Printed from Voxsanity (voxsanity.com.au) — NCT07244926 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07244926
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 or older, of any gender.
- People with a confirmed diagnosis of a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread, and cannot be cured with treatment (stage IIIB/C or IV).
- People whose lung cancer has tested negative for certain genetic changes (specifically EGFR mutations, ALK fusions, and other gene alterations in ROS1, NTRK, BRAF, MET, KRAS, HER2, or RET).
- People whose cancer got worse after receiving a first treatment combining platinum-based chemotherapy with an immunotherapy medicine (anti-PD-(L)1 therapy).
- People who have at least one tumour that can be measured on scans, according to standard medical guidelines (RECIST v1.1).
- People with a general health rating of 0 or 1 on a standard scale (ECOG), meaning they are fully active or have only minor restrictions, assessed within 7 days before starting the trial.
- People with a life expectancy of at least 12 weeks.
- People whose liver, kidneys, bone marrow, and other organs are functioning well enough to meet the trial's requirements.
- People who agree to use effective contraception from the time of signing the consent form until 6 months after the last dose — this applies to women who could become pregnant and to men whose partners could become pregnant.
- People who are joining the trial voluntarily, are willing to sign a consent form, and are able to attend all required visits and follow the study procedures.
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 is confirmed to be of the squamous cell type, or whose cancer contains small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
- People who have previously received any of the following treatments (including before or after surgery): a) a therapy that targets a protein called TROP2; b) any drug containing a topoisomerase I inhibitor, including certain antibody-drug conjugate (ADC) therapies; c) medicines that block the growth of blood vessels in tumours (anti-angiogenic agents).
- People who need to take strong medicines that significantly affect how the body processes certain drugs (strong CYP3A4 inhibitors or inducers) within 2 weeks before starting the trial or during the study.
- People with a diagnosed severe dry eye condition, severe eyelid gland disease or eyelid inflammation, or a history of corneal problems that slow or prevent healing.
- People with cancer that has spread to the lining of the brain or spinal cord, the brainstem, the spinal cord itself, or who have active brain metastases; people with previously treated brain metastases may be considered if their condition has been stable for at least 4 weeks and they have not needed steroids or anti-seizure medicines for at least 14 days; people with untreated brain metastases that are not causing symptoms may be considered after assessment by the trial doctor (confirm with trial site).
- People who have had another cancer in the past 3 years, except for certain types that are considered fully treated with local therapy (such as some skin cancers or early-stage cervical changes).
- People with serious heart or blood vessel disease, or significant risk factors for such conditions.
- People with uncontrolled ongoing illnesses affecting the whole body, as assessed by the trial doctor.
- People whose urine test shows a high level of protein, confirmed by a 24-hour urine test showing more than 1.0 g of protein.
- People with a history of lung inflammation (interstitial lung disease or non-infectious pneumonitis) that required steroid treatment, or who currently have or are suspected to have this condition.
- People with serious breathing problems caused by other ongoing lung diseases.
- People with active long-term bowel inflammation, a blockage in the digestive tract, a severe ulcer, a hole in the gut wall, an abscess in the abdomen, or active serious bleeding in the digestive tract.
- People whose tumour is pressing on or growing into nearby vital organs or blood vessels in a way that is causing symptoms, or where there is a risk of an abnormal connection forming between the oesophagus and the airway or chest cavity.
- People with a history of abnormal bleeding or blood clotting problems, or who have had significant bleeding or are at high risk of bleeding in the 4 weeks before starting the trial.
- People who have been taking high-dose aspirin (more than 325 mg per day), dipyridamole, or clopidogrel within 2 weeks before starting the trial.
- People who have been taking full-dose blood thinning medicines (anticoagulants) or clot-dissolving medicines (thrombolytics) by mouth or through a vein within 2 weeks before starting the trial.
- People who have had a biopsy or minor surgical procedure (other than placement of a vascular access device) within 7 days before starting the trial.
- People who still have side effects from previous cancer treatments that have not returned to a mild level (Grade 1 or lower), unless the trial doctor considers the ongoing effects to pose a low safety risk (such as hair loss or tiredness).
- People with known active tuberculosis, or those suspected of having active tuberculosis who have not had it ruled out through clinical assessment.
- People who have previously had an organ transplant or bone marrow/stem cell transplant from another person.
- People with active Hepatitis B or Hepatitis C infection (note: people who test positive for the Hepatitis B surface antigen may be required to receive anti-hepatitis B treatment during the trial — confirm with trial site).
- People who test positive for HIV, have a history of AIDS, or have a known active syphilis infection.
- People with a known allergy to the trial drug or any of its ingredients, or who have had a severe allergic reaction to other biological medicines.
- People who have had major surgery within 4 weeks before starting the trial, or who are expected to need major surgery during the study.
- People who have had a serious infection within 4 weeks before starting the trial, or who have an active infection requiring antibiotic or antiviral treatment within 2 weeks before starting.
- People who have received general immune-boosting therapy within 2 weeks before starting the trial.
- People who have had high-dose radiation to lung tumours (more than 30 Gy) within 6 months before starting, or high-dose radiation to other areas or extensive radiation treatment within 4 weeks before starting; palliative radiotherapy for symptom relief is generally allowed if completed at least 2 weeks before the first dose.
- People who have received a live vaccine within 30 days before starting the trial, or who plan to receive a live vaccine during the study.
- People whose condition is deteriorating rapidly during the screening period before the trial begins.
- Women who are pregnant or breastfeeding.
- People with serious non-cancer conditions or symptoms related to the tumour that could create high medical risk or make it difficult to assess survival outcomes.
- People who, in the trial doctor's judgement, have any other condition that could interfere with the trial results, raise safety concerns, or make participation inappropriate for any 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.
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: Xiubao Ren, MD. 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 2
Registry
ClinicalTrials.gov
Start date
1 December 2025
Est. completion
1 June 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective response rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.