within the past year, or currently active lung scarring/inflammation; active tuberculosis; active or uncontrolled infections requiring treatment; active diverticulitis, abdominal abscess, or bowel obstruction; liver disease such as cirrhosis or active hepatitis; poorly controlled diabetes (fasting blood sugar above 10mmol/L); significant protein in the urine confirmed by a 24-hour urine test above 1.0g; or a mental health condition that would prevent participation in treatment.
- People with any other medical history, condition, or test result that the trial doctor believes could interfere with the trial results or put the person at risk (confirm with trial site).
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.
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.
Contact this trial
Principal Investigator: Liang Liu, M.D,Ph.D, Tianjin Medical University Cancer Institute and Hospital
Phone: 86-22-23340123
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 3
Registry
ClinicalTrials.gov
Start date
1 December 2024
Est. completion
1 November 2026
Where this trial is recruiting
🇨🇳 China
Primary endpoints
PFS
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 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.