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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07376499
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 volunteer, sign a consent form, follow the study plan, and attend follow-up appointments.
- People aged 18 years or older.
- People who have been diagnosed with extensive stage small cell lung cancer (a type of lung cancer that has spread widely), confirmed by tissue or cell testing.
- People with a performance status score of 0 to 2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site).
- People who have not previously received any systemic treatment for extensive stage small cell lung cancer, including chemotherapy, certain targeted therapies, or immunotherapy.
- People who were previously diagnosed with limited stage small cell lung cancer and received radiation, chemotherapy, or combined treatment more than 6 months ago.
- People whose doctors estimate they are likely to live for at least 3 more months.
- People who have at least one measurable area of cancer that meets specific size requirements on a CT scan; people with brain metastases that are not causing symptoms may be able to receive brain radiation during early treatment.
- People whose blood, liver, kidney, and clotting test results fall within acceptable ranges as defined by the trial (confirm specific values with the trial site).
- Women who could become pregnant must have a negative pregnancy test within 72 hours before the first dose, and both women who could become pregnant and men whose partners could become pregnant must agree to use highly effective contraception during the study and for 90 days after the last dose.
- Men must either be surgically sterilised or agree to use highly effective 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 whose cancer 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 CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or similar drugs targeting immune cells.
- 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 prior bowel surgery, ongoing diarrhoea, or bowel obstruction.
- People with fluid build-up around the lungs or in the abdomen that cannot be adequately controlled.
- People who have an active autoimmune disease or a history of certain autoimmune conditions; some exceptions may apply for specific milder conditions (confirm with trial site).
- People with conditions affecting the immune system, including HIV infection, active hepatitis B, active hepatitis C, or co-infection with both hepatitis B and C.
- People whose urine or kidney tests show significant levels of protein in the urine, or who have severe liver or kidney problems.
- People who have needed corticosteroid tablets or other immune-suppressing medicines at certain doses within 14 days before the first dose; some exceptions apply for inhaled, topical, or low-dose replacement therapies (confirm with trial site).
- People who have received anti-cancer vaccines or certain immune-stimulating cancer treatments 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 fully treated early-stage cancers (confirm with trial site).
- People with a history of or current evidence of lung scarring, inflammatory lung disease, dust-related lung disease, radiation-related lung inflammation, drug-related lung damage, active pneumonia, or severely reduced lung function.
- People with high blood pressure that remains uncontrolled despite treatment.
- People with significant heart problems, including moderate to severe heart disease, poorly controlled abnormal heart rhythms, recent heart attack, heart failure, uncontrolled chest pain, severe irregular heartbeat, or abnormal electrical activity in the heart (confirm specific criteria with trial site).
- People who had a serious infection within 4 weeks before the first dose, or who have an unexplained fever above 38.5°C during screening.
- People who had major surgery, an open biopsy, or a serious injury within 28 days before joining the trial.
- People who had a blood clot in an artery or vein within the past 6 months.
- People assessed by the trial doctors as being at risk of serious bleeding or related complications.
- People who have previously had an organ transplant or a stem cell transplant from another person.
- Women who are pregnant or breastfeeding, or people who are unwilling or unable to use effective contraception.
- People with a known allergy to any of the trial drugs or their ingredients.
- People with any other condition that the trial doctors believe 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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
China Medical University, China
Registry
ClinicalTrials.gov
Start date
25 January 2026
Est. completion
31 March 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.
Primary endpoints
Progression-free survival (PFS) To evaluate the efficacy of anti-tumor
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 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.