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Early Phase 1 Lung Cancer Trial, Not Yet Recruiting
NCT07458919
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.
- People with a confirmed diagnosis of locally advanced or spreading (metastatic) non-small cell lung cancer (a specific type of lung cancer) that cannot be treated with surgery or other curative treatments, as determined by the study doctor.
- People whose lung cancer has a specific gene change called an EGFR exon 19 deletion-insertion mutation, confirmed through testing of a tumour or blood sample.
- People who are largely able to care for themselves and carry out light activity, as measured by a standard medical scoring system (a score of 0 or 1 on the ECOG scale).
- People who have not previously received any systemic (whole-body) anti-cancer treatment for their locally advanced or metastatic lung cancer.
- People with a life expectancy of at least 12 months.
- People who have at least one measurable area of cancer visible on imaging scans at the start of the study.
- People who are able to swallow and keep down oral (tablet or capsule) medication.
- People whose organs (such as liver, kidneys, and bone marrow) are functioning at an adequate level.
- Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting treatment, and must agree to use a highly effective form of contraception during the study and for 3 months after the last dose.
- People who are willing and able to follow all study procedures and attend follow-up visits, and who are able to understand the trial and sign a written consent form.
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 advanced and/or symptomatic cancer that has spread to the brain or to the membranes surrounding the brain and spinal cord.
- People with active hepatitis B, or who test positive for hepatitis C antibodies, HIV antibodies, or syphilis antibodies.
- Women who could become pregnant and have a positive pregnancy test within 7 days before starting treatment, women who are pregnant or breastfeeding, or any participant (male or female) who is not using effective contraception or plans to try to conceive during treatment or within 3 months after finishing treatment.
- People who have taken certain medications within 14 days before the first dose, or who would need to continue taking them during the trial — specifically, medications known to affect heart rhythm in a particular way (QTc prolongation), or medications that strongly interact with a liver enzyme called CYP3A (confirm with trial site for specific drug names).
- People who have had major surgery or immunotherapy within the 4 weeks before the first dose, or radiation therapy within 2 weeks before the first dose.
- People whose scans show that the cancer may be growing into or very close to major blood vessels, where the study doctor believes there is a high risk of serious bleeding.
- People with a history of scarring or inflammation of the lungs (interstitial lung disease), including drug-related lung disease, any currently active lung inflammation, or signs of a condition called idiopathic pulmonary fibrosis on a baseline CT scan.
- People with other serious ongoing or unstable medical conditions that the study doctor believes could increase health risks or affect the study results, such as uncontrolled diabetes, significant mental health conditions, or notable abnormalities in blood test results.
- People whom the study doctor considers unsuitable for the trial for any other 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.
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.
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Trial details
Status
Not Yet Recruiting
Phase
Early Phase 1
Sponsor
Fuzhou General Hospital
Registry
ClinicalTrials.gov
Start date
30 March 2026
Est. completion
30 October 2030
Primary endpoints
PFS
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 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.