Phase 2 Lung Cancer Trial, Not Yet Recruiting
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 able to understand what the study involves and are willing to sign a consent form voluntarily.
- People aged 18 to 75 years, of any gender.
- People with a type of non-small cell lung cancer (NSCLC) that does not have certain gene changes ("driver gene-negative"), whose first-line standard treatment has stopped working, and who are not suitable for second-line treatment or other chemotherapy options.
- "Treatment failure" in this context means the cancer got worse during or after treatment — switching treatments because of side effects does not count as treatment failure.
- People who have at least one measurable tumour that can be tracked using standard imaging guidelines (RECIST v1.1).
- People whose general health and ability to carry out daily activities is rated as 0 or 1 on a standard scale (ECOG performance status), meaning they are fully active or have only minor limitations.
- People whose doctor estimates they have a life expectancy of at least 3 months.
- People who agree to have a tumour tissue sample (biopsy) taken before starting the study treatment and, if medically appropriate, during treatment.
- People whose blood test results, taken within 7 days before the first dose, show that their bone marrow, liver, kidneys, and blood clotting are working at adequate levels (confirm with trial site for specific values).
- People whose side effects from any previous cancer treatment have eased to a mild level (Grade 1 or lower) or have become stable, not counting hair loss or skin colour changes.
- People who are able to have children and agree to use highly effective contraception from the time of signing the consent form until 6 months after the last dose.
- People who are able to communicate clearly with the research team and are willing and able to follow the study's required check-up schedule.
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 received certain chemotherapy drugs or herbal medicines with anti-cancer effects within 14 days before the first dose.
- People who received radiotherapy, biological therapies (such as cancer vaccines, cytokines, or growth factors), or other immunotherapy treatments (not including PD-1/PD-L1 inhibitors) within 28 days or 5 half-lives of those treatments before the first dose, whichever is shorter — although short-course palliative radiotherapy to non-brain areas may be allowed with at least a 7-day gap before the first dose (confirm with trial site).
- People who received certain antibody treatments targeting IL-4Rα, anti-IgE antibodies, or similar biological treatments within 10 weeks or 5 half-lives before the first dose, whichever is longer.
- People who received live or weakened (attenuated) vaccines within 12 weeks before the first dose, or who plan to receive such vaccines during the study.
- People who have had a serious allergic reaction to anti-IL-4Rα antibody treatments, the study drug (Stapokibart Injection), or other protein-based treatments such as vaccines or immunoglobulins.
- People who had severe (Grade 3 or higher) or life-threatening immune-related side effects during previous immunotherapy — or who still have unresolved immune-related side effects at any level after stopping that therapy — with some exceptions for certain hormone-related side effects that can be managed with replacement medication (confirm with trial site).
- People with significant heart or blood vessel problems, including: a serious heart or stroke event (such as heart failure, heart attack, unstable chest pain, stroke, or blood clots) in the 6 months before the first dose; certain abnormal heart rhythm readings on an ECG; reduced heart pumping function; moderate-to-severe heart failure symptoms; or uncontrolled high blood pressure (confirm with trial site for specific values).
- People who are planning to have major surgery during the study period.
- People with active cancer spread to the brain (brain metastases) — although people with previously treated brain metastases that have been stable for at least 14 days, confirmed by repeat imaging at least 4 weeks apart during screening, may be considered (confirm with trial site).
- People with uncontrolled fluid build-up around the lungs, abdomen, or heart, as assessed by the treating doctor.
- People with an active tuberculosis (TB) infection.
- People who test positive for hepatitis C antibodies and also have detectable hepatitis C virus in their blood.
- People who have HIV or test positive for HIV antibodies during screening.
- People who have had another type of cancer in the past 5 years, with the exception of certain skin cancers or early-stage cancers that have been fully cured (confirm with trial site).
- People with an active autoimmune disease that has required systemic treatment (such as immune-suppressing or steroid medications) within the past 2 years — noting that hormone replacement therapies such as thyroid medication or insulin are generally permitted (confirm with trial site).
- People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor.
- People who are pregnant or breastfeeding.
- People with any other condition that the investigator believes could affect the study results, make it difficult to follow the study requirements, or put the person's safety at risk.
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.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Yongsheng Wang, West China Hospital, Sichuan University, Chengdu, Sichuan
Phone: 86（028）85421606
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
Primary endpoints
ORR
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.