Printed from Voxsanity (voxsanity.com.au) — NCT06250777 — 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, By Invitation
NCT06250777
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 aged 20 years or older.
- People who have been diagnosed with a specific type of lung cancer (non-squamous non-small cell lung cancer, or NSCLC) that has been confirmed by a laboratory test on a tissue sample, and whose cancer is either locally advanced and cannot be removed by surgery or treated with the aim of a cure, or has come back after previous treatment, or has already spread to other parts of the body at the time of diagnosis. People with mixed tumour types may be eligible if the main type found is adenocarcinoma.
- People whose cancer has a specific genetic change (called an activating HER2 mutation) found through a type of genetic test (NGS) on either a tissue or blood sample, including specific mutations in certain parts of the HER2 gene (confirm with trial site for exact mutation types).
- People whose cancer tissue shows a certain level of HER2 protein expression on a laboratory test (called IHC), at levels of 1+, 2+, or 3+.
- People who have brain metastases (cancer that has spread to the brain) that are not causing symptoms and do not need treatment, or whose brain metastases have been treated and are stable, meaning no steroids or anti-seizure medications are needed to control symptoms.
- People who have already received and not responded to a platinum-based chemotherapy treatment.
- People whose cancer can be measured using standard imaging guidelines (RECIST version 1.1 or RANO criteria).
- People whose heart pumping function (called LVEF) is measured at 50% or above within 28 days before joining the trial.
- People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are either fully active or have mild limitations but are able to carry out light work.
- People whose blood tests show that the bone marrow, liver, and kidneys are working adequately within 14 days before joining the trial, specifically: platelet count of at least 100,000/mm³; haemoglobin of at least 9.0 g/dL; neutrophil count of at least 1,500/mm³; liver enzyme levels (ALT and AST) within acceptable ranges; bilirubin within acceptable ranges; blood albumin of at least 2.5 g/dL; and kidney filtration rate of at least 30 mL/min as calculated by a standard formula.
- People whose blood clotting function tests are within acceptable ranges (within 1.5 times the upper limit of normal).
- People who have waited long enough after their previous treatments before joining the trial, including at least 4 weeks after major surgery or chest radiation, at least 2 weeks after certain types of palliative brain or bone radiation, at least 3 weeks after certain chemotherapy or immunotherapy, at least 4 weeks after antibody-based cancer treatments, at least 2 weeks (or 5 half-lives, whichever is longer) after targeted therapies or small molecule drugs, and at least 1 week after TKI (tyrosine kinase inhibitor) treatments used for NSCLC, with a baseline scan completed after stopping TKI treatment (confirm with trial site for exact washout periods, as some figures in the source document appear to contain formatting errors).
- Women who are past menopause or who have a negative pregnancy blood test before joining and before each dose of the study drug, if they are of childbearing potential and sexually active with a male partner who has not had a vasectomy. Women are considered past menopause if they are over 60 years old or have had no periods for 12 months with no other medical cause.
- Women of childbearing potential who are sexually active with a non-sterilised male partner must use at least one highly effective method of contraception from screening until 7 months after the last dose of the study drug, and must not breastfeed during this time. Continuous abstinence from sex (if consistent with the person's usual lifestyle) is also acceptable, but periodic abstinence, the rhythm method, and the withdrawal method are not.
- Male participants who have not had a vasectomy and are sexually active with a female partner who could become pregnant must use a condom with spermicide from screening until 4 months after the last dose of the study drug. Continuous abstinence (if consistent with the person's usual lifestyle) is also acceptable, but periodic abstinence, the rhythm method, and the withdrawal method are not. It is strongly recommended that the female partners of male participants also use at least one highly effective contraceptive method during this time. Male participants should not attempt to father a child or donate or freeze sperm from the time of joining the trial until 4 months after the last dose, though sperm preservation before joining may be considered.
- Female participants must not donate or retrieve eggs for their own use from the time of joining the trial through to at least 7 months after the last dose of the study drug, and should not breastfeed during this time. Egg preservation before joining may be considered.
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 active brain metastases that need medical treatment or intervention.
- People whose cancer has spread to the membranes lining the brain and spinal cord (called leptomeningeal metastases).
- People who have received systemic cancer treatment (such as targeted therapy) within 28 days, or within 2 weeks or 5 half-lives (whichever is longer for targeted therapies), before starting the study drug.
- People who have had radiation therapy (not including certain types of palliative stereotactic radiation to the chest) or gamma-knife surgery within 2 weeks before starting the study drug.
- People who have substance use issues or other medical conditions — such as significant heart or mental health conditions — that the study doctor believes may interfere with participation or the reliability of study results.
- People who have compression of the spinal cord, or brain or nervous system metastases that are untreated and causing symptoms, or that require steroids or anti-seizure medications. People with untreated but symptom-free brain metastases, or treated brain metastases that are no longer causing symptoms and no longer need steroids or anti-seizure medications, may still be considered, provided they have recovered from any side effects of radiotherapy and at least 2 weeks have passed since whole brain radiotherapy ended.
- People who still have unresolved side effects from previous cancer treatments, other than hair loss, that have not returned to mild levels (Grade 2 or lower) or to their level before treatment.
- People who have had a heart attack within the 6 months before joining, or who have significant heart failure causing symptoms (classified as Class II to IV by the New York Heart Association).
- People who have a history of non-infectious lung inflammation (ILD or pneumonitis) that needed steroid treatment, currently have this condition, or where this condition cannot be ruled out on imaging done during screening.
- People who have an active infection that is not under control and requires intravenous antibiotics, antivirals, or antifungal medications. (Use of preventive antibiotics is allowed.)
- People with active immune system deficiency, uncontrolled HIV infection, or active hepatitis B or C infection. People with a past hepatitis B infection may still be considered if certain blood test results meet specific criteria (confirm with trial site). People with hepatitis C antibodies may be considered only if a specific additional test (PCR for HCV RNA) is negative. HIV testing may be required depending on local rules.
- People who have received a live, weakened (attenuated) vaccine within 30 days before the first dose of the study drug. (mRNA vaccines and certain adenoviral vaccines are not considered live attenuated vaccines.) Participants who join must not receive live vaccines during the study or for up to 30 days after the last dose.
- People who have significant fluid build-up around the lungs, in the abdomen, or around the heart that requires draining (confirm with trial site regarding stable cases).
- People with significant ongoing lung conditions, including but not limited to a blood clot in the lung within the 3 months before joining, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or significant fluid around the lungs.
- People with autoimmune, connective tissue, or inflammatory conditions (such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis) where there is known or suspected involvement of the lungs at the time of screening.
- People who have previously had an entire lung surgically removed (complete pneumonectomy).
- People with a known allergy or sensitivity to the study drug or any of its ingredients.
- People with a history of severe allergic reactions to other monoclonal antibody treatments.
- People who are pregnant, breastfeeding, or planning to become pregnant.
- People who have had more than one type of cancer within the past 3 years, with the exception of certain skin cancers that have been adequately treated, cancers in place (in-situ disease) that have been cured, or other solid tumours that have been treated with curative intent.
- People who have previously been treated with targeted HER2 therapies, with the exception of TKI (tyrosine kinase inhibitor) treatments.
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.
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Trial details
Status
By Invitation
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
11 July 2024
Est. completion
1 December 2026
Where this trial is recruiting
🇰🇷 South Korea
Primary endpoints
Median Intracranial Progression-free survival(icPFS) as defined by RANO criteria
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 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.