2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.07H.01 Analysis of Variables Predicting pCR and irAEs in Resectable NSCLC Receiving Neoadjuvant Immunotherapy with Chemotherapy (Pre-PLaN)

EP.07H.01 Analysis of Variables Predicting pCR and irAEs in Resectable NSCLC Receiving Neoadjuvant Immunotherapy with Chemotherapy (Pre-PLaN)

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The study "Analysis of Variables Predicting pCR and irAEs in Resectable NSCLC Receiving Neoadjuvant Immunotherapy with Chemotherapy" is focused on identifying factors that predict pathological complete response (pCR) and immune-related adverse events (irAEs) in patients with resectable non-small cell lung cancer (NSCLC) who receive neoadjuvant chemo-immunotherapy. <br /><br />**Primary Objectives**: The study aims to assess the predictive power of various clinical, demographic, radiological, blood-based biomarkers, and pathological/genomic variables for predicting pCR and irAEs. It also plans to develop a predictive model employing sensitivity, specificity, and ROC curves.<br /><br />**Secondary Objectives**: It includes evaluating objective response rates, exploring novel biomarkers for responses and irAEs, and investigating the accuracy of F18-FDG-PET-CT and blood-based molecular assays in predicting pCR.<br /><br />**Study Design**: This is a single-center, prospective study involving participants with stage IB, II, or IIIA NSCLC who are eligible for surgery. The treatment protocol comprises three cycles of neoadjuvant nivolumab-chemotherapy followed by surgery. Participants must meet specific criteria, including measurable disease and tumor tissue availability for PD-L1 testing, and should not have EGFR mutations, known autoimmune diseases, or require certain immunosuppressive treatments.<br /><br />**Significance**: The study is expected to enhance patient selection for neoadjuvant immunotherapy, identify those needing additional treatments, and highlight novel treatment targets. By understanding biological differences between responders and non-responders, the research may inform treatment strategies to overcome resistance.<br /><br />**Timeline**: The study began in February 2024, with patient accrual over 30 months. The final analysis is scheduled for February 2027.<br /><br />**Hypothesis**: The research hypothesizes the development of a predictive model with an AUC of at least 0.8, combining various predictive variables to forecast pCR in patients treated with neoadjuvant chemo-immunotherapy.

Asset Subtitle

Mark Vincent

Meta Tag

Speaker Mark Vincent

Topic Early-Stage Non-small Cell Lung Cancer

Keywords

NSCLC

neoadjuvant immunotherapy

pathological complete response

immune-related adverse events

predictive model

biomarkers

nivolumab

chemo-immunotherapy

F18-FDG-PET-CT

PD-L1 testing