Phase 2 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
- Adults aged 18 or older who have signed a consent form before any trial-related procedures begin.
- People with a confirmed diagnosis (through tissue or cell testing) of non-small cell lung cancer (NSCLC) that cannot be surgically removed and has either spread locally or to other parts of the body.
- People whose NSCLC has one or more specific gene changes (mutations) in the EGFR gene.
- People who have at least one measurable tumor that can be tracked using standard imaging guidelines (called RECIST v1.1), as assessed by the treating doctor.
- People with a general health score of 0 or 1 on a standard scale used by cancer researchers (ECOG), meaning they are fully active or have only minor limitations in physical activity.
- People with a life expectancy of at least 12 weeks.
- People whose blood counts and organ function (such as liver and kidneys) meet the levels required by the trial protocol.
- Women who could become pregnant must have a negative pregnancy test (blood and/or urine) within 7 days before receiving the first dose of the trial treatment.
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 recently received certain treatments before the first dose, including: a targeted EGFR therapy (EGFR-TKI) within the past 8 days; immunotherapy or biological therapy within the past 4 weeks; radiotherapy within the past 4 weeks (though palliative radiotherapy finished at least 2 weeks before may be acceptable — confirm with trial site); herbal therapies with anti-tumour effects within the past 2 weeks; specific chemotherapy drugs called mitomycin or nitrosourea within the past 6 weeks; oral fluorouracil-type drugs (such as tegafur or capecitabine) within the past 2 weeks; other chemotherapy or anti-tumour drugs for NSCLC within the past 4 weeks; or any approved or experimental treatment targeting a specific mutation called EGFR C797S.
- People who are currently taking part in another clinical trial using an experimental treatment or device, or who have done so within 4 weeks before the first dose.
- People who are expected to need any other type of anti-tumour treatment during the trial.
- People who still have side effects from previous cancer treatment that have not resolved to a mild level (above Grade 1 on a standard side effect scale) before the first dose.
- People with a history of serious eye or skin disease that has not recovered to a mild or absent level before the first dose.
- People who have had certain heart conditions within the past 6 months, including an abnormal heart rhythm measurement (QTc interval of 470 milliseconds or more) or other significant cardiovascular events (confirm with trial site for full list).
- People with a medical history of a lung condition called interstitial lung disease (ILD).
- People with digestive system problems that may affect their ability to swallow tablets or absorb the trial medication, or who have had a serious digestive illness within the past 4 weeks that has not sufficiently recovered.
- People who have had major surgery or a serious injury within the past 4 weeks before the first dose, or who are expected to need major surgery during the trial.
- People who have had a tendency to bleed abnormally or a blood clotting disorder within the past 6 months.
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.
Contact this trial
Phone: 13281126921
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
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
Dose escalation and dose expansion: Incidence of dose-limiting toxicities (DLTs), Incidence and severity of treatment-emergent adverse events (TEAEs) with severity determined according to National Cancer Institute (NCI) CTCAE v5.0; Cohort expansion: Objective Response Rate (ORR); Cohort expansion: Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.