WCLC 2025 - Posters & ePosters-PT1.01.03 IMPRINT-Lung: Single-Arm, Multi-Center Phase II Trial of Immunotherapy With Pembrolizumab for Interception of High-Risk Lung Nodules

PT1.01.03 IMPRINT-Lung: Single-Arm, Multi-Center Phase II Trial of Immunotherapy With Pembrolizumab for Interception of High-Risk Lung Nodules

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Pdf Summary

The IMPRINT-Lung trial is a single-arm, multi-center phase II study investigating the use of pembrolizumab, an anti-PD-1 immunotherapy, to intercept persistent high-risk lung nodules and prevent lung cancer progression. Persistent nodules are defined as those without regression on at least two CT scans three months apart, with eligibility based on predicted malignancy risk using the Brock model (≥10% for patients without lung cancer history, ≥5% for those with localized lung cancer). Nodules with risk ≥30% require biopsy confirming no malignancy before treatment.<br /><br />Forty patients received at least one dose of pembrolizumab and completed 6 months of follow-up. The treatment was generally well tolerated, with mostly Grade 1 toxicities observed. Three patients experienced Grade 2 pembrolizumab-related toxicities (pruritus, hypothyroidism), and two had Grade 3 toxicities unrelated to treatment (retinal detachment, hypertension). <br /><br />At 6 months post-treatment, among 36 evaluable patients, 2 showed disease progression, 1 achieved partial response (-34% reduction per mRECIST), and 18 showed various degrees of nodule shrinkage (median 3%, mean 5%). All patients exhibited prior nodule enlargement before pembrolizumab, indicating disease activity.<br /><br />The study rationale is based on evidence that lung cancer precursors possess simpler molecular profiles and more intact immune responses than invasive cancer, with immune evasion mechanisms like PD-L1 upregulation emerging early. Pembrolizumab aims to reprogram the tumor immune microenvironment to prevent malignant transformation.<br /><br />Ongoing analyses include radiomics and peripheral blood biomarker profiling. Primary endpoints assess nodule regression at 24 weeks, while secondary endpoints evaluate lung cancer incidence, cancer-free survival, overall survival, safety, and quality of life.<br /><br />In conclusion, pembrolizumab shows preliminary efficacy and favorable safety in treating high-risk lung nodules. Immune interception at the precancerous stage represents a promising strategy for lung cancer prevention. Further biomarker studies will refine patient selection and therapeutic impact.

Asset Subtitle

Jianjun Zhang

Meta Tag

Speaker Jianjun Zhang

Topic Risk Factors, Risk Reduction & Tobacco Control

Keywords

IMPRINT-Lung trial

pembrolizumab

anti-PD-1 immunotherapy

high-risk lung nodules

lung cancer prevention

Brock model

nodule regression

immune interception

radiomics

biomarker profiling