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Phase 3 Lung Cancer Trial, Not Yet Recruiting
NCT04465968
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
- A confirmed diagnosis of non-small cell lung cancer has been obtained through a biopsy of the main tumour.
- The tumour directly invades the chest wall at or above the level of the first rib (at least reaching the outer lining of the lung), or it directly invades the large blood vessels (subclavian artery or vein) near the collarbone, as seen on chest CT scan.
- Based on CT and specialised PET/CT imaging, the cancer has either not spread to nearby lymph nodes, has spread only to certain nearby lymph nodes (not nodes numbered #10, #11, or #12), or has spread only to the lymph nodes just above the collarbone on the same side as the tumour (with no other nearby lymph node involvement beyond #13 and #14).
- There is no sign of the cancer having spread to distant parts of the body, including other parts of the lung, based on imaging including PET/CT.
- A specialist surgeon has assessed that complete surgical removal of the tumour by removing one or two lobes of the lung is possible, and has confirmed none of the following are present: tumour growing into the spine in a way requiring full spinal removal, tumour growing into the spinal cord, tumour invading the windpipe or its main branching point, tumour invading the main artery near the heart, tumour invading certain high nerves in the neck (C8 or above), tumour invading the food pipe in a way that would require its reconstruction, or a need to remove the entire lung for complete removal.
- Lung function tests taken within 56 days before joining the trial show the lungs are expected to work well enough after surgery (predicted post-operative breathing volume of at least 800 mL in one second).
- Blood oxygen levels measured within 14 days before joining the trial are above 93% while breathing normal room air.
- A radiation therapy specialist has confirmed that radiation treatment is possible according to the study plan, and that the radiation field would not reach the area where the lung meets major airways and blood vessels (the hilum).
- The person is aged between 20 and 75 years old at the time of joining the trial.
- General health and ability to carry out daily activities meets ECOG Performance Status 0 or 1 (meaning fully active or restricted only in physically strenuous activity), as recorded in medical notes.
- Whether or not there are measurable lesions visible on scans is not a requirement for joining.
- There is no history of surgery — whether for a benign or cancerous condition — involving any of the following: chest surgery (by keyhole or open) that removed any part of the lung, food pipe, or middle chest structures on the affected side (note: keyhole chest surgery that did not include any such removal, such as a pleural biopsy, is allowed); surgery through the breastbone (with or without organ removal); or removal of part of the lung on the opposite side beyond a small wedge removal.
- There is no history of chemotherapy of any kind, including treatments for other cancers such as targeted therapies or immunotherapy — except that prior drug therapy given as a preventive (adjuvant) treatment is allowed if it was fully completed more than 3 years ago, and prior hormone therapy for other cancers is also allowed.
- If the person has previously had radiation therapy (including for other cancers), the radiation did not cover the lung, hilum, middle chest, or the area above the collarbone.
- Chest CT shows no signs of scarring or inflammation of the lung tissue (interstitial pneumonia or pulmonary fibrosis).
- There is no history of autoimmune disease (where the body's immune system attacks itself), whether ongoing, recurring, or past — except that the following well-controlled conditions may still be eligible: type 1 diabetes managed with appropriate treatment; an overactive or underactive thyroid requiring only standard medication; certain skin autoimmune conditions not needing systemic treatment (such as pemphigus, psoriasis, vitiligo); and coeliac disease managed by diet alone — provided these have been inactive for the past 5 years.
- No surgery under general anaesthetic has taken place within 14 days before joining the trial.
- No systemic (whole-body) steroids, other immune-suppressing medications, or immunoglobulins have been taken within 28 days before joining the trial — except the following are permitted: nasal, inhaled, topical, or locally injected steroids; systemic steroids at a low dose (10 mg/day or less of prednisolone or equivalent); and steroids used as a pre-medication (for example, before a CT scan).
- The person is able to swallow and take medication by mouth.
- A recent ECG (heart tracing) taken within 28 days before joining shows no signs of reduced blood flow to the heart — or, if such signs are present, further heart tests have been done and a doctor has confirmed no new heart treatment is needed.
- Blood test results from within 14 days before joining the trial meet all of the following: white blood cell count at least 4,000/mm³; haemoglobin at least 11.0 g/dL (with no blood transfusion in the 14 days before the blood test); platelet count at least 10×10⁴/mm³; total bilirubin no more than 2.0 mg/dL; liver enzymes AST and ALT each no more than 75 U/L; and creatinine (a kidney marker) no more than 1.2 mg/dL.
- Written consent to participate in the study has been given by the person.
- The treating doctor has assessed that the person understands the treatment and assessment schedule for the study and is able to follow it.
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 currently have an active second cancer, or who have had another cancer within the past 3 years — although certain early-stage cancers that have been fully treated may not count as "active" under the trial's specific rules (confirm with trial site).
- People who have an active infection requiring treatment throughout the body, including active tuberculosis.
- People who have a fever of 38.0°C or higher at the time of joining the trial.
- Women who are pregnant, possibly pregnant, have given birth within the past 28 days, or are breastfeeding; men who intend for their partner to become pregnant; or any person of reproductive capacity who is unwilling to use effective contraception up until 13 weeks (91 days) after the last dose of the study drug durvalumab.
- People whose mental health condition or symptoms significantly interfere with daily life, making participation in the study considered too difficult.
- People who are continuously taking systemic (whole-body) steroids or other immune-suppressing drugs at a dose greater than 10 mg/day of prednisolone or equivalent.
- People with diabetes that is not well controlled.
- People with high blood pressure that is not well controlled.
- People with a bowel condition causing uncontrolled diarrhoea.
- People with unstable chest pain (angina that has newly appeared or worsened within the past 3 weeks), or who have had a heart attack within the past 6 months.
- People with significant heart valve disease, an enlarged heart (dilated cardiomyopathy), a thickened heart muscle (hypertrophic cardiomyopathy), heart failure, or uncontrolled irregular heart rhythm.
- Chest CT showing severe emphysema (a type of serious lung damage).
- People who test positive for Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 antibody.
- People who require ongoing use of the antifungal medication flucytosine (Ancotil®).
- People who have participated in another clinical trial (not including observational studies) within the 6 months before joining this trial.
- People who have had an organ transplant from another person (allogeneic transplant).
- People with a history of an active primary immune deficiency condition.
- People who have received a live vaccine (such as BCG, measles, mumps, rubella, chickenpox, yellow fever, rotavirus, or similar) within 30 days before joining the trial.
- People with a known hypersensitivity or allergy to the study drug or any of its ingredients.
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.
Contact this trial
Phone: +81-4-7133-1111
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 3
Sponsor
National Cancer Center Hospital East
Registry
ClinicalTrials.gov
Start date
1 September 2020
Est. completion
31 August 2027
Primary endpoints
3-year overall survival rate (3y-OS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.