Printed from Voxsanity (voxsanity.com.au) — NCT07549061 — 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
NCT07549061
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 sign a consent form and are able to attend study visits and follow study procedures.
- Adults aged 18 years or older, of any sex.
- People who have been diagnosed with non-small cell lung cancer (a type of lung cancer) confirmed by a pathology report, including reports from outside hospitals.
- People with newly diagnosed advanced (metastatic, Stage IVA or IVB) or returned (recurrent) non-small cell lung cancer that cannot be treated with surgery or radiotherapy aimed at a cure.
- People who have not yet received treatment for their advanced lung cancer, or — for those whose cancer has returned — people who completed earlier treatments (such as chemotherapy, radiotherapy, immunotherapy, or similar therapies) at least 12 months before the cancer came back.
- People whose general health and ability to carry out daily activities falls within a certain range, measured by a standard medical score of 0, 1, or 2 (confirm with trial site).
- People whose lung cancer does not have certain gene changes (such as EGFR, ALK, ROS1, KRAS G12C, or MET exon 14 mutations), confirmed by tumour tissue or blood test — though a specific type of MET gene amplification is allowed (confirm with trial site).
- People whose tumour shows a high level of a protein called MET, found through a laboratory staining test, with at least half of the tumour cells showing a strong positive result.
- People who are estimated to have a life expectancy of at least 3 months.
- People whose blood test results meet specific requirements for blood cell counts, liver function, and kidney function (confirm with trial site for exact values).
- People who are able and willing to use highly effective contraception from signing the consent form until 3 months after the last dose of the study drug; for women who could become pregnant, a negative pregnancy blood test within 7 days before the first dose is also required.
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 spinal cord compression, or who have brain metastases (cancer that has spread to the brain) that are causing symptoms or are unstable, unless certain conditions are met, such as completing curative treatment and remaining neurologically stable for at least 2 weeks (confirm with trial site).
- People who have had major surgery (such as surgery inside the chest, abdomen, or pelvis) within 4 weeks before enrolling, or who have not yet recovered from such surgery — though certain smaller procedures (such as biopsy by keyhole or mediastinoscopy) are only subject to a 1-week wait.
- People who have received traditional Chinese medicine or Chinese patent medicine with anti-tumour indications within 1 week before the first dose of the study drug.
- People who are taking strong medications that significantly affect how the body processes certain drugs (strong CYP3A4 inducers or inhibitors) and who are unable to stop taking them for at least 1 week before starting the study treatment and throughout the study.
- People who have previously received systemic anti-cancer treatment (such as chemotherapy, immunotherapy, or similar) for advanced non-small cell lung cancer — except where earlier treatments for recurrent disease were completed at least 12 months before the cancer returned.
- People who have received radiation therapy covering more than 30% of the bone marrow, or large-area radiation therapy within 4 weeks before the first dose of the study drug.
- People with brain lesions that urgently need local treatment for symptom relief, at the judgement of the treating doctor.
- People with severe or uncontrolled health conditions — including serious physical illnesses, psychiatric disorders, or abnormal test results — that the treating doctor determines make the study drug unsuitable or make it difficult to follow the study requirements.
- People with certain heart-related issues, including: an abnormal heart rhythm measurement (QTc interval greater than 470 ms on ECG); significant irregular heart rhythms such as certain types of heart block or uncontrolled arrhythmias; known risk factors for heart rhythm problems such as persistently low potassium, a hereditary heart condition, or use of medications known to affect heart rhythm; or heart failure classified as moderate to severe (NYHA Class 3 or higher), unstable chest pain, or poorly controlled high blood pressure (confirm with trial site for exact values).
- People who have been diagnosed with another active cancer requiring treatment within the past 3 years — except for completely removed skin cancers (basal cell or squamous cell) or completely removed early-stage (in situ) cancers of any type.
- People with active infections, including: active hepatitis B with a high viral load, active hepatitis C, HIV, or syphilis; active tuberculosis; or any active infection requiring systemic antibiotic or antiviral treatment within 2 weeks before the first dose.
- People with a history of a lung condition called interstitial lung disease (ILD), drug-related ILD, or radiation-related lung inflammation that required steroid treatment, or who currently have active lung abnormalities needing medical treatment.
- People with active digestive system problems — such as ulcers, uncontrolled nausea, vomiting, diarrhoea, or difficulty absorbing food — or other conditions (including an inability to swallow tablets or prior major stomach or bowel surgery) that could significantly affect how the body absorbs the study drug.
- People with a known allergy or hypersensitivity to the study drug or similar drugs, or to any of its ingredients.
- People with any other medical condition that may increase the risk of side effects from the study drug.
- People who are pregnant or breastfeeding.
- People who are currently taking part in another clinical trial or who have received an experimental treatment within 2 weeks before the first dose of the study drug.
- People whom the treating doctor considers unsuitable for any other reason, including those with severe immune system disorders or who have received an organ transplant from a donor.
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
Principal Investigator: Wei Nie, Shanghai Chest Hospital
Phone: 021-63846590
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
Shanghai Chest Hospital
Registry
ClinicalTrials.gov
Start date
30 March 2026
Est. completion
30 May 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective Response Rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 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.