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Phase 2 Lung Cancer Trial, Recruiting
NCT04317534
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 aged 18 or older at the time of giving consent.
- People who are willing and able to sign a written consent form to take part in the study (or have a legal representative do so on their behalf).
- People who are generally in good physical health and able to carry out daily activities with little or no limitation, as measured by a standard health scale (called ECOG Performance Status 0–1), assessed within 28 days before joining the study.
- People who have had complete surgical removal of stage I non-small cell lung cancer (NSCLC) between 4 and 12 weeks before joining the study, with no cancer left behind at the surgical edges (called "clear margins" or R0 resection).
- People whose removed lung tumour measured between 1.0 cm and 4.0 cm at its widest point. For a specific type of lung cancer called lepidic predominant adenocarcinoma, only the invasive (active) part of the tumour is measured — if that invasive part is less than 1 cm, the person would not meet this size criterion even if the total tumour is larger.
- People whose lung cancer surgery was completed at least 28 days before joining the study.
- People who have had a CT scan of the chest within 28 days before being assigned to a study group, showing no remaining signs of cancer.
- People who have either previous genetic testing (NGS) and a specific protein test (PD-L1 using Dako 22C3) results available, or who can provide stored tissue samples from their surgery so these tests can be done. If genetic test results are not already available, a minimum number of stored tissue slides from the surgery must be available.
- People whose blood test results show the kidneys, liver, and other organs are working well enough, tested within 28 days before joining the study.
- Women who could potentially become pregnant must have a negative pregnancy test (urine or blood) within 72 hours before joining the study.
- Women who could potentially become pregnant must not be pregnant or breastfeeding, and must either be using a highly effective form of contraception (with a failure rate of less than 1% per year) or be in a long-term and consistent practice of abstinence, continuing for at least 120 days after the last dose of the study drug.
- People who have had hepatitis B (HBV) infection may be eligible if they have been on antiviral treatment for at least 4 weeks and have an undetectable hepatitis B virus level in their blood before joining the study. (Hepatitis B testing is only required if there is a known history of infection or if local health authorities require it.)
- People with a history of hepatitis C (HCV) infection may be eligible if the hepatitis C virus is undetectable in their blood and they have completed curative antiviral treatment at least 4 weeks before joining the study. (Hepatitis C testing is only required if there is a known history of infection or if local health authorities require it.)
- People living with HIV may be eligible if their HIV is well managed on stable antiretroviral therapy (ART) for at least 4 weeks, their immune cell count (CD4+ T-cells) is at or above 350 cells/mm³, their HIV levels in the blood are undetectable, and they have not had any serious HIV-related infections in the past 12 months. (HIV testing is only required if local health authorities require it.)
- People who are able to understand and follow the study procedures for the full length of the study, as assessed by the enrolling doctor.
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 tumour was smaller than 1 cm or larger than 4 cm, or whose cancer was stage II, III, or IV.
- People whose tumour is known to have a specific gene change called an actionable EGFR mutation.
- People who have already received chemotherapy, radiation therapy, or immunotherapy to treat this lung cancer.
- People who have another active cancer that is growing or has needed active treatment within the past 2 years. (Some exceptions may apply for certain low-risk or early-stage cancers such as certain skin cancers, carcinoma in situ, or low-risk early prostate cancer — confirm with trial site.)
- People who have previously been treated with certain types of immunotherapy drugs that target the immune system's checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar drugs).
- People who have received a live or live-attenuated vaccine within 30 days before the first dose of the study drug. (Non-live, "killed" vaccines are allowed.)
- People who are currently in, or have recently been in, another clinical trial using an experimental drug or device within 4 weeks before the first dose of the study drug. (People who have moved to a follow-up phase of another study may be eligible if it has been at least 4 weeks since their last dose of that experimental drug — confirm with trial site.)
- People who have been diagnosed with an immune system deficiency, or who are receiving ongoing steroid treatment at a dose higher than the equivalent of 10 mg per day of prednisone, or who are on any other immune-suppressing medication within 7 days before being assigned to a study group.
- People who have received an organ or tissue transplant from another person (allogenic transplant).
- People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
- People who have an active autoimmune disease (a condition where the immune system attacks the body) that has needed systemic medical treatment in the past 2 years. Hormone replacement therapies (such as thyroid hormone or insulin) are not considered systemic treatment for this purpose.
- People who have a history of non-infectious inflammation of the lungs (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition.
- People who have an active infection that requires treatment with systemic medication (such as antibiotics given by mouth or through a drip).
- People who have an active tuberculosis (TB) infection.
- People living with HIV who have a history of Kaposi's sarcoma or Multicentric Castleman's Disease.
- People who have any medical condition, past or current, that in the treating doctor's opinion could affect the study results, prevent participation for the full study duration, or make participation not in the person's best interest.
- People with known psychiatric conditions or substance use disorders that would make it difficult to follow the study's requirements.
- People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and for 120 days after the last dose of the study drug.
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
Principal Investigator: Greg Durm, MD, Indiana University
Phone: 317-944-3940
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Recruiting
Phase
Phase 2
Sponsor
Greg Durm, MD
Registry
ClinicalTrials.gov
Start date
5 May 2020
Est. completion
8 April 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Disease Free Survival (DFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 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.