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Phase 4 Lung Cancer Trial, Not Yet Recruiting
NCT07674368
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 or older at the time of signing the consent form, of any gender.
- People diagnosed with advanced lung cancer (a type called non-small cell lung cancer, at a stage that cannot be removed by surgery) confirmed by a tissue or cell sample.
- People whose lung cancer has tested positive for a specific gene change called an ALK fusion.
- People who developed a side effect of high cholesterol (rated mild to moderate to moderately severe) during treatment with a drug called lorlatinib.
- People whose fasting triglyceride (a type of fat in the blood) level was at or below 5.6 mmol/L at the screening visit.
- People who are willing and able to attend all required study visits, follow the treatment plan, and complete all study procedures.
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 with a known allergy or severe allergic reaction to the study drug or to similar antibody-based medicines.
- People who have been diagnosed with an inherited condition causing very high cholesterol, known as familial hypercholesterolemia, based on the Simon Broome Criteria.
- People who have taken another type of cholesterol-lowering medication called a PCSK9 inhibitor in the 6 months before the screening visit.
- People who already had uncontrolled high cholesterol (total cholesterol above the normal range) before starting lorlatinib treatment.
- People who have been diagnosed with serious heart failure (classified as New York Heart Association Class III or IV).
- People with a prior diagnosis of cardiovascular disease caused by narrowed or blocked arteries, such as heart attack, stable heart disease, stroke, mini-stroke, or blocked arteries in the legs.
- People with a prior diagnosis of serious heart rhythm problems, such as recurrent symptomatic ventricular tachycardia or atrial fibrillation with a very fast heart rate.
- People with uncontrolled high blood pressure at the screening or start-of-treatment visit (top number at or above 160 mmHg and/or bottom number at or above 100 mmHg).
- People with a prior diagnosis of conditions that significantly affect cholesterol or fat levels in the blood, such as nephrotic syndrome, severe liver disease, or Cushing's syndrome.
- People with Type 1 diabetes, or people with Type 2 diabetes that is not well controlled (based on a blood sugar marker called HbA1c being above 8.5%).
- People with an active infection that the trial doctor considers would make participation unsafe.
- People who have taken part in another interventional clinical trial within 1 month before screening, or within a period based on the previous study drug's duration in the body — whichever is longer.
- People with a history of drug misuse, use of illegal substances, or long-term excessive alcohol use before screening.
- People who had major surgery within 3 months before screening, or who are planning major surgery during the study.
- People who have regularly used steroid medications taken throughout the body (not creams, nasal sprays, inhalers, or injections into joints) for extended periods within 3 months before screening (confirm with trial site for full details).
- People who have used weight-loss medications or had weight-loss surgery in the 2 months before screening.
- People whose blood test results at screening or the start of treatment fall outside acceptable ranges, including: kidney function below a certain level; liver enzyme levels that are too high; a muscle enzyme (creatine kinase) level that is too high; thyroid hormone levels that are too low or too high; confirmed HIV or hepatitis C infection, or active hepatitis B infection above a certain level.
- People with a positive pregnancy test.
- People who are planning to have a heart device implanted (such as a pacemaker or defibrillator) during the study period.
- People who the trial doctor considers unsuitable for injections under the skin.
- People whom the trial doctor considers unsuitable for any other reason, including poor likelihood of following the study requirements, unacceptable health risks, or factors that could affect study results.
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: 86-731-88651900
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 4
Sponsor
Hunan Cancer Hospital
Registry
ClinicalTrials.gov
Start date
10 July 2026
Est. completion
10 July 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 16
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 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.