Printed from Voxsanity (voxsanity.com.au) — NCT07229339 — 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
NCT07229339
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 have given their written consent before any study activities begin.
- People aged 18 or older who are willing and able to give informed consent.
- People who have a confirmed diagnosis (from a tissue test) of a specific type of lung cancer called non-squamous NSCLC, with certain genetic changes (mutations) in the EGFR gene — specifically an "exon 20 insertion" mutation or certain uncommon EGFR mutations — confirmed in tissue or blood within 90 days of joining the trial.
- People whose recent scans (a PET-CT scan and a brain MRI, both done within 60 days of enrollment) show lung cancer at stage II, IIIA, or IIIB (N2) only, and who have also had a bronchoscopy or mediastinoscopy procedure to check lymph nodes in the chest.
- People who have not previously received any systemic treatment (such as chemotherapy or targeted therapy) for lung cancer.
- People whose thoracic surgeon has determined that their cancer can be safely removed by surgery.
- People who have at least one measurable area of cancer, as assessed by standard medical criteria (RECIST 1.1).
- People with a good general level of physical function, rated 0 or 1 on a standard scale used in cancer trials (ECOG scale), meaning they are fully active or have only minor restrictions in physically demanding activity.
- People whose blood test results show adequate levels of white blood cells (neutrophils at or above a specified level).
- People whose blood test results show adequate platelet counts (at or above a specified level).
- People whose haemoglobin (a measure of red blood cells) is at an adequate level without needing recent blood transfusions or certain medications to boost it.
- People whose kidneys are functioning adequately, as measured by a standard calculation of kidney filtration rate.
- People whose liver function blood tests (bilirubin, AST, and ALT) are within acceptable ranges, with a specific exception allowed for people with a condition called Gilbert's disease.
- People whose blood clotting test results are within acceptable ranges, or within the intended treatment range if they are already taking blood-thinning medication.
- People who are able and willing to follow all study requirements.
- People who are not pregnant or breastfeeding, and who agree to avoid pregnancy or breastfeeding from the first study visit until at least one month after the last dose of zipalertinib or six months after the last dose of chemotherapy, whichever is later (applies to female participants).
- People whose lungs are functioning adequately, meaning they do not require supplemental oxygen.
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 are currently participating in another clinical trial that involves a treatment, unless they are only in a follow-up phase or an observational study; also, people who have received any anti-cancer treatment within 30 days before starting this trial.
- People who have received a live virus vaccine (including live-attenuated vaccines) within 30 days before the first dose of study treatment, or an inactive or non-replicating vaccine within 3 days before the first dose.
- People with a history of a primary immune system deficiency condition.
- People whose lung cancer is a mixed type involving both small cell and non-small cell cancer.
- People whose lung cancer is at stage I, IIIB (N3), IIIC, IVA, or IVB, including cancer that has spread to the lining of the brain and spinal cord or to the brain or central nervous system.
- People with a history of lung inflammation (pneumonitis) not caused by infection that required steroid treatment, a history of interstitial lung disease, pneumonitis related to a previous treatment, or any currently active interstitial lung disease.
- People who are unable to swallow tablets, or who have a condition that could significantly affect how the body absorbs the study drug zipalertinib through the digestive system (such as active inflammatory bowel disease, a malabsorption condition, or previous surgery to remove part of the digestive tract).
- People with a history of another cancer diagnosed within the past two years, with certain exceptions for cancers that were fully treated with no known active disease and low risk of return, or specific early-stage or non-invasive cancers that were adequately treated with no sign of active disease (confirm with trial site for full details of exceptions).
- People who have been diagnosed with a bone marrow condition called myelodysplastic syndrome (MDS) that currently requires active treatment.
- People who have had an organ transplant from another person (allogeneic transplant).
- People with a known allergy or sensitivity to carboplatin, pemetrexed, or any ingredients in zipalertinib.
- People who have had a heart attack or significant heart failure symptoms within the 3 months before the first dose of study treatment.
- People who have had a stroke or a transient ischemic attack (sometimes called a "mini-stroke") within the 3 months before the first dose of study treatment.
- People with a history of seizures that are not well controlled.
- People with an HIV infection, unless they are on antiviral therapy with an undetectable viral load — in that case, participation may be possible but requires regular monitoring throughout the study (confirm with trial site).
- People with an active hepatitis C infection (defined as having both a positive hepatitis C antibody test and a detectable hepatitis C virus level in the blood); people with a positive antibody test but undetectable virus level may be eligible (confirm with trial site).
- People with an active hepatitis B infection (defined as having the hepatitis B surface antigen present and a detectable hepatitis B virus level in the blood); people with certain resolved or inactive hepatitis B infection patterns may be eligible but would require regular monitoring and possible preventive treatment throughout the study (confirm with trial site).
- People who have any other condition, illness, infection, or health issue that, in the opinion of the study doctor, would prevent safe participation, create undue risk, or make it difficult to interpret the safety results of 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.
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.
Contact this trial
Principal Investigator: Arjan Gower, MD, UCLA / Jonsson Comprehensive Cancer Center
Phone: 4243871086
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
Registry
ClinicalTrials.gov
Start date
1 June 2027
Est. completion
1 June 2029
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Major pathologic response
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 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.