Printed from Voxsanity (voxsanity.com.au) — NCT07141771 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Lung Cancer
Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07141771
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 who are able to fully understand and sign a consent form agreeing to the trial's requirements, or who have a legally authorised representative who can sign on their behalf.
- People who are 18 years of age or older.
- People who have been diagnosed with stage IV small cell lung cancer that has spread to other parts of the body (confirmed by a tissue or cell sample), is not suitable for surgery or radiotherapy aimed at curing the disease, and has continued to grow or spread after first-line treatment with a platinum-based chemotherapy regimen.
- People whose general physical fitness is rated 0 or 1 on the ECOG/WHO scale, meaning they are either fully active or able to carry out light activity (confirm with trial site).
- People whose doctors expect them to survive for at least 12 weeks.
- People who have agreed to have a tissue biopsy taken, and from whom enough tissue can be obtained for specialised genetic and protein testing.
- People whose major organs are functioning well enough during the screening period, without having needed a blood transfusion, blood-stimulating medicines, or albumin preparations in the 14 days before screening — including:
- Adequate blood cell counts (sufficient white blood cells, platelets, and haemoglobin levels).
- Adequate liver function, with specific limits depending on whether liver metastases or a condition called Gilbert syndrome are present.
- Adequate kidney function, based on a calculated measure of how well the kidneys filter waste.
- Adequate blood clotting function, within acceptable ranges (or within treatment range for people already on blood thinners).
- Heart pumping function of greater than 50% as measured by an ultrasound of the heart.
- People who test negative on a blood pregnancy test within 7 days before the first dose of the trial drug, and who agree to use reliable contraception (hormonal methods, barrier methods, or abstinence) during the trial and for at least 6 months after the last dose — this applies to people who are biologically capable of having children.
- People whose tumour tissue has been tested and classified according to a specific molecular subtype system (SCLC-A, N, P, or I), based on protein marker testing including markers such as TTF-1, VIM, AXL, and others (confirm with trial site for full details).
- People who have at least one tumour that can be measured according to standard imaging criteria (RECIST 1.1).
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 still have significant side effects from previous cancer treatment that have not returned to a mild level (grade 1 or lower) or back to their pre-treatment baseline within 4 weeks before the first dose — not counting hair loss or tiredness.
- People who cannot stop taking certain medicines or herbal supplements in the 3 weeks before and during the study, specifically: (1) strong activators or blockers of a liver enzyme called CYP3A4, or (2) medicines that are mainly broken down by that enzyme.
- People who do not agree to a second biopsy, or from whom enough tissue cannot be obtained for the required genetic and protein testing.
- People with a significantly prolonged heart electrical signal (QTc interval greater than 470 ms on a heart tracing, measured three times), or other clinically significant heart rhythm or electrical conduction problems, or factors that raise the risk of dangerous heart rhythms — such as heart failure, low potassium, inherited long QT syndrome, a close family member who died suddenly before age 40, or current use of medicines known to affect heart rhythm.
- People with active hepatitis B infection, defined by specific blood test results showing the virus is active.
- People with active hepatitis C infection, or who test positive for hepatitis C antibodies with detectable virus levels in the blood.
- People with brain metastases that are currently active — however, people may be considered if their brain metastases are limited to certain areas of the brain, have been adequately treated with surgery or radiotherapy, have been stable on scans for at least 4 weeks, and do not need steroid medicines to manage symptoms.
- People with ongoing medical conditions that are not well controlled, including:
- A serious infection in the 4 weeks before starting treatment, such as one requiring hospitalisation, a bloodstream infection, or severe pneumonia — or use of antibiotic treatment (not preventive antibiotics) in the 2 weeks before starting treatment.
- Symptomatic heart failure (moderate to severe) or poorly controlled irregular heartbeat.
- Another cancer diagnosed within the past 5 years (with some exceptions for certain skin cancers, or early-stage breast or cervical cancer that was fully treated with no signs of return).
- Suspected or confirmed acute promyelocytic leukaemia.
- Cancer that has spread to the lining of the brain or is compressing the spinal cord.
- Poorly controlled high blood pressure or diabetes.
- Symptomatic lung disease originating from within the lungs.
- A blood clot or blockage in an artery within the past 6 months, such as a heart attack, unstable chest pain, stroke, or mini-stroke.
- Significant malnutrition requiring intravenous nutrition (though people who have been stable for more than 4 weeks after correction of malnutrition may be considered).
- Cancer that has grown into major nearby structures such as large blood vessels, the windpipe, or the food pipe, or is at risk of causing a connection to form between these structures.
- Previous placement of a stent in the food pipe or windpipe.
- Other serious medical conditions or abnormal test results that the investigator determines make participation unsafe or would interfere with the study results.
- A history of a hole or abnormal opening in the gut (perforation or fistula) within the 6 months before joining.
- Fluid build-up in spaces such as around the lungs, in the abdomen, or around the heart that cannot be controlled and requires repeated drainage (people who do not need drainage or whose fluid has not significantly increased over 3 days may be considered).
- People with active gut or other digestive conditions, or who have had surgery, that may significantly affect how the body absorbs, processes, or removes medicines — including conditions such as malabsorption syndrome, inflammatory bowel disease, bowel obstruction, or removal of part of the stomach or small intestine.
- People with a history of serious underlying lung disease, such as moderate to severe COPD, interstitial lung disease, drug-related lung disease, active or chronic infectious pneumonia, or a previous lung transplant.
- People who are pregnant or breastfeeding.
- People who are currently taking part in another interventional clinical trial and have not yet completed that trial's treatment.
- People who have a history of having received a donated organ transplant or donated stem cell transplant.
- People who have had major surgery (such as surgery on the brain, chest, or abdomen, or major blood vessel procedures) within 4 weeks before the first dose of the trial drug, or who have a wound, ulcer, or fracture that has not yet healed — note that minor local surgery for symptom relief may be acceptable.
- People who are HIV-positive (testing positive for HIV 1 or 2 antibodies).
- People with a known active syphilis infection or active tuberculosis.
- People with a diagnosed mental health condition for which they are receiving medication.
- People with a history of drug abuse or illicit drug use.
- People whom the investigator considers unsuitable for the trial for any other reason, including physical conditions, previous or current treatments, abnormal test results, or unwillingness to follow the study's procedures and requirements.
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Registry
ClinicalTrials.gov
Start date
31 December 2025
Est. completion
30 June 2030
Primary endpoints
ORR
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 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.