Printed from Voxsanity (voxsanity.com.au) — NCT07197008 — 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
NCT07197008
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 80 years old at the time of signing the consent form, of any gender.
- People whose lung cancer has been confirmed by laboratory testing to be a non-squamous, non-small cell type with a specific gene change in the EGFR gene (a deletion in exon 19 or a change called L858R in exon 21).
- People whose cancer has continued to grow or spread during or after treatment with a third-generation EGFR-targeted therapy (this includes people who were treated with first- or second-generation EGFR-targeted therapies before switching to a third-generation one, or those who started with a third-generation therapy from the beginning).
- People who have cancer that has spread to the brain, confirmed by MRI, where the brain metastases either cause no symptoms, or where symptoms have been brought under control with local treatment and/or medication — and the condition has been stable for at least 2 weeks before starting the trial, without needing steroids or seizure medications.
- People who have at least one measurable brain tumour lesion (5 mm or larger in diameter) that has not previously been treated with radiation or surgery, as assessed using standard imaging guidelines.
- People with a good general level of daily functioning, rated 0 or 1 on a standard medical scale (confirm with trial site).
- People with an estimated life expectancy of 12 weeks or more.
- People whose liver, kidneys, and other organs are functioning adequately (confirm with trial site).
- Women who could become pregnant, and men whose partners could become pregnant, who agree to use effective contraception from the time of signing the consent form until 6 months after the last dose.
- People who are willing to take part, sign the consent form, and are able to attend the required visits and follow the study procedures.
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 whose lung cancer contains components of small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or squamous cell carcinoma, confirmed by laboratory testing.
- People who have cancer pressing on the spinal cord, or who are assessed by the trial doctor as having widespread spread of cancer to the membranes surrounding the brain and spinal cord.
- People who have previously had whole-brain radiation therapy for brain metastases.
- People who have previously received chemotherapy, any therapy targeting a protein called TROP2, or any drug treatment containing a type of substance called a topoisomerase I inhibitor — including certain antibody-drug treatments — whether given as a main treatment or before/after surgery.
- People whose tumour is growing into or wrapping around important nearby organs or blood vessels (such as the heart, food pipe, or major veins), or whose tumour shows significant breakdown, cavity formation, or is at risk of creating an abnormal connection between the food pipe and airway or chest cavity.
- People who have had significant bleeding problems or a blood clotting disorder, or who have had clinically significant bleeding symptoms or risks within 4 weeks before starting the trial.
- People who have taken high-dose aspirin (more than 325 mg per day), dipyridamole, or clopidogrel within 2 weeks before starting the trial.
- People who have taken full-dose blood-thinning medications (oral or intravenous anticoagulants or clot-dissolving drugs) within 2 weeks before starting the trial.
- People who have had a biopsy or minor surgical procedure (not including placement of a drip or port device) within 7 days before starting the trial.
- People who have wounds that have not healed, or untreated broken bones (not including old fractures or fractures that do not require treatment).
- People who have had another cancer diagnosis within the 3 years before starting the trial — except for certain cancers that have been fully treated with local therapies, such as some skin cancers or early-stage cervical changes (confirm with trial site).
- People with certain heart or blood vessel conditions, including: a heart attack, unstable chest pain, acute or ongoing lack of blood supply to the heart, moderate-to-severe heart failure, serious or poorly controlled irregular heartbeat, stroke, or mini-stroke within the 6 months before starting the trial.
- People with a previous history of heart muscle diseases such as inflammation of the heart muscle, or certain types of heart muscle disorders.
- People who have had a blood clot in a deep vein, a blood clot in the lungs, blockage of arteries in the limbs, or other serious clotting events within 3 months before starting the trial — unless the condition has been stable with appropriate blood-thinning treatment for at least 2 weeks (confirm with trial site).
- People who have had a serious blood vessel condition requiring surgery — such as a large bulge or tear in the main artery — within 6 months before starting the trial.
- People with uncontrolled systemic (whole-body) diseases, as assessed by the trial doctor (confirm with trial site).
- People who have a history of, or currently have, lung inflammation or scarring (interstitial lung disease or non-infectious pneumonia) that required steroid treatment, or where such a condition is suspected at screening and cannot be ruled out by imaging.
- People with a documented history of severe dry eye, severe eyelid gland disease, severe blepharitis, or serious corneal conditions that could interfere with healing of the eye surface.
- People with serious lung damage from existing lung conditions — including severe asthma, severe chronic obstructive pulmonary disease (COPD), restricted lung function within 3 months before starting the trial, autoimmune or inflammatory conditions that affect the lungs (such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis), or people who have had a lung surgically removed.
- People with active inflammatory bowel disease, a blocked bowel, severe ulcers, a hole in the bowel wall, an abscess in the abdomen, or acute gastrointestinal bleeding.
- People with significant protein in their urine, as measured by urine testing (confirm with trial site for specific threshold details).
- People whose side effects from previous cancer treatments have not recovered to a mild level or better before starting the trial (confirm with trial site).
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
Phone: +8613798019964
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 2
Sponsor
Li-kun Chen
Registry
ClinicalTrials.gov
Start date
1 October 2025
Est. completion
30 December 2027
Primary endpoints
intracranial objective response rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 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.