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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT06978153
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, sign a consent form, follow the study requirements, and attend follow-up appointments.
- People aged 18 to 75 years (inclusive) at the time of signing the consent form, of any gender.
- People whose lung cancer has been confirmed as small cell lung cancer (SCLC) through a tissue sample test.
- People whose SCLC has been confirmed as a limited stage (stage I to IIIB, meaning the cancer has not spread widely beyond the chest area), based on the AJCC 9th Edition staging system.
- People who have received exactly 1 cycle of chemotherapy and no other prior treatments for this cancer.
- People with a good general level of physical functioning — specifically, an ECOG Performance Status score of 0 (fully active) or 1 (restricted in strenuous activity but able to do light work).
- People who the treating doctor has assessed as having no medical reasons that would prevent surgery.
- People who have at least one measurable tumour, as defined by standard imaging measurement criteria (RECIST 1.1).
- People whose life expectancy is at least 8 weeks.
- Women of childbearing age (15–49 years) who have a negative blood pregnancy test within 7 days before starting treatment, and who agree to use reliable contraception throughout the study and for 8 weeks after stopping treatment.
- People whose blood test results meet the following requirements (without having received blood transfusions, blood products, or certain blood-stimulating treatments in the 14 days prior): haemoglobin at least 90 g/L; neutrophil count at least 1.5×10⁹/L; platelet count at least 80×10⁹/L.
- People whose liver and kidney function blood test results meet the following requirements: total bilirubin no more than 1.5 times the upper limit of normal; liver enzymes (ALT/AST) no more than 2.5 times the upper limit of normal; creatinine no more than 1.5 times the upper limit of normal, or kidney filtration rate of at least 60 mL/min.
- People whose urine protein level is below 2+; and, for those not on blood-thinning medication, clotting test results within acceptable ranges (INR no more than 1.5, APTT no more than 1.5 times the upper limit of normal). People who are on full-dose or injected blood thinners may be considered if their dose has been stable for at least 2 weeks and their clotting results are within the target treatment range.
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 small cell lung cancer has been confirmed as a mixed type (containing other cell types).
- People with extensive-stage SCLC (cancer that has spread widely).
- People with an ECOG Performance Status score above 1, meaning their general physical functioning is significantly reduced.
- People who have active or untreated cancer that has spread to the brain or central nervous system, confirmed by CT or MRI scan.
- People with tumour-related pain that is not well controlled.
- People with fluid build-up around the lungs, heart, or abdomen that is not controlled and requires draining at least once a month.
- People with uncontrolled or symptomatic high calcium levels in the blood above specified thresholds.
- People who have received immune-stimulating medications (such as interferon-alpha, interleukin-2, or TNF) within 4 weeks before enrolling (prior cancer vaccines are permitted).
- People who have taken corticosteroids at doses above 10 mg of prednisone per day (or equivalent) or immune-suppressing medications within the past 14 days, with certain exceptions such as low-dose replacement therapy, topical or inhaled steroids, or short-term use for specific non-autoimmune conditions.
- People whose tumour, as seen on imaging, is invading major blood vessels or is considered at high risk of serious bleeding by the treating doctor, or whose tumour has cavities or areas of tissue breakdown.
- People who have had another type of cancer within the past 5 years, except for certain early-stage or cured cancers (cervical carcinoma in situ, cured basal cell skin cancer, or certain early-stage bladder tumours).
- People who have previously been treated with anlotinib or any other medication that targets blood vessel growth in tumours.
- People who have previously received immune checkpoint therapy drugs targeting PD-1, PD-L1, or CTLA-4, or similar treatments that work on T-cell pathways.
- People who have a known allergy or hypersensitivity to anlotinib or to the components of benmelstobart.
- People who have difficulty swallowing tablets or other conditions that would prevent them from taking oral medication properly, such as chronic diarrhoea or a bowel obstruction.
- People with uncontrolled high blood pressure (systolic at or above 150 mmHg or diastolic at or above 100 mmHg).
- People with certain heart conditions, including heart attack or ischemia of grade 1 or higher, irregular heart rhythms (including a QTc interval of 480 ms or more), or heart failure classified as NYHA Class II or worse.
- People with abnormal blood clotting results, a tendency to bleed, or who are receiving clot-dissolving or blood-thinning treatment (with exceptions for low-dose preventive heparin or low-dose aspirin, provided clotting results remain within acceptable limits).
- People with active or severe infections that are not under control.
- People with cirrhosis, advanced liver disease, or active or chronic hepatitis requiring antiviral treatment.
- People with kidney failure requiring dialysis.
- People with immune system deficiencies, including HIV-positive status, inherited or acquired immune deficiency conditions, or a history of organ transplantation.
- People with poorly controlled diabetes (fasting blood sugar above 10 mmol/L).
- People with urine protein at ++ or higher, or a 24-hour urine protein level above 1.0 g.
- People with epilepsy that requires ongoing treatment.
- People with wounds or fractures that have not healed.
- People who have had significant coughing up of blood (more than 50 mL per day within the past 2 weeks) or clinically significant bleeding from other sources, such as gastrointestinal bleeding or a bleeding stomach ulcer, or a stool occult blood test result of ++ or higher at baseline.
- People with interstitial lung disease (ILD), lung inflammation caused by medication, radiation-related lung inflammation requiring steroid treatment, or currently active ILD.
- People who have had a blood clot or stroke (including mini-strokes/TIA), deep vein thrombosis, or pulmonary embolism within the past 6 months.
- People with significant nerve damage affecting sensation or movement in the limbs, rated as grade 2 or worse (not caused by injury).
- People who have had major surgery or serious physical trauma with ongoing effects within the past 14 days.
- People who are currently enrolled in another clinical trial, or who have received treatment in another trial within the past 4 weeks.
- People who have received a live or weakened (attenuated) vaccine within 30 days before starting benmelstobart, or who plan to receive one during the study.
- People with a history of severe allergic reactions to monoclonal antibody treatments.
- People who are pregnant or breastfeeding.
- People with psychiatric or neurological conditions that are not well controlled and that could affect their ability to follow the study requirements.
- People who, in the treating doctor's judgement, have other factors that could make participation unsafe or affect the reliability of the study data, such as serious illness, significant abnormal test results, or significant personal or family circumstances.
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: +8615991269383
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
Tang-Du Hospital
Registry
ClinicalTrials.gov
Start date
20 May 2025
Est. completion
1 November 2027
Primary endpoints
event-free survival (EFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 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.