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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07022301
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 at least 18 years old at the time of signing the consent form, regardless of gender.
- People who have been diagnosed with widespread, recurrent small cell lung cancer (confirmed by tissue or cell sample) that has come back and is getting worse more than 3 months after receiving standard immunotherapy.
- People who have at least one area of cancer that can be measured on a scan, according to standard measurement rules (areas previously treated with radiation must show clear signs of growth to count as measurable).
- People whose physical functioning is rated 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site).
- People whose life expectancy is estimated to be at least 3 months.
- People whose blood test results meet all of the following standards, without having had a blood transfusion or certain blood-boosting drugs in the 2 weeks before screening: haemoglobin at least 90 g/L; neutrophil count at least 1.5 × 10⁹/L; platelet count at least 90 × 10⁹/L; and white blood cell count between 3.0 × 10⁹/L and 15 × 10⁹/L.
- People whose other lab results meet all of the following standards, without having received a human serum albumin injection in the 14 days before screening: liver enzymes (AST and ALT) no more than 3 times the upper limit of normal; bone-related liver enzyme (ALP) no more than 2.5 times the upper limit of normal (or up to 5 times if bone spread is present); total bilirubin no more than 1 times the upper limit of normal; albumin at least 30 g/L; creatinine no more than 1.5 times the upper limit of normal with kidney clearance rate of at least 60 mL/min; thyroid hormone (TSH) within normal range, or if slightly outside range, the additional thyroid tests (FT3 and FT4) must be normal; and clotting tests (APTT, INR, PT) within acceptable limits for people not on blood-thinning medication.
- People whose heart electrical activity (QTc interval) is below 450 ms for men or below 470 ms for women, and whose heart pumping function (LVEF) is at least 50%.
- Women of childbearing age who are not pregnant (confirmed by a blood test within 3 days before the first dose) and are not breastfeeding, and who — along with male participants whose partners could become pregnant — agree to use effective contraception during the study and for at least 6 months after the last dose.
- People who willingly agree to take part, sign a consent form, and are able to follow the study requirements and attend follow-up visits.
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 scans show the cancer has grown into large blood vessels, or where the boundary between the tumour and blood vessels is not clear.
- People whose scans show large hollow or severely decayed areas within the tumour in the lungs.
- People who have brain metastases or cancer spread to the membranes around the brain or spinal cord that are causing symptoms.
- People who have cancer affecting the lining around the brain (malignant meningitis) or compression of the spinal cord.
- People who have had another type of cancer in the past or currently, unless it is a specific low-risk type (such as certain skin cancers, early-stage cervical cancer, or other cancers that went into full remission at least 5 years before screening and are not expected to need treatment during the study).
- People who have had or currently have certain lung conditions, including idiopathic pulmonary fibrosis, interstitial lung disease, dust-related lung disease, radiation-related lung inflammation, drug-related lung inflammation, or active lung infection, or whose lung function tests show severe impairment.
- People who have any active, known, or suspected autoimmune disease (such as lupus, rheumatoid arthritis, multiple sclerosis, or similar conditions), with the exception of well-controlled type 1 diabetes on stable insulin, thyroid conditions requiring only hormone replacement, or mild skin conditions not needing systemic treatment and without flare-ups in the past year.
- People with suspected or confirmed active tuberculosis, or a history of active tuberculosis within the past year; people with a history of tuberculosis more than one year ago may also be excluded unless it is clearly documented that they received the correct and complete treatment at the time (confirm with trial site).
- People with heart conditions that are not well controlled, including moderate-to-severe heart failure, unstable chest pain, a heart attack within the past year, or significant abnormal heart rhythms that require treatment.
- People with high blood pressure that cannot be brought under control with medication (top number 140 mmHg or higher, or bottom number 90 mmHg or higher).
- People whose urine test shows a significant level of protein in the urine, confirmed by a 24-hour urine collection showing more than 1.0 g of protein.
- People with a tendency to form blood clots or who are currently on clot-dissolving or blood-thinning therapy (though low-dose aspirin up to 100 mg/day and low-dose heparin up to 40 mg/day for prevention are permitted).
- People who received more than 30 Gy of chest radiation in the 6 months before joining the trial, or who had major surgery within 4 weeks before joining and have not yet sufficiently recovered from its side effects.
- People who have had a blood clot event in the 6 months before joining the trial, such as a stroke, mini-stroke, brain bleed, deep vein thrombosis, or pulmonary embolism.
- People who have coughed up more than 2.5 mL of blood per day in the month before joining the trial, who have a history of bleeding or clotting disorders, or who have had significant bleeding (such as gastrointestinal bleeding) in the 3 months before joining.
- People who had a serious infection in the month before joining the trial (including infections requiring hospitalisation, blood infections, or severe pneumonia), or who have any active infection, or who had an unexplained fever above 38.5°C during screening or before the first dose.
- People who received anti-cancer vaccines or certain immune-boosting drugs in the month before joining the trial, or who are expected to receive a live attenuated vaccine during the study.
- People who received systemic corticosteroids at doses above 10 mg/day of prednisone (or equivalent) or other immune-suppressing drugs in the month before joining the trial (inhaled, topical, or low-dose replacement steroids are generally permitted if there is no active autoimmune disease).
- People who are known to be HIV-positive or have AIDS, or who have active hepatitis B or C infection based on specific blood test results.
- People who are known to have had an allergic reaction to another monoclonal antibody medication, or to any ingredient in anlotinib.
- People who are currently in another clinical trial, or whose last dose in a previous clinical trial was less than 4 weeks ago (or less than 5 half-lives of that study drug, whichever applies).
- People who, in the judgement of the research team, have other factors that could affect the study results or their safety, such as alcohol or substance misuse, other serious illnesses requiring concurrent treatment, severely abnormal lab results, or personal or social circumstances that could affect safe participation.
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: 0553-5738279
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
First Affiliated Hospital of Wannan Medical College
Registry
ClinicalTrials.gov
Start date
1 July 2025
Est. completion
1 May 2027
Primary endpoints
ORR
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 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.