Lung Cancer Trial, By Invitation
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
- The person must have given written consent before any trial-related steps are taken.
- The person must be between 60 and 80 years old.
- The person must have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is either locally advanced (stage IIIB–IIIC) or has spread to other parts of the body (stage IV), and the cancer cannot be treated with surgery or with chemotherapy combined with radiation at the same time, and no prior systemic treatment has been given.
- Testing on tissue samples must have confirmed that the cancer does not have certain genetic changes known as EGFR sensitive mutations or ALK gene fusions.
- There must be at least one area of cancer that can be measured on a scan, following standard measurement guidelines (RECIST v1.1).
- The person must not have received any prior systemic (whole-body) cancer treatment for advanced or metastatic disease — though people who received platinum-based chemotherapy or chemoradiotherapy earlier are allowed if their cancer came back or progressed at least 6 months after the last chemotherapy dose.
- People with brain metastases (cancer that has spread to the brain) that are stable and not causing active symptoms may be eligible, provided there are measurable areas of cancer outside the brain, symptoms have been stable for at least 2 weeks, and steroid treatment is either not needed or has been reduced to a low dose (confirm with trial site).
- Palliative radiation therapy received at least 7 days before starting the trial drug is allowed, as long as any side effects from that radiation have reduced to a mild level or resolved.
- The person must have an ECOG performance score of 0–2, meaning they are reasonably active and able to carry out daily activities (confirm with trial site).
- The person's expected survival must be greater than 3 months.
- Blood test results must show adequate organ function, including: a sufficient level of infection-fighting white blood cells (neutrophils) without recent use of growth-stimulating injections; a healthy platelet count without recent blood transfusion; a haemoglobin level above 9 g/dL without recent transfusion or certain medications; liver function values (bilirubin, AST, ALT) within acceptable ranges; kidney function (creatinine and creatinine clearance) within acceptable ranges; normal blood clotting function; thyroid hormone levels within the normal range; and heart enzyme levels within the normal range.
- The person must be willing and able to follow the trial treatment plan.
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 been diagnosed with another cancer (other than certain skin cancers or cancers fully removed by surgery) within the past 5 years.
- People who are currently taking part in another clinical trial or who have received an investigational drug or device within the past 4 weeks.
- People who have previously been treated with certain immune checkpoint drugs, including anti-PD-1, anti-PD-L1, or similar immunotherapy agents (such as pembrolizumab, nivolumab, atezolizumab, durvalumab, ipilimumab, or similar medicines).
- People who have received certain Chinese herbal medicines or immune-boosting drugs used to treat NSCLC within the 2 weeks before starting the trial.
- People who have had an active autoimmune disease requiring ongoing systemic medical treatment within the past 2 years (hormone replacement therapies for conditions like thyroid or adrenal problems are not considered systemic treatment in this context).
- People who have uncontrolled fluid build-up around the lungs or abdomen that still requires ongoing drainage.
- People who have had an organ transplant (other than a corneal transplant) or a bone marrow/stem cell transplant from a donor.
- People who are known to be allergic to any of the study drugs or their ingredients (including sintilimab, pemetrexed, gemcitabine, carboplatin, or cisplatin).
- People who have not fully recovered from side effects of prior treatments (side effects must have reduced to a mild level or returned to baseline, except for fatigue or hair loss).
- People with a known history of HIV infection (positive HIV 1/2 antibody test).
- People with untreated active hepatitis B, defined as having a positive surface antigen (HBsAg) and virus levels above the laboratory's upper limit of normal (people with hepatitis B who meet specific viral load criteria and receive anti-hepatitis B treatment throughout the study may be eligible — confirm with trial site).
- People with active hepatitis C infection, shown by a positive hepatitis C antibody test and detectable hepatitis C virus in the blood.
- People who have received a live vaccine within 30 days before starting the trial (injected inactivated flu vaccines are allowed; live nasal spray flu vaccines are not).
- People with serious or uncontrolled heart problems, such as significant abnormalities on a resting ECG, unstable angina, heart failure (NYHA grade 2 or above), or a heart attack within the past 6 months.
- People with poorly controlled blood pressure (systolic above 140 mmHg or diastolic above 90 mmHg).
- People who have had non-infectious lung inflammation requiring steroid treatment within the past year, or who currently have active interstitial lung disease.
- People with active tuberculosis.
- People with an active or uncontrolled infection that requires systemic treatment.
- People with active diverticulitis, an abdominal abscess, or a bowel obstruction.
- People with serious liver disease, such as cirrhosis, liver failure, or active hepatitis.
- People with poorly controlled diabetes (fasting blood sugar above 10 mmol/L).
- People whose urine tests show significant protein in the urine, confirmed by a 24-hour urine test showing more than 1.0 g of protein.
- People with a psychiatric condition that would prevent them from being able to cooperate with treatment.
- People with any other medical condition, abnormal test results, or circumstances that the trial doctors consider could interfere with the trial or pose a risk to the person's participation.
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.
GP referral letter
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Trial details
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
Primary endpoints
ORR
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.