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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT04153734
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 have been diagnosed with non-small cell lung cancer (NSCLC) confirmed by a tissue sample (biopsy).
- People whose cancer tests show a PD-L1 score of 50% or higher (a marker measured on cancer cells that affects how certain treatments work).
- People with locally advanced NSCLC that cannot be removed by surgery (unresectable Stage III), where the treatment plan includes chemotherapy combined with radiation therapy aimed at curing the disease, based on standard cancer staging guidelines.
- People who have not yet received any treatment for their primary cancer.
- People whose cancer has at least one area that can be measured on a scan, according to standard measurement guidelines (RECIST 1.1).
- People who have a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are fully active or have minor restrictions in physically demanding activity but can carry out light work (confirm with trial site).
- People whose blood and organ tests meet the required levels, specifically:
- Blood cell counts: neutrophils at least 1,500 per microlitre, platelets at least 100,000 per microlitre, and haemoglobin at least 9.0 g/dL — without needing blood-boosting injections or a blood transfusion in the past 2 weeks.
- Kidney function: creatinine or kidney filtration rate within acceptable limits as defined by the trial.
- Liver function: bilirubin, AST, and ALT levels within acceptable limits as defined by the trial.
- Blood clotting: clotting test results (INR, PT, aPTT) within acceptable limits, or within a safe therapeutic range if already on blood-thinning medication.
- Thyroid hormone (TSH): within the normal range for the testing site, or if slightly outside that range, other thyroid hormones (T3 and free T4) must be within normal range.
- People who are at least 20 years old at the time of signing the consent form.
- Male participants who agree to use contraception during the treatment period and for at least 120 days after the last dose, and who agree not to donate sperm during this time.
- Female participants who are not pregnant and not breastfeeding, and who either are not of childbearing potential, or who agree to follow the trial's contraception guidelines during treatment and for at least 120 days after the last dose.
- People whose case has been reviewed at a medical conference that includes radiation oncologists.
- People (or their legal representative, where applicable) who are able and willing to provide written consent to take part in the trial.
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.
- Women of childbearing potential who have a positive pregnancy test within 72 hours before being assigned to a treatment group.
- People who have previously been treated with certain immune checkpoint therapies, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar drugs that act on the immune system's T-cell responses.
- People who have previously received any systemic (whole-body) anti-cancer treatment.
- People who have received a live vaccine within 30 days before starting the trial — examples include measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, typhoid, and nasal spray flu vaccines (note: standard injectable flu vaccines are generally permitted).
- People who are currently taking part in, or have taken part in, another clinical trial of an investigational drug or device within the past 4 weeks (those in a follow-up phase of a previous trial may be eligible if it has been at least 4 weeks since their last dose — confirm with trial site).
- People who have been diagnosed with an immune deficiency condition, or who are taking steroid medication at a dose above the equivalent of 10 mg of prednisone per day, or who are taking any other immune-suppressing medication within 7 days before starting the trial.
- People who have another cancer that is currently growing or has needed active treatment within the past 5 years (note: certain skin cancers and carcinoma in situ that have been treated with the aim of cure may not be excluded — confirm with trial site).
- People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
- People who have an autoimmune disease that has needed systemic medical treatment in the past 2 years (note: standard hormone or replacement therapies such as thyroid hormone or insulin are not considered systemic treatment for this purpose).
- People who have a history of pneumonitis (lung inflammation not caused by infection) that required steroid treatment, or who currently have pneumonitis.
- People who have an active infection that requires treatment with systemic (whole-body) medication.
- People who have a history of organ or tissue transplantation.
- People with a known history of HIV (Human Immunodeficiency Virus).
- People with a known history of active Hepatitis B or active Hepatitis C infection.
- People with a known history of active tuberculosis (TB).
- People who, in the opinion of the treating doctor, have any condition, previous treatment, or test result that could affect the trial results or make participation not in their best interest.
- People with known psychiatric conditions or substance use problems that would make it difficult to meet the requirements of the trial.
- People who are pregnant, breastfeeding, or planning to conceive or father a child during the study period, from the screening visit through to 120 days after the last dose of the trial treatment.
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Kobe Minimally Invasive Cancer Center
Registry
ClinicalTrials.gov
Start date
1 December 2019
Est. completion
30 November 2021
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.
Primary endpoints
2-year PFS rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 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.