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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07009925
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 give written consent before any trial procedures begin.
- People aged 18 or older.
- People who have been diagnosed through a tissue or cell sample with a specific type of advanced or returning lung cancer called squamous non-small cell lung cancer (NSCLC) that has spread (stage IV), cannot be removed by surgery, is not suitable for a combined radiation and chemotherapy treatment aimed at cure, and who have not yet received any systemic (whole-body) treatment for this cancer. Mixed tumour types (such as adenosquamous) are allowed if a squamous component is present in the sample. A specific test called a PD-L1 test must be done before joining.
- People who have at least one tumour that can be measured using standard imaging criteria (RECIST version 1.1).
- People who have not had any previous whole-body anti-cancer treatment for their advanced or metastatic disease. People who previously received platinum-based chemotherapy before or after surgery, or combined radiation and chemotherapy for advanced disease, may still be considered if at least 6 months have passed since that treatment ended and the cancer returned or progressed.
- People with a performance status score of 0 or 1 on the ECOG scale, meaning they are either fully active or have some limits on strenuous activity but can carry out light work (confirm with trial site).
- People with an expected survival of more than 3 months.
- People whose blood cell counts fall within required levels — including white blood cells, neutrophils, platelets, and haemoglobin — assessed without the use of blood transfusions, blood products, or certain growth-stimulating drugs in the 7 days before the test. If a blood transfusion was received during the screening period, blood counts must be re-checked after at least 1 week and still meet the required levels.
- People whose liver and kidney function blood test results are within the required ranges, including total bilirubin, liver enzymes (AST, ALT, ALP), and kidney function markers (creatinine and creatinine clearance), with adjusted ranges allowed for people who have cancer spread to the liver or bones.
- People with normal blood clotting function, based on specific lab measurements (INR or prothrombin time) within the required range.
- People with thyroid hormone levels within the normal range, or whose main thyroid hormones (T3/FT3 and FT4) are normal even if one related measure (TSH) is slightly outside the normal range.
- People with heart enzyme (myocardial zymogram) results within the normal range, though minor abnormalities may be allowed if the investigator considers them not clinically significant (confirm with trial site).
- Women of childbearing age who have a negative pregnancy test (urine or blood) within 3 days before the first dose of the study drug.
- All people who could potentially conceive — whether male or female — who are willing to use contraception throughout the treatment period and for 180 days after the last dose of the study drug.
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 are currently receiving treatment as part of another interventional clinical trial.
- People whose lung cancer is confirmed to be a non-squamous type. If small cell elements are present in the tumour, the person would not be eligible.
- People who have previously received immunotherapy treatments, such as checkpoint inhibitors (e.g. anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies), immune-stimulating drugs, immune cell therapies, or any other treatment that works by targeting the immune system's response to tumours.
- People with a known allergy or serious sensitivity to any of the study drugs or their ingredients.
- People with a history of severe bleeding or blood clotting disorders; or who have had significant bleeding events (such as coughing up blood, gastrointestinal bleeding, or nosebleeds beyond minor ones) in the month before the first dose; or whose scans during screening show the tumour is near major blood vessels or has significant breakdown, which the investigator determines poses a bleeding risk.
- People whose tumour has grown into nearby vital organs or blood vessels (such as the aorta, heart, windpipe, or oesophagus), or where there is a risk of an abnormal connection forming between the oesophagus and airway or chest cavity.
- People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires draining more than once per month.
- People with brain metastases causing symptoms, cancer spread to the membranes around the brain, or compression of the spinal cord.
- People with a history of, or current, non-infectious lung inflammation (pneumonitis or interstitial lung disease) that has required treatment with steroid medications.
- People with serious other health conditions, including a history of severe lung or heart disease, or certain blood clot or circulation events (such as heart attack, unstable chest pain, stroke, or a brief stroke-like episode) within the 6 months before treatment; or a serious blood clot in a deep vein or the lungs within the 3 months before enrolment.
- People with a history of autoimmune diseases (conditions where the immune system attacks the body), such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, and others. However, people with autoimmune-related underactive thyroid who are on a stable thyroid hormone dose, or people with well-controlled type 1 diabetes on a stable insulin dose, may still be considered.
- People with active ongoing infections, including tuberculosis, active hepatitis B (with specific virus levels above a set threshold), hepatitis C, or HIV.
- People with a known mental health condition or substance use issue that may affect their ability to follow the trial requirements.
- People with any other medical history, condition, treatment, or abnormal test result that the investigator believes could interfere with the trial results or make participation not in the person's best interest.
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: +8613809029766
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Jiangsu Cancer Institute & Hospital
Registry
ClinicalTrials.gov
Start date
1 June 2025
Est. completion
1 May 2027
Primary endpoints
progression-free survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 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.