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

  • STATUS
    Recruiting
  • days left to enroll
    24
  • participants needed
    20
  • sponsor
    Sun Yat-sen University
Updated on 2 February 2021

Summary

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.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Total body PET/CT (uExplorer)
Clinical Study IdentifierNCT04654234
SponsorSun Yat-sen University
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

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
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