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

• Conditions: Stage III Non-small Cell Lung Cancer
• Interventions: Diagnostic Test: CT

• Registration Number: NCT04984148
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2021-07-25
• Study First Submitted QC: 2021-07-25
• Study First Posted: 2021-07-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-06
• Last Update Posted: 2021-11-09
• Primary Completion: 2022-09-30
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trial cohort：Chemoradiotherapy followed by immunotherapy	CT	Contrast-enhanced thoracic CT: before, during and after radiotherapy Radiomics PD-L1 testing (Histological analysis of biopsy) Molecular Markers (Histological analysis of biopsy)

Primary Outcome Measures

Name	Time	Method
The association of CT radiomics features with PD-L1 expression of the tumor	12 weeks	To construct a radiomics model for predicting PD-L1 expression after chemoradiotherapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China