Phase 3 Lung Cancer Trial, By Invitation
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 able to understand and are willing to sign a written consent form.
- People who are aged 18 years or older.
- People who have been confirmed by laboratory testing to have locally advanced or metastatic non-small cell lung cancer (a type of lung cancer that has spread or cannot be removed, at stage IIIB to IV).
- People whose tumor tissue has tested positive for a specific genetic change called EGFR exon 20 insertion, confirmed by an accredited laboratory using approved genetic testing methods.
- People who have at least one measurable area of cancer (as defined by standard measurement guidelines), not counting any lesions in the brain.
- People with a general health and activity level score of 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
- People who are expected to live for at least 12 weeks.
- People who have not previously received any systemic (whole-body) treatment for locally advanced or metastatic non-squamous cell lung cancer, though people who received early-stage preventative or post-surgery treatment may be considered if that treatment ended at least 6 months before the cancer was found to have spread or progressed.
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 any of the following treatments before the first dose of the study drug: any anti-EGFR targeted therapy specifically for this type of genetic mutation; certain traditional Chinese medicines with anti-cancer indications within 1 week before the first dose; a diabetes medication called metformin within 1 week before or during the study; strong medications that significantly affect how the body processes certain drugs (strong CYP3A4 inhibitors or inducers) within 1 week before or during the study; immune-suppressing medications within 2 weeks before or during the first dose; major surgery within 4 weeks before starting the study drug (except certain lung-related diagnostic procedures within 7 days); or radiotherapy to the lungs or whole brain within 4 weeks, or to any other body area within 2 weeks before starting, unless the person has fully recovered from any side effects (routine palliative radiotherapy for bone pain is not included).
- People who have cancer that has spread to the spinal cord or the lining of the brain, or who have active brain-related symptoms that are unstable or have required increasing doses of steroids in the 2 weeks before joining the study.
- People who have not yet recovered from side effects or complications of previous cancer treatments (such as chemotherapy, surgery, or radiotherapy) to a mild or resolved level before joining, except for hair loss or permanent damage from radiation that cannot be reversed.
- People who have not recovered from side effects or complications of previous anti-cancer treatments to a mild or resolved level, except for hair loss or permanent radiation damage that cannot be reversed.
- People who have a tendency to bleed or clot abnormally, or who have had a serious blood clot or cardiovascular event (such as a heart attack, unstable chest pain, stroke, mini-stroke, blood clot in the lungs, or deep vein clot) within 6 months before joining; or people considered by the medical team to be at risk of serious bleeding or who have had major blood vessel involvement.
- People with serious heart conditions, such as significant irregular heartbeats, heart failure rated at grade III or higher on a standard scale, or a heart pumping function below 50% on an ultrasound scan.
- People whose heart electrical activity (specifically a measurement called QTcF interval) averages more than 470 milliseconds across three resting heart tests during screening.
- People with uncontrolled high blood pressure, where blood pressure remains above 160/100 mmHg even with treatment.
- People who have difficulty swallowing, or who have active digestive conditions or have had major stomach or bowel surgery that could affect how the study drug is taken in or absorbed (such as open ulcers, uncontrolled nausea, vomiting, diarrhoea, or poor nutrient absorption).
- People who are allergic to or cannot tolerate the study drug or any of its ingredients.
- People who are pregnant or currently breastfeeding.
- People who have received a live vaccine within 4 weeks before joining the study.
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
Where this trial is recruiting
Primary endpoints
Progression-Free Survival (PFS) by BICR
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.