Printed from Voxsanity (voxsanity.com.au) — NCT06514027 — 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
NCT06514027
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 fully understand the study, are willing to sign a consent form, and are able to complete all parts of the trial.
- People who are 18 years of age or older; both men and women are eligible.
- People who have been diagnosed (through tissue or cell testing) with a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that cannot be removed by surgery and is either locally advanced (stage IIIB or IIIC), has come back, or has spread to other parts of the body (stage IV), and who are unable to have or have chosen not to have a specific combined radiation and chemotherapy treatment.
- People who have not previously received systemic (whole-body) treatment for locally advanced or metastatic NSCLC — though earlier preventive or follow-up chemotherapy is allowed if it was finished at least 6 months before the cancer was found to have advanced or spread, and people who previously tried a drug called savolitinib without success are also allowed.
- People whose lung cancer has a specific gene change called an EGFR exon 20 insertion mutation, confirmed by a blood or tumour tissue test carried out by a qualified hospital or testing facility, with records available; other EGFR or HER2 gene changes may also be present.
- People who have at least one measurable area of cancer that meets standard measurement criteria (RECIST v1.1) at the time of screening; areas previously treated with radiotherapy cannot be used for measurement unless they have clearly grown again after treatment.
- People with a general health and activity score of 0 or 1 on a standard scale (ECOG), with no worsening in the two weeks before screening, and who are expected to live for at least 12 weeks.
- People whose blood test results show adequate bone marrow function — specifically: neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, and haemoglobin ≥90 g/L — without having received blood transfusions or certain blood-boosting medications in the 14 days before screening.
- People whose liver function blood tests are within acceptable ranges: total bilirubin no more than 1.5 times the upper limit of normal (or up to 3 times for people with a condition called Gilbert's syndrome), and liver enzymes (AST and ALT) no more than 2.5 times the upper limit of normal (or up to 5 times for people with liver spread of cancer).
- People whose kidney function is adequate, with a creatinine clearance of at least 45 ml/min, and whose urine protein levels are within acceptable limits.
- People whose blood clotting test results (APTT, PT, and INR) are within acceptable ranges (no more than 1.5 times the upper limit of normal for each).
- People with a history of liver cirrhosis who have a Child-Pugh score of A or B (with a score of 7 or below) at screening (confirm with trial site).
- People whose heart rhythm test (ECG) at screening shows a corrected QT interval (QTcF) within normal limits — up to 450 ms for men and up to 470 ms for women; if the first measurement is outside this range, two additional tests will be done and the average of all three used.
- People of childbearing potential (both men and women) who agree to use reliable contraception during the study and for at least 6 months after the last dose, who are not breastfeeding, and who have a negative blood pregnancy test before the first 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 with a history of severe allergic conditions (such as uncontrollable asthma), serious drug allergies, or a known allergy or intolerance to any ingredient in the study drug.
- People who have been diagnosed with another type of cancer in addition to NSCLC, unless it is certain types of treated skin cancer, cervical carcinoma in situ, non-spreading prostate cancer, or another cancer for which there has been no sign of return for at least 3 years after the last treatment and that carries a low risk of coming back.
- People who had major surgery within 28 days before the first study dose, who are expected to have surgery during the study, or who have ongoing complications from surgery performed within 2 months before the first dose (minor procedures such as catheter placement or small biopsies may be acceptable at the investigator's discretion).
- People who have fluid build-up around the lungs, in the abdomen, or around the heart that is causing significant symptoms or needs to be drained.
- People with poorly controlled diabetes, defined as a HbA1c (a blood sugar measure) of 8% or higher, or between 7% and 8% with symptoms such as excessive thirst, urination, hunger, or unexplained weight loss (people whose blood sugar has been brought under control with adjusted treatment may still be considered, at the investigator's discretion).
- People who received a live vaccine within 28 days before the first dose, or who plan to receive one during the study.
- People who have a tendency to bleed or have signs of bleeding, including: a history of active stomach or duodenal ulcers or perforations in the past 6 months, persistent positive stool blood tests, or a history of gastrointestinal bleeding conditions such as ulcerative colitis.
- People who have had coughing up of bright red blood within 2 weeks before the first dose, or who have wounds, ulcers, or fractures that have not healed.
- People with a condition called vasculitis (inflammation of the blood vessels).
- People with other conditions that the investigator determines may cause bleeding.
- People who have serious problems with their digestive system that may affect how the study drug is swallowed, moved through, or absorbed — such as an inability to swallow, uncontrollable vomiting, a history of large sections of the gut being surgically removed, chronic diarrhoea, long-term use of proton pump inhibitor (PPI) medications for stomach conditions, Crohn's disease, ulcerative colitis, or bowel obstruction.
- People who have cancer that has spread to the brain or nervous system (CNS metastasis), unless the spread is causing no symptoms, has been stable, and has not required any medication for at least 4 weeks before the start of the study treatment.
- People with current compression of the spinal cord (with or without symptoms, detected by imaging) or suspected cancer spread to the membranes surrounding the brain and spinal cord.
- People whose imaging scans (CT or MRI) show that the tumour has grown into major blood vessels or cannot be clearly separated from them.
- People who have had significant heart or stroke-related events in the 6 months before the first dose, including: a heart attack or unstable chest pain (angina); severe heart failure (NYHA class III or IV); reduced heart pumping ability or serious abnormalities in heart wall movement on scan; a history of serious irregular heart rhythms such as sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes; poorly controlled high blood pressure (systolic above 160 mmHg or diastolic above 100 mmHg); or blood clot-related events such as stroke, transient ischaemic attack (mini-stroke), deep vein thrombosis, or pulmonary embolism (note: low molecular weight heparin is allowed, but certain blood-thinning or anti-inflammatory medications including high-dose aspirin, clopidogrel, dipyridamole, ticlopidine, or cilostazol are not permitted during the study).
- People with other heart rhythm problems that the investigator considers unsuitable for the trial, such as a third-degree heart block.
- People with other serious or uncontrolled conditions that the investigator considers unsuitable for trial participation, including: lung inflammation (interstitial lung disease, radiation pneumonitis, or drug-related pneumonitis) requiring steroid treatment; uncontrolled hereditary or acquired clotting disorders; ongoing or active infections including active hepatitis B, hepatitis C, HIV, active syphilis without symptoms, or other active infections requiring systemic treatment within 14 days before the first dose.
- People with severe or unhealed wounds, ulcers, or fractures.
- People with a history of drug or alcohol misuse or mental illness.
- People who have taken medications or herbal supplements that strongly affect the way certain liver enzymes (CYP3A4 and CYP2C8) process drugs, within 14 days before the first dose.
- People who received high-dose radiotherapy to areas outside the chest (more than 30 Gy) within 28 days before the first dose, high-dose chest radiotherapy (more than 30 Gy) within 24 weeks before the first dose, or lower-dose palliative radiotherapy (30 Gy or less) within 14 days before the first dose.
- People who have taken part in another clinical trial and received a study drug within 4 weeks before the first dose.
- People who the investigator considers unsuitable for other reasons.
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
Principal Investigator: Li Zhang, Master, Sun Yat-sen University
Phone: +86-18664786382
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
BeBetter Med Inc
Registry
ClinicalTrials.gov
Start date
1 July 2024
Est. completion
1 June 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
ORR; AE
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 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.