Phase 4 Lung Cancer Trial, Not Yet Recruiting
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
Cohort 1 (Strict Cohort):
- People who have been diagnosed with advanced (stage IIIB–IV) non-small cell lung cancer, confirmed through laboratory testing of tissue or cells.
- People who are 18 years of age or older at the time of signing the consent form.
- People whose cancer has tested positive for an ALK gene change, confirmed through a tissue or blood test at the trial centre.
- People whose cancer has stopped responding to a drug called lorlatinib, who have not previously taken ensartinib, who have taken no more than two other ALK-targeting drugs, who have received no more than two rounds of chemotherapy, and who have a general health score (ECOG) of 0–2 with no significant decline in the two weeks before joining.
Cohort 2 (Compassionate Use Cohort):
- People whose cancer has stopped responding to lorlatinib.
- People with no restrictions on prior use of ensartinib or on the number of other ALK-targeting drugs or chemotherapy courses previously received.
- People who have cancer that has spread to the lining of the brain or spinal cord (leptomeningeal metastases), provided the diagnosis has been confirmed through symptoms, brain imaging, and fluid analysis from around the spine, as outlined in specific medical guidelines.
- People whose tissue sample was not taken from a tumour area that previously received radiotherapy (though new tumour growth appearing after local treatment may be acceptable — confirm with trial site).
- People with a general health score (ECOG) of 0–4.
- People whose major organ systems are functioning adequately, as assessed by the trial doctor.
- People who also meet the stage IIIB–IV non-small cell lung cancer diagnosis criterion, the age criterion (18 or older), and the ALK-positive confirmation criterion listed under Cohort 1.
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 currently have a second, separate type of cancer.
- People who have cancer that has spread to the lining of the brain or spinal cord and are unable to have a contrast-enhanced MRI scan.
- People who have had surgery within four weeks before starting the study drug, unless the procedure was minor and the trial doctor considers it not to affect participation; or people who are planned to have major surgery during the study period.
- People whose symptoms or general condition have noticeably worsened in the two weeks before screening and who are considered by the trial doctor to be unsuitable for the trial.
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.
Contact this trial
Phone: 13783590691
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Primary endpoints
Objective response rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 10 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.