Trial results for the IMPRINT-Lung Study (NCT03634241) investigating pembrolizumab (Keytruda) in preventing lung cancer were posted on ClinicalTrials.gov on 2026-04-16. This Phase 2 trial, which enrolled 45 participants, focused on patients with Stage I-II non-small cell lung cancer or high-risk pulmonary nodules.

Background

Pembrolizumab is an immunotherapy drug. The IMPRINT-Lung Study (NCT03634241) specifically investigated its potential role in preventing lung cancer in patients diagnosed with Stage I-II non-small cell lung cancer or those with high-risk pulmonary nodules. As a monoclonal antibody, pembrolizumab is designed to help the body's immune system target and attack cancer cells.

Trial design

The IMPRINT-Lung Study (NCT03634241) was a Phase 2, single-arm trial that enrolled 45 participants. The study investigated pembrolizumab in patients with Stage I-II non-small cell lung cancer, including specific sub-stages such as Stage IA1, Stage IA2, and Stage IA3 Lung Cancer AJCC v8, as well as those with high-risk pulmonary nodules. The trial aimed to assess how well pembrolizumab works in preventing lung cancer in this population.

Key results

The trial results included data on 6-month CT assessment for tumor response per mRECIST in the single-arm pembrolizumab group. The counts of participants for this outcome were 1, 36, 2, and 1. Data for Disease Free Survival and Overall Survival were reported as NA (Not Applicable) for median values with 95% Confidence Intervals.

What this means

The completion and posting of results for this Phase 2 trial provide initial data regarding pembrolizumab in patients with early-stage non-small cell lung cancer or high-risk pulmonary nodules. While specific efficacy outcomes for Disease Free Survival and Overall Survival were reported as not applicable, the detailed participant counts for 6-month CT assessment are now publicly available for further analysis by researchers and clinicians. These results contribute to the understanding of pembrolizumab's profile in this specific patient population.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03634241, titled "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," were posted on 2026-04-16 on clinicaltrials.gov.