Printed from Voxsanity (voxsanity.com.au) — NCT07547332 — 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
NCT07547332
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 have signed a written consent form, are aged 18 to 75 years, and are generally able to carry out daily activities with little or no limitation (as measured by a standard medical scoring tool called ECOG, with a score of 0 or 1).
- People who have been diagnosed with extensive-stage small cell lung cancer (ES-SCLC) confirmed by a tissue or cell sample, staged using a recognised medical staging system.
- People with ES-SCLC who have already received at least one previous round of treatment for their cancer.
- People who previously had brain metastases (cancer that spread to the brain) that have been treated and are no longer causing symptoms, provided all of the following apply: the affected areas are only in the upper parts of the brain or the cerebellum (not the brainstem or spinal cord); no ongoing steroid medication is needed to manage the brain disease; no targeted brain radiation was given within 7 days before joining the trial; and no signs of the brain disease getting worse have been seen on scans since treatment ended. If new symptom-free brain metastases are found during screening scans, the person must first receive radiation and/or surgery for those areas — after that treatment, joining the trial may be possible without needing further brain scans, if all other criteria are met (confirm with trial site).
- People who have at least one measurable area of disease visible on scans, according to a standard measurement system called RECIST v1.1; a previously treated area may only count if there is clear evidence it has grown back and it is not the only site of disease.
- People whose blood counts and organ function meet specific levels on tests done within 14 days before joining, including: sufficient white blood cells, lymphocytes, platelets, and haemoglobin; blood clotting results within acceptable ranges (for those not on blood thinners; those on blood thinners must be on a stable dose); liver enzyme levels within acceptable ranges (with slightly higher limits allowed for people with confirmed liver or bone metastases); bilirubin levels within acceptable range (a higher limit is allowed for people with a condition called Gilbert's disease); and kidney function within an acceptable range.
- People who are able to provide a tumour tissue sample before treatment begins (this can be submitted after enrolling in the trial).
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 active or untreated cancer that has spread to the brain, as seen on CT or MRI scans during screening or on previous imaging.
- People who have spinal cord compression that has not been fully treated with surgery and/or radiation, or who have a history of spinal cord compression without clear evidence of stable disease for at least one week before joining.
- People whose cancer has spread to the thin layers of tissue surrounding the brain and spinal cord (leptomeningeal metastases).
- People with uncontrolled fluid build-up around the lungs, heart, or in the abdomen that requires draining once a month or more often; indwelling drainage tubes are not permitted.
- People with uncontrolled or symptomatic high calcium levels in the blood above specified limits.
- People who have had another type of cancer in the past 5 years, except for certain low-risk cancers that have been fully treated and have a very high survival rate (such as some skin cancers, early-stage cervical changes, localised prostate cancer treated with surgery, or certain breast duct conditions treated with surgery).
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
- People who have had a severe allergic or anaphylactic reaction to certain types of laboratory-made antibody-based medicines in the past.
- People with a known allergy to any component of biological medicines made using a specific type of laboratory cell, or to the ingredients in the study drug (confirm with trial site).
- People with a history of autoimmune diseases (conditions where the immune system attacks the body), including conditions such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, myasthenia gravis, autoimmune hepatitis, Sjögren's syndrome, Guillain-Barré syndrome, vasculitis, and others — noting that people with autoimmune thyroid disease on a stable thyroid hormone dose, or type 1 diabetes on a stable insulin dose, may still be considered. People with certain skin conditions (eczema, psoriasis, lichen simplex chronicus, or vitiligo — but not psoriatic arthritis) may also be considered if the rash covers less than 10% of the body, is well controlled with mild topical creams, and has not flared in the past 12 months without needing stronger treatments.
- People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, or unexplained pneumonia, or who have signs of active lung inflammation on a chest CT scan taken during screening.
- People with severe interstitial lung disease (scarring or inflammation of the lungs).
- People who test positive for HIV.
- People with active hepatitis B or hepatitis C infection — noting that people with a past (resolved) hepatitis B infection may still be considered if specific blood tests are performed before joining, and people who have had hepatitis C may be considered if a specific test confirms the virus is no longer present in the blood.
- People with active tuberculosis.
- People with a serious active infection at the time of enrolment, such as one requiring hospitalisation, a bloodstream infection, or severe pneumonia.
- People with serious heart conditions, such as moderate-to-severe heart failure (NYHA Class II or higher), a heart attack within the past 3 months, unstable abnormal heart rhythms, or unstable chest pain due to heart disease. People with known coronary artery disease, certain other heart conditions, or reduced heart pumping function must be on the best possible stable treatment as determined by their doctor, including specialist heart care if needed.
- People who have had major surgery within 28 days before joining (not including diagnostic procedures), or who are expected to need major surgery during the study.
- People who have previously received a bone marrow transplant from a donor or a solid organ transplant.
- People with any other significant illness, abnormal test result, or physical finding that, in the investigator's judgement, would make the study drug unsafe for them, make results harder to interpret, or put them at high risk of serious side effects.
- People who have previously received anti-cancer treatment for ES-SCLC, or who have taken part in another clinical drug trial or received another experimental treatment within 28 days before joining.
- People who have received a live vaccine within 4 weeks before joining, or who are expected to need one during the study.
- People who have previously been treated with certain types of immune-based cancer therapies, including anti-PD-1 or anti-PD-L1 antibodies, CD137 activating agents, or other immune checkpoint treatments.
- People who have taken systemic (whole-body) immune-suppressing medicines within 2 weeks before joining, such as prednisone, cyclophosphamide, methotrexate, thalidomide, or anti-TNF medicines — noting that short-term, low-dose use (such as a single dose for nausea) may be acceptable after review and approval by the investigator and medical monitor; and that inhaled steroids for lung disease, certain blood pressure-related steroids, and low-dose steroid replacement for adrenal insufficiency are permitted.
- People with a known allergy to platinum-based medicines or etoposide (chemotherapy drugs).
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: +8615221538837
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
Shanghai Pulmonary Hospital, Shanghai, China
Registry
ClinicalTrials.gov
Start date
6 April 2026
Est. completion
1 January 2028
Primary endpoints
Progression-Free Survival (PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 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.