Printed from Voxsanity (voxsanity.com.au) — NCT07510594 — 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
NCT07510594
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 whose cancer has been confirmed by laboratory testing of tissue or cells as metastatic Large Cell Neuroendocrine Carcinoma (LCNEC) or a type of high-grade neuroendocrine cancer called EP-NEC.
- People who have not yet received any systemic (whole-body) treatment for advanced or metastatic disease; those who had earlier chemotherapy or radiotherapy for non-metastatic disease must have finished that treatment at least 6 months before being diagnosed with metastatic disease.
- People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1); tumours previously treated with radiotherapy may only count if they have clearly grown since that treatment and are not the only tumour present.
- People aged 18 to 75 years.
- People who are generally able to carry out daily activities with no or minimal limitations (ECOG performance status 0 or 1).
- People whose life expectancy is at least 3 months.
- People whose blood counts fall within acceptable ranges, without having needed a blood transfusion or blood-stimulating medicines in the past 14 days (specific thresholds for neutrophils, platelets, and white blood cells apply — confirm with trial site).
- People whose liver enzyme levels, bilirubin, and kidney function results fall within acceptable ranges (specific thresholds apply, with some allowances for liver metastases or a specific liver condition called Gilbert's syndrome — confirm with trial site).
- People whose blood clotting function test results fall within acceptable ranges (confirm with trial site).
- People whose heart pumping function (left ventricular ejection fraction) is at least 50%, as measured by ultrasound.
- People of childbearing potential who agree to use reliable contraception during the study and for 6 months after the last dose; women must have a negative pregnancy blood test within 7 days before joining and must not be breastfeeding.
- People who are willing to take part voluntarily, sign a consent form, follow the study requirements, and attend follow-up visits.
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 active brain metastases or cancer spread to the membranes around the brain, unless their condition has been stable for at least 2 weeks after treatment, with no new or growing lesions on imaging, and they have been off steroids or anti-seizure medicines for at least 14 days (additional conditions apply — confirm with trial site).
- People who have previously been treated with certain anti-cancer drugs that target blood vessel growth (such as Anlotinib, Apatinib, or Bevacizumab) or immune checkpoint drugs targeting PD-1 or PD-L1.
- People who have had another cancer within the past 5 years, except for certain cured early-stage cancers such as cervical carcinoma in situ or basal cell skin cancer.
- People who have difficulty swallowing or absorbing oral medicines, for example due to previous stomach or bowel surgery, chronic diarrhoea, or bowel obstruction.
- People with fluid build-up around the lungs, heart, or abdomen that is not controlled and requires repeated draining.
- People with spinal cord compression that has not been successfully treated or has not been clinically stable for at least 1 week before joining.
- People whose imaging (CT or MRI) shows the tumour is growing into or is very close to large blood vessels.
- People where the treating doctor judges there is a high risk of the tumour invading major blood vessels and causing serious bleeding during the study.
- People with a history of serious bleeding problems, including coughing up more than one tablespoon of blood per day in the 3 months before joining, or any other significant bleeding (such as stomach or bowel bleeding, stomach ulcers, open wounds, or unhealed fractures) within 4 weeks before joining.
- People who still have unresolved side effects from previous cancer treatment that are worse than mild (above Grade 1), except for hair loss.
- People who have had major surgery, a surgical biopsy, or a significant injury within 28 days before joining.
- People who have had a blood clot event — such as a stroke, transient ischaemic attack (mini-stroke), deep vein thrombosis, or pulmonary embolism — within the 6 months before joining.
- People who have an active autoimmune disease that required ongoing systemic treatment within the past 2 years.
- People who have received a live or weakened (attenuated) vaccine within 28 days before the first dose.
- People who have had a severe allergic reaction to another monoclonal antibody medicine.
- People with a history of substance abuse involving psychotropic drugs that cannot be stopped, or those with a mental health disorder (confirm with trial site).
- People with poorly controlled high blood pressure (systolic at or above 150 mmHg or diastolic at or above 100 mmHg).
- People with moderate or severe heart problems, including certain types of heart rhythm issues, significant heart disease, or heart failure of a certain severity (NYHA Class II–IV).
- People with an active or uncontrolled serious infection.
- People with liver cirrhosis or active hepatitis B or C infection based on specific blood test results.
- People who are HIV positive.
- People with poorly controlled diabetes (fasting blood sugar above 10 mmol/L).
- People with significant protein in the urine confirmed by a 24-hour urine test showing more than 1.0 g of protein.
- People who have taken part in another clinical trial within the 28 days before joining.
- People who, in the treating doctor's judgement, have any other condition that makes participation unsafe or 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.
Contact this trial
Phone: 008618526812877
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
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
31 December 2026
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective Response Rate (ORR) (per RECIST Version 1.1)
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.