Printed from Voxsanity (voxsanity.com.au) — NCT07461727 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Lung Cancer Trial, Not Yet Recruiting
NCT07461727
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 to 75 years, of any sex.
- People with a confirmed diagnosis of non-small cell lung cancer (a type of lung cancer) that cannot be surgically removed and has either spread to nearby areas or to other parts of the body (stage IV).
- People who have previously been treated with a specific type of targeted lung cancer drug called a third-generation EGFR-TKI (such as osimertinib), and whose cancer has since grown or spread as confirmed by scans, or who could not tolerate the drug, with no other cancer treatment taken during that period.
- People for whom a tumour tissue sample taken after their cancer stopped responding to the previous EGFR-TKI drug is available, and that sample (or a blood sample) has been confirmed by a laboratory to carry a specific genetic change called the EGFR L858R mutation.
- People who have at least one measurable tumour in the liver, confirmed by biopsy, with that tumour also confirmed by a laboratory to carry the EGFR L858R genetic change.
- People who are generally well enough to carry out everyday activities with little to no limitation (this is measured using a standard scale called ECOG performance status, scored 0 or 1).
- People whose blood and organ function results meet required levels — including blood cell counts, liver function, kidney function, and blood clotting — tested within 14 days before joining and without recent blood transfusions or growth factor treatment (confirm specific values with trial site).
- People who are willing and able to give written consent to take part, follow the study procedures, and work with the study team.
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 gene-editing treatments, such as CRISPR, TALEN, or ZFN therapies.
- People who have received chemotherapy, radiation, biological therapy, hormone therapy, targeted therapy, immunotherapy, or other cancer treatments within 4 weeks before the first dose of the study drug (or within 2 weeks or 5 half-lives — whichever is longer — for certain oral or small-molecule drugs).
- People who have taken part in another clinical trial or received an unapproved experimental treatment within 4 weeks before the first dose of the study drug.
- People whose cancer has certain other genetic changes known to cause resistance to targeted therapy, apart from specific EGFR mutations — including high levels of certain gene amplifications (MET or HER2), newly appeared resistance mutations (such as KRAS or BRAF-V600E), activating changes in a specific cell signalling pathway (PI3K/AKT/mTOR), or loss of the original EGFR L858R mutation in tumour tissue taken after resistance developed (confirm details with trial site).
- People who have a known allergy or past reaction to any component of a lipid nanoparticle (a type of drug delivery material).
- People with blood pressure that remains too high despite regular medication, or who have a history of severe high blood pressure emergencies or related brain conditions.
- People with liver disease, including cirrhosis (scarring of the liver), active hepatitis, or a history of hepatitis B or C infection.
- People with unstable chest pain (angina) or a heart attack, or a history of either within the past 6 months.
- People with a history of another cancer within the past 5 years, except for certain treated skin cancers (basal cell carcinoma or cutaneous squamous cell carcinoma), cervical cancer, or gastrointestinal cancers.
- People who are pregnant, breastfeeding, have a positive pregnancy test, or are premenopausal women unwilling to use contraception during the study (women are considered postmenopausal after at least 2 years without a menstrual period); also, men who are unwilling to use contraception during the study.
- People with cancer that has spread to the lining around the brain, the brainstem, or the spine, or with active brain metastases causing pressure; people with previously treated brain metastases may still be considered if their condition has been clinically stable for at least 4 weeks before the first dose and they have been off steroid medication for at least 14 days.
- People whom the trial investigator considers unsuitable for participation for any reason.
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: Ning Li, PhD, Chinese Academy of Medical Sciences & Peking Union Medical College
Phone: 13581809307
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Registry
ClinicalTrials.gov
Start date
10 February 2026
Est. completion
1 January 2027
Primary endpoints
Adverse Events (AEs) and Serious Adverse Events (SAEs); Incidence of Dose-Limiting Toxicity (DLT)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 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.