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

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.
• 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

i. Emergence of solid components within 12 months before the time of screening for patients with pure GGO nodules OR ii. Enlargement of solid components within 12 months before the time of screening for patients with partial solid nodules OR iii. Enlargement of the overall size of lung nodule leading to increase in predicted risk by 5% within 12 months before the time of screening 2. Male/female participants who are at least 18 years of age on the day of signing informed consent with diagnosis of high-risk IPNs as defined below will be enrolled in this study.

• A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 12 weeks while receiving pembrolizumab plus an additional 120 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
• 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.
• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of study enrollment.
• Have adequate organ function as defined in the following table (Table 4). Specimens must be collected within 10 days prior to the start of study treatment.

Table 4 Adequate Organ Function Laboratory Values Hematological

• Absolute neutrophil count (ANC) = ≥1500 per microliter (within 10 days prior to the start of study treatment).
• Platelets = ≥100, 000 per microliter (within 10 days prior to the start of study treatment).
• Hemoglobin = ≥ 9.0 grams per microliter or = ≥ 5.6 millimoles/liter (within 10 days prior to the start of study treatment) (*criteria must be met without erythropoietin dependency and without p