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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07501169
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 give their voluntary written agreement to take part before any study procedures begin.
- People aged 18 to 75 years, of any sex.
- People with a general health and activity level rated as 0 or 1 on a standard oncology scale (meaning fully active or able to carry out light work), as assessed by the trial site.
- People with a life expectancy of at least 3 months.
- People who have been confirmed through laboratory testing of tissue or cell samples to have small cell lung cancer (SCLC) at an advanced (extensive) stage.
- People whose cancer has continued to grow or spread after receiving at least two cycles of a platinum-based chemotherapy treatment (with or without certain immunotherapy drugs), and who have received no more than two previous rounds of cancer treatment in total.
- People who have at least one measurable area of cancer that can be tracked according to standard imaging guidelines (RECIST v1.1), not including brain lesions as the only measurable site; previously treated areas may only count if clear progression has been confirmed there after treatment (confirm with trial site).
- People whose bone marrow is working well enough, without needing a blood transfusion or growth factor support in the 14 days before screening — specifically, meeting minimum blood count levels as assessed by the trial team.
- People whose liver is functioning adequately, based on standard blood test results falling within acceptable ranges as assessed by the trial team.
- People whose kidneys are functioning adequately, based on standard blood test results falling within acceptable ranges as assessed by the trial team.
- People whose blood clotting function is adequate, based on standard blood test results falling within acceptable ranges as assessed by the trial team.
- People whose heart is functioning adequately, including a heart pumping strength (ejection fraction) of at least 50% on a heart scan done within 28 days before joining, and a heart failure rating below class 3 on a standard scale.
- Women who could become pregnant must agree to use effective contraception from the time of signing consent until 6 months after the last dose of study treatment.
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 had another type of cancer in the 5 years before signing consent, unless it was fully treated with no return within 5 years, or was a specific type considered cured (such as certain skin cancers, cervical pre-cancer, or thyroid cancer).
- People previously diagnosed with a mixed or transformed form of lung cancer (for example, a combination of small cell and non-small cell lung cancer, or one type that has changed into another).
- People who have received certain anti-cancer treatments too recently before the first study dose — including chemotherapy, radiation, immunotherapy, or other cancer medicines — within timeframes set out by the trial (ranging from 2 weeks to 6 weeks depending on the treatment type).
- People who have taken part in another clinical trial or received an experimental treatment within 4 weeks before the first study dose.
- People who have previously received or are currently using a class of anti-cancer drugs called topoisomerase I inhibitors, including certain antibody-drug combinations that carry this type of drug (examples include topotecan, irinotecan, and several others).
- People with cancer that has spread to the brain, unless it has been stable and symptom-free for at least 4 weeks with minimal or no steroid use; people with cancer spread to the membranes around the brain or brainstem, spinal cord compression, or cancer spread into the bone marrow are not eligible.
- People whose tumour is located very close to or is invading major blood vessels, or where the trial team judges there to be a high risk of serious bleeding.
- People who have had a serious blood clot event (such as a stroke, deep vein clot, or lung clot) within the past 6 months, unless the clot was fully treated or was a minor surface clot with low bleeding risk as judged by the trial team.
- People who still have side effects from previous cancer treatment rated at grade 2 or higher on a standard scale, except for hair loss, certain nerve-related effects, or stable low thyroid managed with medication.
- People who have had major surgery or serious physical trauma within 4 weeks before the first study dose, or who have planned surgery during the study period (minor procedures such as biopsies are generally excluded from this).
- People who have received a live or live-weakened vaccine within 4 weeks before the first study dose.
- People who have used high-dose steroid medications or other immune-suppressing drugs within 14 days before the first study dose, with certain exceptions such as inhaled, topical, or short-term preventive steroids.
- People with a history of lung inflammation (interstitial lung disease or pneumonitis) that required ongoing steroid treatment, or who currently have or are suspected to have this condition based on screening scans.
- People with active tuberculosis, active or uncontrolled autoimmune disease, immune deficiency conditions, or a history of organ or bone marrow transplant.
- People who have had a serious infection within 4 weeks before the first study dose, including infections requiring intravenous antibiotics or severe pneumonia.
- People who test positive for HIV, or who have active hepatitis B or C infections that are detectable in the blood and are not being adequately managed (confirm with trial site for specific criteria around antiviral treatment).
- People with significant heart conditions, including serious heart rhythm problems, a heart electrical interval that is too long on an ECG, heart failure, unstable chest pain, a recent heart attack, stroke or mini-stroke, certain blood clots, or blood pressure that remains too high despite treatment.
- People with uncontrolled fluid build-up in body cavities (such as around the lungs or in the abdomen) that requires active drainage; people with certain types of fluid around the heart may also not be eligible (confirm with trial site for specific exceptions).
- People with a known allergy or serious reaction to any of the study drugs or comparison drugs used in the trial (such as topotecan, irinotecan, or paclitaxel).
- People with a substance use disorder, alcohol or drug dependence, or a medical or mental health condition that the trial team believes would interfere with taking part safely or reliably.
- Women who are pregnant or breastfeeding, or men or women who plan to try to conceive during the study period.
- People who the trial team believes are unlikely to follow the study requirements, or who have other serious health conditions making participation unsuitable.
- People with bleeding disorders (such as active stomach ulcers), or who require blood-thinning medications, except where low-dose preventive use falls within limits set by the trial team; also people whose tumour imaging suggests a high bleeding risk.
- People with serious or uncontrolled ongoing health conditions, including but not limited to active infections, certain liver or digestive conditions, poorly controlled diabetes, high levels of protein in urine, abnormal calcium levels, non-healing wounds, or psychiatric conditions affecting treatment compliance.
- People with conditions that affect the ability to swallow or absorb oral (by mouth) medications, such as chronic diarrhoea or bowel obstruction.
- People with documented severe dry eye syndrome, serious eyelid or gland conditions, or a history of corneal eye disease that affects healing.
- People who the trial team considers 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
Principal Investigator: Jianxin Xue, West China Hospital
Phone: 86-028-85423581
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 University
Registry
ClinicalTrials.gov
Start date
1 April 2026
Est. completion
31 August 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective Response Rate (ORR)
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.