Printed from Voxsanity (voxsanity.com.au) — NCT07661173 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07661173
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 and able to sign a written consent form before any trial-related procedures begin.
- People who are at least 18 years old.
- People who have been diagnosed with a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC), confirmed by laboratory testing of tissue or cells.
- People whose lung cancer has tested positive for a specific gene change called an EGFR-sensitive mutation, confirmed through tissue, cell, blood, or fluid testing.
- People who have a performance score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physical activity (confirm with trial site).
- People who have at least one measurable area of cancer visible on imaging scans, according to standard measurement guidelines called RECIST v1.1.
- People who are expected to live for more than 3 months at the time of starting the trial.
- People newly diagnosed with locally advanced (stage IIIB–IIIC), metastatic, or recurrent (stage IV) lung cancer according to an international cancer staging system, where surgery or radiotherapy is not considered appropriate.
- People whose cancer has tested positive for an EGFR mutation, confirmed through tissue, cell, or blood testing.
- People who have not previously received anti-angiogenic drugs or chemotherapy.
- People with brain metastases (cancer that has spread to the brain) may be eligible if certain additional conditions are met (confirm with trial site).
- People whose blood test results show adequate bone marrow function: a neutrophil count of at least 1.5×10⁹/L without growth factor support in the past 14 days, platelets of at least 100×10⁹/L without recent transfusion, and haemoglobin above 9g/dL without recent transfusion or medication support.
- People whose liver function blood tests are within acceptable ranges, including total bilirubin no more than 1.5 times the upper limit of normal, and liver enzyme levels (AST and ALT) no more than 2.5 times the upper limit of normal (or up to 5 times if liver metastases are present).
- People whose kidney function is within acceptable ranges, with serum creatinine no more than 1.5 times the upper limit of normal and a calculated creatinine clearance rate of at least 60 ml/min.
- People with adequate blood clotting function, defined as INR or prothrombin time no more than 1.5 times the upper limit of normal.
- People with normal thyroid function, or those whose thyroid hormone levels (T3/FT3 and FT4) are within the normal range even if TSH is slightly outside it.
- People whose heart enzyme blood tests are within the normal range, or where any minor abnormality is judged by the investigator to have no clinical significance.
- Women of childbearing age who have a negative pregnancy test (urine or blood) taken within 3 days before the first dose.
- People who are able and willing to use highly effective contraception (with a failure rate of less than 1% per year) throughout the treatment period and for 120 days after the last dose (or 180 days after the last dose, depending on the treatment received).
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 lung cancer is small cell lung cancer (SCLC), or a mixed type containing both SCLC and NSCLC.
- People who have received systemic anti-cancer treatment (such as chemotherapy, targeted therapy, immunotherapy, or certain herbal medicines with anti-cancer indications) within 3 weeks before starting the trial.
- People who have taken part in another clinical trial involving an investigational drug within 4 weeks before starting the trial.
- People who have received high-dose immunosuppressive drugs (systemic steroids at a dose equivalent to more than 10mg/day of prednisone) within 4 weeks before starting the trial.
- People who have received a live attenuated vaccine within 4 weeks before starting the trial, or who plan to receive one during the study.
- People who have had major surgery (such as open chest surgery) within 4 weeks before starting the trial, or who have wounds, ulcers, or fractures that have not yet healed.
- People with pleural or abdominal fluid build-up that cannot be controlled clinically (confirm with trial site for specific details on what "uncontrollable" means in this context).
- People with a history of a lung condition called interstitial lung disease (ILD), drug-related ILD, radiation-related lung inflammation that required steroid treatment, or any signs of currently active ILD.
- People who have received high-dose chest radiotherapy (more than 30 Gy) within 6 months before starting the trial, or lower-dose palliative chest radiotherapy (30 Gy or less) within 7 days before starting the trial (palliative radiotherapy to bones or the brain is allowed).
- People who have had an active autoimmune disease requiring systemic treatment within the past 2 years before the first dose (hormone replacement therapies such as thyroxine or insulin are not considered systemic treatment in this context).
- People who have previously had an organ transplant from another person (excluding corneal transplants) or a bone marrow/stem cell transplant from another person.
- People who have not fully recovered from side effects or complications of any previous treatment before starting the trial (confirm with trial site for grading details).
- People with a known history of HIV infection (positive HIV 1/2 antibody test).
- People with untreated active hepatitis B, defined as a positive HBsAg result with HBV-DNA levels above the laboratory's upper limit of normal (people with hepatitis B who meet specific viral load and treatment criteria may still be considered — confirm with trial site).
- People with active hepatitis C infection, defined as a positive HCV antibody result with detectable HCV-RNA levels.
- People who have received a live vaccine within 30 days before the first dose (injected inactivated influenza vaccines are permitted; nasal spray live influenza vaccines are not).
- Women who are pregnant or breastfeeding.
- People with significant or uncontrolled heart rhythm problems, conduction abnormalities, or structural heart changes visible on a resting ECG, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmia, or atrial fibrillation.
- People with unstable angina, congestive heart failure, or chronic heart failure classified as NYHA grade 2 or higher.
- People who have had a heart attack within 6 months before enrolling.
- People with poorly controlled high blood pressure (systolic above 140 mmHg or diastolic above 90 mmHg).
- People with a history of non-infectious lung inflammation that required steroid treatment within 1 year before the first dose, or currently active interstitial lung disease.
- People with active tuberculosis.
- People with an active or uncontrolled infection requiring systemic treatment.
- People with clinically active diverticulitis, an abdominal abscess, or a bowel obstruction.
- People with liver conditions such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis.
- People with poorly controlled diabetes, defined as a fasting blood glucose level above 10 mmol/L.
- People with significant protein in their urine, confirmed by both a urine test result of ++ or more and a 24-hour urine protein level above 1.0 g.
- People with a mental health condition that would prevent them from cooperating with treatment.
- People with any medical history, condition, treatment, or test result that the investigator believes could interfere with the trial results, prevent full participation, or otherwise make participation unsuitable.
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.
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
Phone: 13805695536
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
Anhui Provincial Cancer Hospital
Registry
ClinicalTrials.gov
Start date
6 June 2026
Est. completion
6 March 2029
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression-free survival (PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 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.