Printed from Voxsanity (voxsanity.com.au) — NCT06951841 — 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
NCT06951841
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 take part, sign a consent form, follow the study requirements, and attend follow-up appointments
- People aged 18 or older
- People who have been confirmed through tissue or cell testing to have extensive-stage small cell lung cancer (a type of lung cancer that has spread beyond one side of the chest)
- People with a physical functioning score of 0–2 on a standard scale used by doctors to measure how well a person can carry out daily activities (confirm with trial site)
- People who have not previously had any systemic treatment for extensive-stage small cell lung cancer, including chemotherapy, certain targeted therapies, or immunotherapy
- People who had limited-stage small cell lung cancer and completed radiation, chemotherapy, or a combination of both more than 6 months ago
- People with a life expectancy of at least 3 months
- People who have at least one measurable tumour lesion meeting standard imaging criteria (tumour measuring more than 10mm on a CT scan); people with brain metastases that are not causing symptoms may be able to receive brain radiation during the early phase of chemotherapy
- People whose blood cell counts meet required levels without having needed a blood transfusion, growth factors, or corrective medication in the 14 days before testing (specific thresholds to be confirmed with trial site)
- People whose liver function test results fall within the required ranges (specific thresholds to be confirmed with trial site)
- People whose kidney function falls within the required ranges, based on blood or calculated measures (specific thresholds to be confirmed with trial site)
- People whose blood clotting results fall within the required ranges (specific thresholds to be confirmed with trial site)
- Women who could become pregnant must have a negative pregnancy test (blood or urine) within 72 hours before the first dose, and must agree to use a highly effective form of contraception throughout the study and for 90 days after the last dose, and must not breastfeed
- Men must either have had a surgical procedure to prevent fathering children, or must agree to use a highly effective form of contraception during the trial and for 90 days after the last dose
- Women must agree not to breastfeed during the study or for 180 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 who have cancer that has spread to the membranes surrounding the brain or spinal cord, or who have brain metastases causing symptoms
- People who have previously received certain types of immunotherapy, including treatments targeting CTLA-4, PD-1, PD-L1/2, CD137, or other T cell–directed therapies
- People who have previously been treated with a drug called anlotinib
- People who have difficulty swallowing or have conditions affecting the digestive system, such as previous bowel surgery, ongoing severe diarrhoea, or bowel obstruction
- People with uncontrolled fluid build-up around the lungs or abdomen
- People who have an active autoimmune disease or a history of certain autoimmune conditions (such as inflammation of the eye, gut, liver, pituitary gland, blood vessels, heart muscle, kidneys, or thyroid); some conditions may be considered on a case-by-case basis (confirm with trial site)
- People with a weakened immune system due to a condition present from birth or acquired, including HIV infection, active hepatitis B, active hepatitis C, or a combination of hepatitis B and C
- People whose urine or 24-hour urine collection shows significant levels of protein, or who have severe liver or kidney impairment
- People who have needed systemic corticosteroids (such as prednisone at more than 10mg per day or an equivalent dose) or other immune-suppressing medications within 14 days before the first dose; inhaled or topical steroids and low-dose replacement therapy may be permitted (confirm with trial site)
- People who have received anti-cancer vaccines or other immune-stimulating cancer treatments (such as interferon, interleukin, thymosin, or immune cell therapy) within 1 month before the first dose
- People who have had another type of cancer within the past 5 years, with some exceptions for certain treated early-stage cancers (confirm with trial site)
- People with evidence of current or past lung scarring, inflammation, or other significant lung conditions
- People with uncontrolled high blood pressure despite treatment (blood pressure at or above 140/90 mmHg)
- People with significant heart problems, including certain types of heart rhythm abnormalities, reduced heart pumping function, a heart attack in the 6 months before enrolment, uncontrolled chest pain, or signs of acute heart stress on an ECG
- People who had a serious infection within 4 weeks before the first dose, or who have an unexplained fever above 38.5°C during the screening period
- People who had major surgery, an open biopsy, or a significant injury within 28 days before enrolment
- People who experienced a blood clot in an artery or vein within the past 6 months
- People assessed by the study doctor as being at significant risk of serious bleeding or related complications
- People with a history of receiving a transplanted organ or bone marrow/stem cells from another person
- Women who are pregnant or breastfeeding, or people who are unwilling or unable to use effective contraception
- People who have a known allergy to any of the study drugs or their ingredients
- People with any other condition that the study doctor believes could put them at risk or prevent them from completing the study requirements
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.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 4
Sponsor
China Medical University, China
Registry
ClinicalTrials.gov
Start date
30 April 2025
Est. completion
31 May 2026
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression-free survival (PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 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.