Printed from Voxsanity (voxsanity.com.au) — NCT07083687 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07083687
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 who have been formally diagnosed (through tissue or cell testing) with a type of non-small cell lung cancer (NSCLC) that has a specific genetic change called ROS1+, and who also have cancer that has spread to the brain, confirmed before starting the drug lorlatinib.
- People whose cancer has tested positive for the ROS1 gene rearrangement, confirmed by one of several accepted laboratory methods; people whose cancer also shows other treatable gene changes (besides ROS1) will need to be reviewed by the study experts to determine whether they may be eligible (confirm with trial site).
- People who have either had no prior systemic cancer treatment, or have had one prior treatment using platinum-based chemotherapy.
- People whose brain metastases have been confirmed by MRI or CT scan and have not yet been treated, prior to starting lorlatinib.
- People whose brain metastases are not causing symptoms, or who do not currently need steroid medication for them, or who are on a stable or reducing dose of 10 mg or less per day of prednisone (or an equivalent steroid).
- People who have at least one measurable brain lesion that is 5 mm or longer at its widest point, as assessed by standard imaging guidelines (RECIST 1.1).
- People with a general health and activity level rated 0 or 1 on a standard medical scale (ECOG), meaning they are fully active or able to carry out light activity.
- People whose expected survival is 12 weeks or longer.
- People whose blood, liver, kidney, clotting, and pancreas function results fall within the acceptable ranges required by the trial, specifically:
- Blood counts are adequate — including haemoglobin, white blood cells, and platelets — without having needed blood transfusions or certain blood-boosting medications in the past 14 days.
- Liver function blood test results are within acceptable limits (with slightly higher limits allowed if the cancer has spread to the liver).
- Kidney function is adequate, based on a blood test or estimated kidney clearance rate.
- Blood clotting test results are within acceptable limits (with adjustment allowed for people already on blood-thinning medication).
- Pancreas enzyme levels are within acceptable limits.
- Women who could potentially become pregnant must have a negative pregnancy blood test taken within 7 days before the first dose of the trial drug; all participants, regardless of gender, must agree to use contraception throughout the entire treatment period and for at least 90 days after the last dose.
- People who understand the trial, are willing to sign a consent form, are able to follow the treatment and visit schedule, and can cooperate with monitoring of side effects and treatment response.
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 already been treated with this trial's investigational drug, or who are known to be allergic to any of its ingredients.
- People who are currently taking part in another interventional clinical trial (observational studies or later stages of interventional studies may be acceptable — confirm with trial site).
- People whose cancer has spread to both the brain and the thin membranes surrounding the brain and spinal cord (leptomeningeal metastases).
- People whose brain metastases involve bleeding, or whose nervous system complications require urgent treatment such as surgery or radiation therapy.
- People with spinal cord compression, unless their pain and neurological function have been stable or improving for at least 2 weeks before joining the trial.
- People who have had major surgery (other than a biopsy) within 14 days before joining the trial.
- People who have previously received radiation therapy to the brain.
- People who have had a fever above 38°C in the past week, or who have a clinically significant infection (such as active HIV, active hepatitis C, active hepatitis B, active tuberculosis, or serious infections requiring hospitalisation).
- People who have significant heart rhythm or electrical abnormalities on a resting ECG, including a prolonged QT interval (450 ms or more in males, 470 ms or more in females), complete left bundle branch block, second-degree or higher heart block, significant irregular heartbeat, or atrial fibrillation.
- People who currently have, or have had in the past 3 months, unstable chest pain (angina), serious heart failure, a heart attack, heart bypass surgery, a stroke, an untreated mini-stroke (TIA), or a symptomatic blood clot in the lungs.
- People who have risk factors for abnormal heart rhythms, such as significantly low potassium levels with symptoms requiring treatment, a personal or family history of a condition called long QT syndrome.
- People with active or past clinically significant interstitial lung disease, lung fibrosis, or active tuberculosis.
- People with difficulty swallowing, active gastrointestinal disease, or other conditions that would significantly affect how the trial drug is absorbed or processed by the body, including a history of major stomach removal surgery.
- People with other immune system deficiency conditions (acquired or present from birth), or who have previously had a solid organ or stem cell transplant.
- People with severe or uncontrolled serious illnesses, such as significant mental health or neurological conditions (including epilepsy or dementia), unstable respiratory, heart, liver, or kidney disease, or high blood pressure that remains at a severe level despite medication.
- People who have been diagnosed with or treated for another cancer within the past 5 years (with exceptions for certain fully treated skin cancers, bladder carcinoma in situ, cervical carcinoma in situ, ductal carcinoma in situ, or localised prostate cancer).
- People who have used medications known to prolong the QT interval within 2 weeks before the first dose.
- People who have used certain medications or foods known to strongly affect the way the body processes drugs (specifically strong CYP3A4 inhibitors, inducers, or certain substrates with a narrow safety range) within the 2 weeks before the first dose.
- People with severe acute or chronic mental illness, including recent (within the past year) or active thoughts or behaviours related to suicide.
- Pregnant or breastfeeding women, or people with the potential to have children who are unwilling to use effective contraception during treatment and for 90 days after the last dose.
- People whom the trial investigators believe may be unable to complete the study or follow its requirements.
- People whom the trial investigators believe may face other risks that make participation unsuitable.
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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Kids Helpline — 24/7, free and private for anyone aged 5 to 25: 1800 55 1800
- headspace — mental health support for 12 to 25 year olds: headspace.org.au
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: 13170419973
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
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Hunan Cancer Hospital
Registry
ClinicalTrials.gov
Start date
15 August 2025
Est. completion
1 January 2027
Primary endpoints
Intracranial Objective Response Rate (iORR), based on the modified version 1.1 of the Response Evaluation Criteria in Solid Tumors (RECIST)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.