Printed from Voxsanity (voxsanity.com.au) — NCT07502300 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Lung Cancer Trial, Recruiting
NCT07502300
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 sign a consent form and follow the study's requirements
- People aged 18 years or older
- People with an expected survival time of at least 3 months
- People with a good general level of physical functioning (rated 0 or 1 on a standard oncology performance scale, meaning fully active or able to carry out light activity)
- People whose small cell lung cancer has been confirmed through laboratory testing of tissue or cell samples, and whose cancer is classified as extensive-stage (meaning it has spread beyond one lung)
- People who are able to provide a stored tumor tissue sample from the past 3 years, or a fresh tissue sample
- People who have at least one measurable area of cancer that can be tracked using standard imaging criteria
- People whose side effects from any previous cancer treatment have mostly resolved to a mild level or better
- People with adequate heart function, specifically a heart pumping efficiency (left ventricular ejection fraction) of 50% or higher
- People whose liver, kidney, and other organ function meets the study's required levels (confirm with trial site for specific values)
- People with a low level of protein in their urine, within specified limits
- Women of childbearing potential who have a negative pregnancy test within 7 days before starting treatment and who are not breastfeeding; all participants, regardless of sex, must use effective barrier contraception throughout treatment and for 6 months after treatment ends
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 cancer contains a mix of small cell and non-small cell lung cancer components
- People who have previously received any systemic treatment for their cancer
- People who have previously been treated with a type of drug called an ADC (antibody-drug conjugate) that uses a topoisomerase I inhibitor as its active component
- People who have used immune-modifying medications in the 14 days before the first study dose
- People with a history of serious heart disease or stroke-related (cerebrovascular) disease
- People who have been taking corticosteroids (such as prednisone) at a dose greater than 10 mg per day, or an equivalent dose of another steroid, on an ongoing basis before starting the study
- People with active autoimmune diseases or ongoing inflammatory conditions
- People who have had unstable blood clotting events requiring treatment in the 6 months before screening
- People with certain heart rhythm or electrical conduction problems, such as a prolonged QT interval or complete left bundle branch block (confirm with trial site for full list)
- People who have been diagnosed with another active cancer within the past 3 years
- People whose high blood pressure is not adequately controlled despite using two blood pressure medications
- People with poorly controlled diabetes
- People with a history of a lung condition called interstitial lung disease (ILD) or pneumonitis that required steroid treatment
- People with another existing lung condition that significantly impairs their breathing
- People with active cancer spread to the brain or central nervous system
- People who have had a serious infection in the 4 weeks before joining the study
- People who have significant fluid build-up around their organs (such as around the lungs or in the abdomen), particularly if causing symptoms
- People whose scans show the cancer is growing into or wrapping around major blood vessels in the chest, abdomen, neck, or throat
- People with a serious wound, ulcer, or bone fracture that has not healed in the 4 weeks before signing the consent form
- People who have had significant or concerning bleeding in the 4 weeks before signing the consent form
- People with inflammatory bowel disease, a history of major bowel surgery, immune-related bowel inflammation, bowel obstruction, or chronic diarrhea
- People with a known allergy to the study drug (BL-B01D1) or any of its ingredients
- People who have had a stem cell transplant (either using their own or a donor's cells)
- People who test positive for HIV, or who have an active hepatitis B or hepatitis C infection
- People with a history of serious neurological or psychiatric conditions
- People who have taken another unapproved experimental drug or participated in another clinical trial within 4 weeks before joining this study
- People who have received, or are planning to receive, a live vaccine within 28 days before joining the study
- People who, in the treating doctor's judgement, have other medical or personal circumstances that make participation 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.
Contact this trial
Phone: 15013238943
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
Recruiting
Phase
Phase 3
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
15 June 2026
Est. completion
1 December 2029
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Overall survival (OS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 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.