Phase 1 Lung Cancer Trial, Not Yet Recruiting
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 with advanced or metastatic non-small cell lung cancer (a type of lung cancer that has spread) that has a specific genetic change called EGFR-L858R, and whose cancer has not responded to standard treatments, who cannot tolerate standard treatments, have no remaining standard treatment options, or who have chosen not to have standard treatment.
- In a specific group called Cohort A (part of a later phase of the trial): people with the same type of lung cancer and EGFR-L858R mutation whose cancer continued to grow after treatment with a third-generation EGFR-blocking drug, and who also have certain additional genetic changes (such as C797S, L718Q, G724S, or S768I) (confirm with trial site).
- In a specific group called Cohort B (part of a later phase of the trial): people with the same type of lung cancer and EGFR-L858R mutation who have not responded to, cannot tolerate, or have refused standard treatment — people with the additional genetic changes listed above are directed to Cohort A first.
- People who have detectable tumour areas that can be assessed by scans, with the exact requirement depending on which phase of the trial a person is being considered for (confirm with trial site).
- People aged 18 years or older, of any gender.
- People expected to live for at least 12 weeks.
- People who are generally well enough to carry out light activity and care for themselves, as measured by a standard scale called the ECOG performance status score of 0 or 1.
- People whose blood counts, clotting, liver, and kidney function all meet specific minimum levels set by the trial (confirm with trial site for exact values).
- People whose side effects from any previous cancer treatments have largely resolved, generally to a mild level or better, before joining the trial.
- People who have already had their EGFR-L858R mutation confirmed through a local test, and who can provide relevant genetic test results if required based on their treatment history.
- People who are willing to provide blood samples for research purposes, and optionally tissue samples.
- Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding; all participants must agree to use reliable contraception for 1 month before treatment, throughout treatment, and for 3 months after treatment ends.
- People who have read, understood, and signed a consent form agreeing to take part in the trial.
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 received or are currently receiving a type of cancer treatment specifically targeting EGFR-L858R called a PROTAC therapy.
- People who have had cancer treatment too recently before the first dose — the required gap depends on the type of treatment received (confirm with trial site for specific timeframes).
- People who had major surgery or a serious physical injury within 4 weeks before the first dose, or who received radiation therapy within 4 weeks before the first dose (a shorter 2-week gap may be acceptable for certain limited palliative radiation, such as for bone pain — confirm with trial site).
- People with unstable cancer that has spread to the brain or fluid around the brain, or cancer pressing on the spinal cord (people with previously treated and stable brain metastases who have stopped certain medications for at least 2 weeks may be considered — confirm with trial site).
- People who have had another type of cancer in the past 3 years, unless it was fully treated with very low risk of return, or was a specific low-risk type such as certain skin cancers, early-stage cervical changes, or a type of thyroid cancer.
- People with serious heart conditions, including unstable chest pain, recent heart attack, moderate to severe heart failure, certain abnormal heart rhythms requiring treatment, uncontrolled irregular heartbeat, an abnormal electrical reading of the heart (QTcF interval) above set limits, reduced heart pumping function on scan, or high blood pressure not controlled by medication.
- People with a history of scarring or inflammation of the lung tissue (interstitial lung disease or non-infectious pneumonitis).
- People with a condition where the adrenal glands do not produce enough hormones (adrenal insufficiency).
- People who have taken certain medications — including proton pump inhibitors (used for acid reflux), strong inhibitors or inducers of a liver enzyme called CYP3A4, or certain drug-transporter inhibitors or inducers — within 7 days before the first dose (confirm with trial site for specific medications).
- People with a history of ongoing or frequent diarrhoea, conditions that cause it (such as Crohn's disease or irritable bowel syndrome), or any condition that might affect how the body absorbs the study drug, including diarrhoea above a mild level in the week before the first dose.
- People with a known serious allergic reaction to the study drug or any of its ingredients.
- People who have had a serious blood clot in a deep vein, in the lungs, or another major clot-related event within 6 months before the first dose (certain minor or catheter-related clots may be exceptions — confirm with trial site).
- People who have had significant bleeding from the gut or lungs, or any other major bleeding event, within 3 months before the first dose.
- People with significant fluid build-up in body cavities (such as the abdomen, around the lungs, or around the heart) that requires repeated draining and is not under control.
- People who have had a stem cell or bone marrow transplant using their own cells within 3 months, or a transplant using another person's cells or organs within 6 months, before the first dose.
- People with active hepatitis B, hepatitis C, HIV, or active syphilis infection (people with hepatitis B that has been stable for at least 4 weeks on antiviral treatment may be considered — confirm with trial site).
- People with an active infection that requires treatment with systemic (whole-body) medication within 1 week before the first dose.
- People with a history of substance misuse, or any other condition that the trial doctors believe could interfere with safe participation or affect the reliability of the trial results.
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.
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
Primary endpoints
Objective Response Rate (ORR); Maximum Tolerated Dose (MTD); Recommended Phase II Dose (RP2D)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.