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Phase 4 Lung Cancer Trial, Not Yet Recruiting
NCT06483009
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 aged 18 to 75 years old.
- People who have been diagnosed with a specific type of lung cancer (non-squamous non-small cell lung cancer, or NSCLC) that is locally advanced, has spread to other parts of the body, or has come back, at a stage confirmed by laboratory testing of tissue or cell samples, where surgery and combined radiation-chemotherapy treatment are not suitable options, and who have not yet received systemic treatment.
- People whose main lung tumour is smaller than 5cm across and is in a relatively separate area, away from major blood vessels and important structures.
- People whose tumour has been confirmed by tissue testing to not have certain genetic changes (specifically, no EGFR sensitising mutations and no ALK gene fusions).
- People who have at least one tumour that can be measured using standard imaging criteria (RECIST 1.1), including tumours in previously treated areas if there is confirmed evidence of growth.
- People who have not previously had systemic treatment for advanced or metastatic disease; those who have previously had platinum-based chemotherapy before or after surgery, or combined radiation-chemotherapy for advanced disease, may be considered if the cancer progressed or returned at least 6 months after finishing that chemotherapy.
- People with brain metastases that are either causing no symptoms or have stable symptoms, provided certain conditions are met: there is at least one measurable tumour outside the brain; brain symptoms are either absent or have been stable for at least 2 weeks; and no steroid medication is needed, or steroid treatment was stopped within 7 days before the first study drug dose, or the steroid dose has been stable at a low level (no more than 10mg per day of prednisone or equivalent) for at least 7 days before the first dose.
- People with a general health and activity level rated at 0 or 1 on a standard scale used in cancer trials (ECOG scale), meaning they are fully active or have minor restrictions but are able to carry out light activity.
- People with an expected survival of more than 3 months.
- People whose blood test results show adequate organ function, including a white blood cell count (specifically neutrophils) of at least 1.5×10⁹/L without the use of growth-stimulating injections in the past 14 days, and a platelet count of at least 100×10⁹/L without a blood transfusion in the past 14 days.
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 has been confirmed as small cell lung cancer (SCLC), including mixed types containing both small cell and non-small cell lung cancer.
- People who have been diagnosed with another type of cancer within the 5 years before joining the trial (except for certain fully treated skin cancers or early-stage non-invasive cancers).
- People who have previously been treated with certain immunotherapy drugs that target PD-1, PD-L1, PD-L2, or similar immune system pathways (such as CTLA-4, OX-40, or CD137 targeting drugs).
- People who have an active autoimmune disease that has required ongoing systemic medical treatment within the 2 years before joining the trial (note: replacement therapies such as thyroid hormone, insulin, or low-level steroid replacement for gland problems are not considered systemic treatment in this context).
- People who are pregnant or breastfeeding.
- People who have a severe or uncontrolled illness affecting the whole body.
- People who have any medical history, condition, ongoing treatment, or abnormal test results that could affect the study results or make it difficult to participate throughout the trial, or who are considered unsuitable by the trial doctor for any other reason that poses a risk (confirm with trial site).
- People whose lung cancer has spread diffusely throughout both lungs in a way that ablation therapy (a procedure to destroy tumour tissue) would not be able to help.
- People with widespread cancer spread to the lining around the lungs, causing large amounts of fluid build-up.
- People for whom a needle procedure to the tumour would be too difficult or unsafe due to the tumour being too close to major blood vessels in the chest, or where a safe needle path cannot be identified, or due to allergy to contrast dye used in imaging, or because the person is unable to cooperate with the procedure.
- People with severely reduced lung function, where the maximum breathing capacity is less than 40% of the expected level.
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.
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.
Contact this trial
Phone: 18017321320
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 4
Sponsor
Shanghai Chest Hospital
Registry
ClinicalTrials.gov
Start date
1 October 2024
Est. completion
1 October 2027
Primary endpoints
Progression-free survival (PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 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.