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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07235306
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 years or older, of any gender
- People who have been diagnosed with Stage III non-small cell lung cancer (a type of lung cancer) that cannot be removed by surgery, confirmed by a laboratory test of tissue or cell samples, with the goal of treatment being to cure the disease
- People whose lung cancer has been tested (by one of several approved lab methods) and found to have a specific genetic change called an ALK mutation
- People who are generally well enough to carry out light daily activities, as measured by a standard medical scoring system (ECOG score of 0 or 1)
- People who have completed a specific type of combined chemotherapy and radiation treatment (platinum-based chemoradiotherapy), given either at the same time or one after the other, as required by the trial
- People whose combined chemotherapy and radiation treatment was completed no more than 6 weeks before joining the trial
- People whose cancer did not grow or spread during or after their chemoradiotherapy
- People who are expected to live for more than 12 weeks
- Women who could potentially become pregnant must have had a negative pregnancy test (urine test) within 7 days before starting treatment
- People who have signed a consent form agreeing to take part, either themselves or through a legally authorised representative
- People of childbearing potential (male or female) who agree to use highly effective contraception from before entering the trial, throughout the entire study, and for 8 weeks after stopping the study treatment
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 is a mixed type containing both small cell and non-small cell lung cancer
- People who developed lung inflammation (pneumonitis) as a side effect of chemoradiotherapy that has not improved to a mild level or resolved before joining the trial
- People who still have side effects from their chemoradiotherapy that are moderate or worse in severity (Grade 2 or above on a standard medical scale)
- People with significant heart problems, including any of the following: an abnormal heart rhythm measurement on three ECG (heart tracing) tests; any important irregularities in heart rhythm or electrical activity seen on a resting ECG; conditions or medications that increase the risk of a dangerous heart rhythm problem (such as heart failure, low potassium levels, a condition called long QT syndrome, a family history of long QT syndrome, or current use of certain medications known to affect heart rhythm)
- People whose blood counts or organ function (such as liver or kidneys) are not at an adequate level
- People who have had another cancer in the past, unless it was a certain type of skin cancer that was successfully treated, a very early-stage cancer that was cured, or another solid tumour that was fully treated more than 5 years ago with no signs of return and considered low risk by their treating doctor
- People with serious or uncontrolled illnesses such as uncontrolled high blood pressure, active tendency to bleed, or active infections including hepatitis B, hepatitis C, or HIV
- People who have ongoing nausea and vomiting that cannot be controlled, a chronic digestive condition, difficulty swallowing tablets, or who have had a significant portion of their bowel removed, any of which could prevent the study drug (ensartinib) from being properly absorbed
- People who have received chemotherapy, radiation, immunotherapy, or any experimental drug treatment beyond what was given to treat their current locally advanced lung cancer
- People who have previously been treated with any ALK-targeted medicine (a type of drug called an ALK tyrosine kinase inhibitor)
- People who have had major surgery within 4 weeks before the first dose of the study drug
- People who are currently taking strong medications known to reduce the effectiveness of the study drug (strong CYP3A4 inducers) and for whom these medications cannot be stopped at least 3 weeks before starting the trial
- People who have a known allergy or sensitivity to ensartinib or any ingredient in the study drug product
- Women who are pregnant or currently breastfeeding
- People with a confirmed history of significant neurological or psychiatric conditions, including epilepsy or dementia
- People who, in the opinion of the trial doctor, have any other condition that would make participation in the trial unsuitable (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.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Registry
ClinicalTrials.gov
Start date
1 December 2025
Est. completion
31 January 2031
Primary endpoints
progressive free survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 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.