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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07654400
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 requirements
- People of any gender are eligible
- People aged 18 years or older
- People with an expected survival time of at least 3 months
- People who have been diagnosed with extensive-stage small cell lung cancer (confirmed by laboratory tissue or cell testing) that cannot be cured or for which no standard treatment currently exists
- People who are able to provide stored tumor tissue samples from within the last 3 years, or fresh tissue samples
- People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1)
- People with a functional ability score of 0 or 1 on a standard scale used by doctors to assess how cancer affects daily activities (ECOG scale)
- People whose side effects from previous cancer treatments have mostly resolved to a mild level or better
- People with no serious heart problems, and whose heart pumping function (left ventricular ejection fraction) is at least 50%
- People whose organ function meets the required levels set by the trial (confirm with trial site)
- People with low levels of protein in their urine (within specified limits)
- Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding; all participants, regardless of gender, are required to use reliable barrier contraception throughout treatment and for 7 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 who have received chemotherapy, biological therapy, immunotherapy, or similar treatments within 4 weeks or 5 half-lives before the first dose
- People who have previously been treated with a type of drug called an ADC (antibody-drug conjugate) that uses topoisomerase I inhibitors as its active component
- People whose cancer pathology shows a mixture of small cell and non-small cell lung cancer components
- People who have used immune-modifying drugs within 2 weeks before the first dose
- People who are receiving ongoing high-dose steroid therapy (more than 10 mg per day of prednisone or an equivalent dose) before the first dose
- People with a history of serious heart or stroke-related conditions
- People with certain heart rhythm abnormalities, such as a prolonged QTc interval or complete left bundle branch block
- People with active autoimmune or inflammatory diseases
- People who have been diagnosed with another cancer within the past 5 years before the first dose
- People with high blood pressure that remains poorly controlled despite taking two blood pressure medications
- People with poorly controlled blood sugar levels
- People with a history of a lung condition called interstitial lung disease or interstitial pneumonia that required steroid treatment
- People with other existing lung diseases that cause significant breathing problems
- People with large or symptomatic fluid build-up around their organs (such as in the chest or abdomen)
- People whose imaging scans show the tumour has grown into or wrapped around major blood vessels in the chest, neck, or throat area
- People who have had a blood clot event within 6 months before joining the trial
- People with cancer that has actively spread to the brain or central nervous system
- People with a history of allergic reactions to certain types of antibody-based medicines or to any ingredient in the study drug
- People who have previously had an organ transplant or a stem cell transplant from a donor
- People who received a high cumulative dose of a type of chemotherapy called anthracyclines (more than 360 mg/m²) during prior treatment
- People who test positive for HIV, or who have active tuberculosis, active hepatitis B, or active hepatitis C
- People with active infections that require medical treatment, or who have had a serious infection within 4 weeks before signing the consent form
- People who have taken another unapproved study drug or participated in another unapproved clinical treatment within 4 weeks before the first dose
- People who are pregnant or breastfeeding
- People with a history of serious neurological or psychiatric conditions
- People who have had wounds, ulcers, or bone fractures that have not healed properly within 4 weeks before signing the consent form
- People who have had significant bleeding or a clear tendency to bleed within 4 weeks before signing the consent form
- People with a history of bowel obstruction, inflammatory bowel disease, large bowel removal surgery, Crohn's disease, ulcerative colitis, or ongoing chronic diarrhoea
- People who have received or plan to receive a live vaccine within 28 days before the first dose
- People whom the trial investigators consider unsuitable for any other reason
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
Not Yet Recruiting
Phase
Phase 2
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 December 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective Response Rate (ORR); Treatment-Emergent Adverse Event (TEAE)
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.