Total-body PET/CT Imaging Using the uEXPLORER in Non-small Cell Lung Cancer Patients Treated by Neoadjuvant Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiotherapy

Study Overview
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Brief Summary
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The prospective study aims to explore the value of total-body PET/CT dynamic imaging (uExplorer) in assessing tumor metabolic heterogeneity and predicting prognosis for patients with locally advanced, unresectable non-small cell lung cancer (stage III) treated by neoadjuvant chemotherapy plus nivolumab and definitive concurrent chemoradiation therapy.

Official Title
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Total-body PET/CT Imaging Using the uEXPLORER in Non-small Cell Lung Cancer Patients Treated by Neoadjuvant Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiotherapy

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Device: Total body PET/CT (uExplorer)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedures; Patients aged 18 75 years old; had histologically or cytologically confirmed non-small cell lung cancer; Without prior chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy; Life expectancy ≥12 weeks; World Health Organization (WHO) Performance Status of 0 or 1; had unresectable stage III disease according to the 8th edition of the American Joint Committee on Cancer staging system; Women should be non-breast feeding during the study period; Women of reproductive age (WOCBP) must agree to comply with the contraceptive method during the study treatment and for a period of 5 months following the last administration of the study treatment; Men who have sex with WOCBP must agree to comply with the contraceptive method during the study treatment and for 7 months after the last administration of the study treatment; Absolute neutrophil count ≥1500/uL, hemoglobin ≥9.0mg/dL, platelet ≥100000/uL; Serum creatinine clearance >50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976); Serum bilirubin ≤1.5 x upper limit of normal (ULN), Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤2.5 x ULN; Forced expiratory volume in 1 second (FEV1) ≥800ml; Exclusion Criteria: Concurrent enrollment in another clinical study, unless it is an observational(non-interventional) clinical study; Mixed small cell and non-small cell lung cancer histology; Prior exposure to any anti-programmed cell death protein(PD)-1 or anti- PD-L1 antibody; Active or prior documented autoimmune disease within the past 2 years; Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis); History of primary immunodeficiency; Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses; History of another primary malignancy within 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study; Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control; Any situation not suitable for this study judged by researchers;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Total-body PET/CT (uExplorer)<br>Patients with locally advanced NSCLC will receive total-body PET/CT (uExplorer) scans before, during and after the treatment | Device: Total body PET/CT (uExplorer)<br>* A total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER) with a 192-cm scan range was applied for cancer diagnosis, organ function assessment and treatment outcome prediction. The total-body PET scanner can acquire scans with lower administered activity or short acquisition time, total-body dynamic acquisition at a longer delayed time point, and high detectability of exiguous changes of the whole body, and tumor as well.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor standard uptake value (SUV) | The dynamic change of tumor SUV examined by total-body PET/CT (uExplorer) | From randomisation to 1 year after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal tissue standard uptake value (SUV) | The dynamic change of tumor SUV examined by total-body PET/CT (uExplorer) | From randomisation to 1 year after radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small Cell Lung Cancer, Total-body PET/CT, uEXPLORER, Nivolumab