Construction of CT Radiomics Model for Predicting the Efficacy of Immunotherapy in Patients With Stage III NSCLC

Study Overview
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Brief Summary
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Consolidation immunotherapy of immune checkpoint inhibitor (ICI) following chemoradiotherapy (CRT) is the current standard of care for patients with unresectable locally advanced non-small cell lung cancer (NSCLC) as it improves both progression-free survival and overall survival. However, a substantial proportion of patients still experience disease recurrence despite consolidation ICI. It is important for personalized treatment to predict the efficacy of consolidation ICI. PD-L1 expression is used as a predictive biomarker for ICI response and efficacy in advanced NSCLC, but its role in patients with stage III disease is unclear. One important reason is PD-L1 testing performed on pre-CRT tissue may not reflect changes in PD-L1 expression after CRT. CT-based radiomics approaches have been successfully applied to generate imaging biomarkers as decision support tools for clinical practice. The hypothesis of this study is that CT radiomics model can assess PD-L1 status after CRT and predict the efficacy of CRT combined with ICI in unresectable locally advanced NSCLC.

Detailed Description
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This is an observational longitudinal prospective study. CT scan is performed before radiotherapy, during radiotherapy and at the end of radiotherapy in patients with unresectable locally advanced NSCLC who undergo CRT. Radiomic features were extracted from CT images and baseline PD-L1 expression is assessed. CT-based radiomics models is developed to assess PD-L1 expression and predict the efficacy of ICI.

Official Title
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Construction of CT Radiomics Model to Assess PD-L1 Status and Predict the Efficacy of Chemoradiotherapy Combined With Immunotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer

Conditions
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Stage III Non-small Cell Lung Cancer

Intervention / Treatment
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* Diagnostic Test: CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological proven non-small cell lung cancer Unresectable stage III according to American Joint Committee of Cancer stage (the eighth edition) 18 years or older Exclusion Criteria: Previous thoracic radiotherapy Palliative treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trial cohort：Chemoradiotherapy followed by immunotherapy<br>Contrast-enhanced thoracic CT: before, during and after radiotherapy Radiomics PD-L1 testing (Histological analysis of biopsy) Molecular Markers (Histological analysis of biopsy) | Diagnostic Test: CT<br>* Contrast-enhanced thoracic computed tomography<br>* Other names: Radiomics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association of CT radiomics features with PD-L1 expression of the tumor | To construct a radiomics model for predicting PD-L1 expression after chemoradiotherapy | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between CT radiomics model and progression-free survival of chemoradiotherapy followed by ICI | To construct CT radiomics model for evaluating progression-free survival in patients undergo chemoradiotherapy followed by ICI | From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, assessed up to 5 years | 
| Association between CT radiomics model and overall survival of chemoradiotherapy followed by ICI | to assess the association between CT radiomics features and overall survival | From date of inclusion to the trial until the date of death from any cause, assessed up to 5 years | 
| Association between CT radiomics model and ICI related pneumonitis | To develop CT radiomics signatures for predicting ICI related pneumonitis | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiomics, non-small cell lung cancer, immunotherapy, chemoradiotherapy