Printed from Voxsanity (voxsanity.com.au) — NCT07485920 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 4 Lung Cancer Trial, Not Yet Recruiting
NCT07485920
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 been fully informed about the study and have voluntarily signed a consent form.
- People aged 18 or older; any gender is eligible.
- People with a good general physical performance level, rated 0 or 1 on a standard medical scale called the ECOG score (confirm with trial site).
- People whose lung cancer has been confirmed as limited-stage small cell lung cancer through a tissue or cell sample test.
- People who have at least one tumour area that can be measured using standard imaging guidelines (called RECIST v1.1).
- People whose life expectancy is estimated to be at least 3 months.
- People who have received preventive brain radiation treatment before consolidation therapy are still eligible.
- People whose blood and organ function test results meet all of the following standards, without having received a blood transfusion or growth factor treatment in the 14 days before testing: a sufficient level of infection-fighting white blood cells, platelets, and red blood cells; healthy kidney function; healthy liver function including normal bilirubin, liver enzymes, and protein levels; and normal blood-clotting levels (if not on blood-thinning medication).
- People who are willing and able to attend all required visits, follow the treatment plan, and complete all tests and study procedures.
- Women who can become pregnant must have a negative blood pregnancy test taken within 3 days before the first dose, and both women who can become pregnant and male participants whose partners can become pregnant must agree to use effective contraception during the study and for 120 days after the last dose.
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 has spread from a cancer that started somewhere else in the body.
- People who currently have, or have previously had, another cancer anywhere in the body — except for certain skin cancers (basal cell or squamous cell) or in situ cancers that were fully removed and cured.
- People who have already received any other systemic treatment for their current lung cancer — such as chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy — other than the induction radiotherapy and chemotherapy that is part of this study.
- People who received certain immune-modifying medications (such as interferon, interleukin-2, or thymus-based treatments) within the 4 weeks before the first dose.
- People whose blood pressure remains too high despite medication (systolic 160 mmHg or above, or diastolic 100 mmHg or above).
- People who have conditions that would seriously affect how well they can absorb oral medications, such as difficulty swallowing, ongoing severe diarrhoea, or a bowel blockage.
- People where the treating doctor judges there is a significant risk that the tumour could invade a major blood vessel and cause life-threatening bleeding during treatment.
- People who, in the 3 months before the study, had significant coughing up of blood (more than 50 ml per day), other major bleeding episodes, or signs of a serious bleeding tendency (such as gastrointestinal bleeding, bleeding stomach ulcers, high levels of hidden blood in stool, or vasculitis).
- People who used any traditional Chinese medicine intended to treat cancer within the 14 days before the first dose.
- People who received a live vaccine in the 30 days before the first dose, or who are expected to need a live or weakened live vaccine during the study or within 5 months after the last dose (examples include vaccines for mumps, rubella, measles, chickenpox, yellow fever, rabies, BCG, and some typhoid vaccines; inactivated vaccines are permitted).
- People who needed treatment with corticosteroids above a low dose threshold, or other immune-suppressing drugs, within the 14 days before the first dose, where the treating doctor considers this would affect the study treatment.
- People with a systemic autoimmune disease that requires ongoing treatment, where the treating doctor considers this would affect the study treatment.
- People with interstitial lung disease, non-infectious pneumonia, or other uncontrolled conditions such as diabetes or pulmonary fibrosis, where the treating doctor considers this would affect the study treatment.
- People with a significant history of serious illness affecting any major organ system, where the treating doctor considers this would affect the study treatment.
- People who have an active serious infection requiring systemic antibiotic, antifungal, or antiviral treatment within the 14 days before the first dose — including certain active hepatitis B cases (although people with lower hepatitis B virus levels who have been on antiviral treatment for at least 14 days and agree to continue may still be eligible — confirm with trial site), or active hepatitis C.
- People with uncontrolled active hepatitis B or active hepatitis C (as defined by specific virus level tests during screening — confirm with trial site for details).
- People known to have HIV infection.
- People with severe heart failure (Grade III–IV by a standard heart classification scale) or poorly controlled, clinically significant irregular heartbeat.
- People who have had an arterial blood clot, blockage, or loss of blood supply to an organ in the 6 months before joining — such as a heart attack, unstable chest pain, stroke, or mini-stroke.
- People who are currently taking part in another treatment-based clinical trial, unless it is an observational (non-treatment) study or they are only in the follow-up phase of a previous study.
- People with any medical history, condition, or abnormal test result that the treating doctor believes could interfere with study results, prevent full participation, or pose other risks that make joining this study unsuitable.
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.
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.
Contact this trial
Phone: 0532-82913035
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 4
Sponsor
The Affiliated Hospital of Qingdao University
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
10 December 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
progression-free survival（PFS）
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.