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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT06851169
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 willing to take part voluntarily, have signed a consent form, and are able to attend follow-up appointments as required
- People aged between 18 and 75 years old at the time of signing the consent form, of any gender
- People with a physical fitness score of 0 or 1 on the ECOG scale, which means they are fully active or have only minor limits on strenuous activity (confirm with trial site)
- People who have been confirmed through tissue testing to have non-small cell lung cancer (NSCLC), with enough tissue sample available
- People with NSCLC that has been staged as resectable (meaning it may be removable by surgery) Stage II to IIIB (with Stage IIIB limited to a specific sub-group), based on the AJCC 9th edition staging system (confirm with trial site)
- People whose cancer cells show a PD-L1 expression level of 50% or higher, as measured by laboratory testing
- People whose expected survival is at least 12 weeks
- People who have not previously had radiotherapy, chemotherapy, surgery, or targeted therapy for their cancer before joining the trial
- People who have at least one measurable tumour lesion as defined by the RECIST 1.1 measurement system (confirm with trial site)
- People of reproductive age — both male and female — who agree to use reliable contraception before entering the trial, throughout the study, and for up to 8 weeks after stopping the study drug
- People who agree to provide tumour tissue samples for use in research related to this study
- People who agree to undergo surgery aimed at completely removing the tumour
- People who are assessed by specialist doctors as having no medical reasons preventing surgery
- People who have sufficient lung function to undergo the planned lung removal surgery
- People whose lung function testing shows a breathing capacity (FEV1) of at least 1.5 litres, or where the expected breathing capacity after the planned surgery is at least 800 mL
- People whose blood count results meet all of the following: haemoglobin at least 90 g/L; neutrophil count at least 1.5 × 10⁹/L; platelet count at least 80 × 10⁹/L — without having had blood transfusions or certain blood-stimulating medications in the past 14 days
- People whose liver and kidney function blood test results fall within acceptable ranges, specifically: total bilirubin no more than 1.5 times the upper limit of normal; liver enzymes (ALT and AST) no more than 2.5 times the upper limit of normal; and kidney function (creatinine or creatinine clearance) within acceptable limits (confirm with trial site)
- People whose blood clotting test results are within acceptable ranges, or — if already on stable anticoagulant (blood-thinning) treatment for at least two weeks — whose clotting results fall within locally accepted treatment limits (confirm with trial site)
- Women of childbearing age (defined here as ages 15–49) who have a negative urine pregnancy test taken within 7 days before starting treatment
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 whose lung cancer includes large cell carcinoma, mixed cell lung cancer, or small cell lung cancer components
- People whose scans show the tumour is very close to major blood vessels (less than 5 mm away), or where a centrally located tumour is 2 cm or less from the main airway, or where the tumour shows significant hollowing out or tissue breakdown
- People who have already received any systemic cancer treatment for NSCLC, including chemotherapy, immunotherapy, or experimental treatments
- People who have previously received radiotherapy directed at the lung cancer
- People who have had a different cancer (other than NSCLC) in the five years before joining this study — though some early-stage or cured cancers may be exceptions (confirm with trial site)
- People who have previously been treated with anlotinib or other medications that work by blocking blood vessel growth in tumours
- People who have previously received benmelstobart or other immunotherapy drugs that target PD-1, PD-L1, or CTLA-1 pathways, or similar checkpoint or immune-stimulating treatments
- People who are allergic to any ingredient in anlotinib or benmelstobart
- People who have conditions that make taking oral medications difficult, such as an inability to swallow, ongoing diarrhoea, or a bowel blockage
- People with serious or uncontrolled health conditions, including: uncontrolled high blood pressure; significant heart conditions such as heart attack, certain abnormal heart rhythms, or moderate-to-severe heart failure; abnormal blood clotting or a tendency to bleed; active serious infections; severe liver disease or active hepatitis needing treatment; kidney failure requiring dialysis; a history of immune system deficiency including HIV, or a history of organ transplant; poorly controlled diabetes; significant protein in the urine; seizures requiring treatment; or long-term unhealed wounds or fractures
- People who have had significant coughing up of blood (more than 50 mL per day) within 2 weeks before joining, or who have current significant bleeding symptoms or signs of bleeding such as gastrointestinal bleeding or positive stool blood tests
- People whose scans show the tumour has grown into major blood vessels, or where the treating doctor considers there to be a high risk of the tumour causing serious bleeding
- People who have a history of interstitial lung disease (scarring or inflammation of the lung tissue), including drug-related lung disease or radiation-related lung inflammation requiring steroid treatment, or any currently active interstitial lung disease
- People who have had a stroke, transient ischaemic attack (mini-stroke), deep vein thrombosis, or pulmonary embolism (blood clot in the lung) within the past 6 months
- People who currently have nerve damage affecting their limbs rated at grade 2 or above (unless caused by a physical injury)
- People who have had major surgery or serious physical trauma within 14 days before joining, where recovery is not yet complete
- People who are currently taking part in another clinical trial, or who finished treatment in a previous clinical trial less than 4 weeks ago
- People who received a live or weakened (attenuated) vaccine within 30 days before the first dose of benmelstobart, or who plan to receive such a vaccine during the study
- People with a known history of severe allergic reactions to other monoclonal antibody treatments
- People who are pregnant or currently breastfeeding
- People with a known history of significant neurological or psychiatric conditions, including epilepsy or dementia
- People who, in the treating doctor's judgement, have other serious medical conditions, significant abnormal test results, or other circumstances that could affect their safety or the reliability of the study data
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
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Tang-Du Hospital
Registry
ClinicalTrials.gov
Start date
1 April 2025
Est. completion
1 February 2027
Primary endpoints
Complete pathological response (pCR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 1 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.