Stage III Non-small Cell Lung Cancer
Conditions
Keywords
non-small cell lung cancer, radiomics, immunotherapy, chemoradiotherapy
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.
Interventions
DIAGNOSTIC_TESTCT
Contrast-enhanced thoracic computed tomography
Sponsors
Shenzhen University
Guangdong Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYi Pan
Outcome results
None listed