Printed from Voxsanity (voxsanity.com.au) — NCT06319950 — 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
NCT06319950
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 80 years old.
- People diagnosed with a specific type of lung cancer (non-small cell lung cancer, or NSCLC) that is mainly of the adenocarcinoma type, and that has spread to the brain with at least one measurable lesion there.
- People whose tumor tissue or blood sample has tested positive for a gene change called EGFR (including rare types), as confirmed by an approved hospital or testing facility — the tissue used for testing must not come from a tumor area that has already been treated with radiation, although tissue from a new lesion that appeared after local treatment is acceptable.
- People who have not previously received systemic (whole-body) anti-cancer treatment for advanced or metastatic NSCLC — though people who received first-line chemotherapy without ever receiving a type of drug called a TKI may still be considered; people who had surgery, chemo-radiotherapy, or adjuvant therapy for early-stage NSCLC may also be considered if their cancer has since come back or spread.
- People whose brain metastases are stable and do not require immediate or planned local treatment to the brain during the study.
- People who have at least one tumor lesion that has not been treated with local therapy (such as radiotherapy), can be clearly measured at the start of the study, and measures at least 10mm in its longest dimension (or at least 15mm in the short dimension for lymph nodes) — lesions that did receive prior local treatment may only be counted if the cancer progressed more than 6 months after that treatment ended.
- People with a good general performance level (ECOG score of 0 or 1), whose condition has not worsened in the 2 weeks before joining, and who are expected to live at least 3 months.
- People whose blood test results meet all of the following standards for bone marrow, liver, kidney, and clotting function: neutrophil count ≥1.5×10⁹/L and white blood cell count ≥3×10⁹/L; platelet count ≥100×10⁹/L; haemoglobin ≥90g/L; creatinine ≤1.5 times the upper normal limit and kidney filtration rate ≥50 mL/min; liver enzymes (AST and ALT) ≤2.5 times the upper normal limit (or ≤5 times for people with liver metastases); bilirubin ≤1.5 times the upper normal limit (or ≤3 times for people with liver metastases or a condition called Gilbert syndrome); and clotting measures INR ≤1.5 and APTT ≤1.5 times the upper normal limit.
- People of reproductive age (both male and female) who are willing to use adequate contraception from the time of signing the consent form until 3 months after the last dose of study treatment; women of childbearing age must also have a negative pregnancy test within 7 days before the first dose.
- People who have fully recovered from any side effects of previous treatments (down to grade 1 or below) before starting the study drug — hair loss and grade 2 nerve-related side effects from previous platinum chemotherapy are exceptions to this requirement.
- People who are able to understand the study and are willing to sign a written consent form before any study procedures begin.
- People who are able and willing to complete all study procedures and follow-up visits as required by the study.
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 been treated with any EGFR TKI (a specific type of targeted therapy drug).
- People who have previously received any systemic anti-cancer treatment — such as targeted therapy, biological therapy, or immunotherapy — for advanced or metastatic NSCLC.
- People who received standard chemotherapy within 28 days before the first study dose, or anti-cancer treatment using traditional Chinese medicine within 7 days before the first study dose.
- People who have previously had whole-brain radiation therapy (WBRT); who received radiation to more than 30% of their bone marrow, or extensive radiotherapy, within 28 days before the first study dose; or who received local radiotherapy (such as to the chest or ribs) or palliative radiotherapy for bone metastases within 7 days before the first study dose.
- People with fluid build-up around the lungs, abdomen, or heart that cannot be controlled.
- People with cancer-related pain that cannot be controlled, or who have not yet reached a stable dose of strong pain medication at the time of enrolment.
- People who have had major surgery within 28 days before the first study dose (confirm with trial site for the specific definition of major surgery used).
- People who have taken strong medications that significantly affect how a liver enzyme called CYP3A4 works (including certain herbal medicines) within 14 days before the first study dose, or who would need to continue taking such medications during the study.
- People who are currently taking and need to continue taking medications known to affect heart rhythm in a specific way (QT interval prolongation) or that may cause a serious irregular heartbeat called torsades de pointes.
- People who have participated in another clinical drug trial within 28 days before the first study dose (non-interventional studies are excepted).
- People with primary brain tumours or unstable brain metastases — including those who need emergency brain surgery for complications, those who needed high-dose steroids, mannitol, or diuretics to manage brain metastasis symptoms within 14 days before the first dose, those who received brain radiotherapy or gamma knife treatment within 14 days before the first dose, and those with cancer that has spread to the membranes lining the brain (meningeal metastasis).
- People who have had or currently have another cancer diagnosis within the past 5 years — exceptions include certain fully cured skin cancers (basal cell or squamous cell), papillary thyroid cancer, cervical carcinoma in situ, and ductal carcinoma in situ of the breast.
- People experiencing spinal cord compression caused by the tumour.
- People with significant digestive system problems that could affect the absorption of the study drug — such as being unable to swallow oral medication, severe or hard-to-control nausea or vomiting, a history of major bowel removal surgery, uncontrolled ongoing diarrhoea, atrophic gastritis diagnosed before age 60, an untreated stomach condition requiring long-term acid-suppressing medication, Crohn's disease, or ulcerative colitis.
- People with any of the following heart or blood vessel conditions: a resting heart rhythm measure (QTc) of 470ms or more on average across three ECG readings; significant abnormalities in heart rhythm, electrical conduction, or heart tracing pattern (such as complete left bundle branch block, second or third degree heart block, or a PR interval greater than 250ms); factors that increase the risk of abnormal heart rhythm, including heart failure, low potassium, congenital long QT syndrome, a family history of long QT syndrome, or a close relative who died suddenly and unexpectedly before age 40; a heart pumping function (LVEF) below 50%; a history in the past 6 months of reduced heart muscle function or related symptoms such as chronic congestive heart failure, fluid in the lungs, or reduced ejection fraction; or a history in the past 6 months of heart attack, severe or unstable chest pain, stroke, brain haemorrhage, or mini-stroke (TIA).
- People who test positive for HIV, syphilis, hepatitis C (HCV), or hepatitis B (HBV) under the following conditions: hepatitis B surface antigen positive with a viral load above a specified level; positive hepatitis C antibody and active hepatitis C virus in the blood; or HIV antibody positive.
- People with a current or past history of a lung condition called interstitial lung disease (ILD), drug-induced ILD, radiation-related lung inflammation requiring steroid treatment, any active signs of ILD, or other lung symptoms or risk factors that the study investigator considers unsuitable for participation.
- People who have previously had an allogeneic bone marrow transplant (a transplant using donor bone marrow).
- People who are pregnant or breastfeeding.
- People with any other unstable illness or medical condition that could affect their safety or ability to follow the study requirements — including autoimmune disease requiring steroid treatment, uncontrolled high blood pressure (systolic ≥150 mmHg or diastolic ≥95 mmHg), uncontrolled diabetes, active bleeding, eye conditions, or serious mental, neurological, heart, or breathing conditions.
- People with a known or suspected allergy to the study drug or similar substances.
- People whom the study investigator considers unsuitable for participation 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.
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
Phone: 13867622009
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
Taizhou Hospital
Registry
ClinicalTrials.gov
Start date
1 April 2024
Est. completion
30 December 2026
Primary endpoints
progression free survival(PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 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.