Pembrolizumab in Preventing Lung Cancer in Patients With Stage I-II Non-Small Cell Lung Cancer or… (NCT03634241) | Clinical Trial Compass
CompletedPhase 2
Pembrolizumab in Preventing Lung Cancer in Patients With Stage I-II Non-Small Cell Lung Cancer or High-Risk Pulmonary Nodules, the IMPRINT-Lung Study
United States45 participantsStarted 2018-11-13
Plain-language summary
This phase II trial studies how well pembrolizumab works in preventing lung cancer patients with stage I-II non-small cell lung cancer or high-risk pulmonary nodules. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants with no history of lung cancer, who have IPNs detected by LDCT-guided lung cancer screening or imaging studies for other reasons (incidentalomas) with 10 - 30% cancer probability by Brock University cancer prediction equation as following47. This is one of the most frequently utilized cancer risk prediction equations and has been confirmed to be highly effective in catching the disease in its very early stages by large national studies.
. Participants with no history of lung cancer, who have IPNs detected by LDCT-guided lung cancer screening or imaging studies for other reasons (incidentalomas) with \> 30% cancer probability by Brock University cancer prediction equation as following, but biopsy reveals no clear evidence of malignancy.
. Participants with history of stage I-II non-small cell lung cancer (NSCLC), who have completed curative treatment (surgery and/or radiation) with or without chemotherapy, who have persistent IPNs (on two CT scans at least 3 months apart with no evidence of shrinkage or regression) with 5-30% cancer probability by Brock University cancer prediction equation as following.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
6-month CT Assessment (Tumor Response Per mRECIST)
. Participants with history of stage I-II NSCLC, who have completed curative treatment (surgery and/or radiation) with or without chemotherapy, who have persistent IPNs (on two CT scans at least 3 months apart with no evidence of shrinkage or regression) with \> 30% cancer probability by Brock University cancer prediction equation as following, but biopsy reveals no clear evidence of malignancy.
. Persistent IPNs with estimated cancer probability ≥ 5% AND at least one of the following criteria
. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days for study treatments with risk of genotoxicity after the last dose of study treatment.