Printed from Voxsanity (voxsanity.com.au) — NCT07351565 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Lung Cancer Trial, Not Yet Recruiting
NCT07351565
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 to 75 years old.
- People who have been diagnosed with non-small cell lung cancer through a tissue or cell sample (biopsy or similar test).
- People whose cancer has continued to grow or has stayed the same (not improved) after a second round of drug treatment, confirmed by imaging scans.
- People who have at least one measurable area of cancer that meets specific size requirements on CT scan, and where that area has not previously been treated with radiation or freezing therapy (confirm with trial site for full measurement details).
- People whose general physical functioning is rated 0, 1, or 2 on a standard medical scale (meaning they are fully active to somewhat limited in strenuous activity, but able to care for themselves).
- People who are expected to live for at least 6 months.
- People whose blood counts meet minimum levels — including white blood cells, platelets, and haemoglobin — without having needed a blood transfusion or blood-stimulating medication in the past 7 days (confirm with trial site for specific values).
- People whose liver function blood test results are within an acceptable range as defined by the trial (confirm with trial site for specific values).
- People whose kidneys are filtering at a sufficient rate, as calculated by a standard formula using blood test results (confirm with trial site for specific values).
- People whose blood clotting results are within an acceptable range, or — if already on blood-thinning medication — whose clotting results fall within the target range set for that medication.
- Women of childbearing age who have a negative pregnancy test (urine or blood) within 3 days before starting the trial treatment.
- People who are at risk of pregnancy and agree to use a highly effective form of contraception during the trial and for at least 180 days after stopping treatment (abstinence is acceptable if that is the person's usual practice).
- People who are willing to join the study voluntarily, have signed a written consent form before any trial procedures begin, and are able to attend follow-up appointments as required.
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 known to have an allergy to pitavastatin or to medications with a similar chemical structure.
- People known to have an allergy to pemetrexed, paclitaxel, gemcitabine, or platinum-based drugs.
- People who currently have active coughing up of blood, active diverticulitis, an abdominal abscess, or a bowel blockage that requires medical treatment.
- People who have brain or spinal fluid metastases that are causing symptoms and are not well controlled, or whose brain metastases have only been controlled for less than 2 months.
- People who have been diagnosed with another type of cancer (other than non-small cell lung cancer) within the past two years — except for certain fully treated skin cancers or completely removed early-stage cancers.
- People who have had major surgery within the 4 weeks before the trial starts, or who still have unresolved complications from a recent surgery.
- People with serious or uncontrolled health conditions, including but not limited to: uncontrollable nausea or vomiting; unrelieved bowel obstruction; difficulty swallowing medications; gut conditions that affect how drugs are absorbed; significant breathing difficulty caused by fluid around the lungs or abdomen; active HIV, hepatitis B, or hepatitis C infection; uncontrolled seizures; unstable spinal cord compression; superior vena cava syndrome; or mental health conditions that would prevent giving informed consent.
- People with a tendency to bleed or a history of blood clots, specifically including any of the following:
- A moderate bleeding event in the 3 months before screening, or a serious bleeding event in the 6 months before screening.
- Currently experiencing active bleeding, a clotting disorder, or receiving clot-dissolving or blood-thinning medication.
- A requirement for blood-thinning medications such as warfarin or heparin.
- A requirement for long-term anti-platelet medications such as aspirin or clopidogrel.
- A blood clot or stroke event (including mini-strokes and pulmonary embolism) within the past 6 months.
- People with a significant heart condition history, specifically including any of the following:
- Severe heart failure (Class III or IV on a standard medical scale).
- Unstable chest pain, newly diagnosed chest pain, or a heart attack within the past 12 months.
- An irregular heartbeat that requires medication to treat (note: people taking beta blockers or digoxin may still be considered).
- Significant heart valve disease (Grade 2 or higher on a standard medical scale).
- Blood pressure that is not well controlled (above 150/100 mmHg).
- People who have had non-infectious lung inflammation (pneumonia) requiring steroid treatment within the past year, or who currently have this condition.
- People with any past or current health conditions, treatments, or abnormal test results that could affect the trial results, prevent full participation, or lead the treating doctor to consider them 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.
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
Phone: 86+13917810850
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 1
Sponsor
Chang Chen
Registry
ClinicalTrials.gov
Start date
10 January 2026
Est. completion
30 June 2026
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
Objective response rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 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.