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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07413952
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 are willing to take part and have signed a written consent form agreeing to participate in the study.
- People aged 18 to 75 years who have been diagnosed with advanced non-small cell lung cancer (a type of lung cancer) confirmed by laboratory testing of tissue or cell samples, and classified as stage IV.
- People whose tissue or cell test reports — issued by an accredited hospital or testing facility — confirm a specific type of gene change in the cancer called an EGFR classical mutation (either 19Del or 21L858R).
- People whose general health and ability to carry out daily activities is rated as 0 or 1 on a standard medical scale (meaning generally active or restricted in strenuous activity only), and who are expected to survive for at least 3 months.
- People who have cancer that has spread to the brain (either to the brain tissue or the lining around it), confirmed by CT or MRI scan, with or without symptoms.
- People who have at least one tumour that can be measured using standard imaging criteria (called RECIST 1.1).
- People who have 3 or more tumours in the brain, with at least one tumour measuring 2 cm or larger, and who have not previously received any systemic cancer treatment (such as chemotherapy, targeted therapy, immunotherapy, or experimental drugs) for their advanced or metastatic lung cancer — though people who received earlier preventive or post-surgery treatments are eligible if their cancer did not return within 6 months of finishing that treatment, and people who received local treatments such as radiotherapy to areas that are not being measured in this trial are also eligible.
- People whose blood and organ function test results meet all of the following levels: white blood cell count (ANC) at or above 1.5×10⁹/L; platelet count at or above 100×10⁹/L; haemoglobin at or above 90 g/L; total bilirubin at or below 1.5 times the normal upper limit (or up to 3 times for people with liver involvement); liver enzymes AST and ALT at or below 2.5 times the normal upper limit (or up to 5 times for people with liver involvement); and kidney function markers within acceptable ranges.
- People who are able to use highly effective contraception throughout the study and for 12 months after stopping treatment — this applies to male participants with the ability to father children and female participants who could become pregnant.
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 cannot be confirmed through tissue or cell sample testing.
- People who are expected to need other systemic cancer treatments outside of this trial during the study period.
- People who have been diagnosed with another cancer in the past 2 years, unless it was a well-controlled skin cancer (basal cell type), early-stage cervical cancer, or early-stage breast cancer that had not spread.
- People who have significant stomach or bowel conditions that may affect how a tablet is swallowed or absorbed, such as peptic ulcers or inflammatory bowel disease.
- People who have a known or suspected allergy or sensitivity to the study drug (lielitinib), radiotherapy, or any components used in the study treatments.
- People who have previously been treated with a type of targeted therapy that blocks a protein called EGFR (known as EGFR tyrosine kinase inhibitors or EGFR-TKIs).
- People who have taken certain medications that strongly affect how the body processes drugs (called strong CYP3A4 inhibitors or inducers) in the 7 days before starting the study drug, or who are expected to need these medications long-term during the trial; also people who have used traditional Chinese medicines or preparations with anti-cancer effects in the 2 weeks before starting the study drug, or who are expected to need them during the trial.
- People who have a history of scarring or inflammation of the lung tissue (interstitial lung disease), lung damage caused by medication, or lung inflammation from radiotherapy that required steroid treatment; also people who have worsening or active lung symptoms at the start of the study, or who the investigator considers to be at high risk for this type of lung condition.
- People who have serious heart rhythm problems (such as a QT interval above 470 ms on a heart tracing) or heart failure (with the heart pumping at less than 50% of normal capacity).
- People who are pregnant or currently breastfeeding.
- People who are currently taking part in another clinical trial or who have done so in the past 4 weeks.
- People who have serious ongoing or active physical or mental health conditions that, in the investigator's judgement, could increase the risks of being in the study or make the results harder to interpret.
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: Jiexia Zhang, Prof., The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong
Phone: +8613903056432
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
The First Affiliated Hospital of Guangzhou Medical University
Registry
ClinicalTrials.gov
Start date
1 April 2026
Est. completion
31 December 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Intracranial progression-free survival (iPFS)
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.