This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs).
All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system and received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy. The peripheral blood samples at various time points including before radiation, 4 weeks after beginning of radiation, the end of radiation, 1 month post radiation, and 1 month post consolidation immunotherapy were collected for lymphocyte subsets detection. The subjects will be divided into two groups according to whether patients received ICIs, namely, NSCLC patients received CRT plus ICIs and NSCLC patients received CRT.
Study Type
OBSERVATIONAL
Enrollment
200
Thoracic radiation therapy(with the prescribed dose of 50-70 Gy), concurrently or sequentially combined with platinum-based doublet chemotherapy.
anti-PD-1/anti-PD-L1 immune checkpoint inhibitors
Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGAdverse Event
The incidence of adverse events (AEs) and serious adverse events (SAEs) is evaluated by CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.
Time frame: AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of study drug, up to 24 months.
Progression-free survival (PFS)
Defined as the time from date of first treatment until the date of first documented progression or date of death from any cause, whichever came first.
Time frame: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Overall survival (OS)
Defined as the time from the date of first treatment to the date of any documented death due to any cause.
Time frame: From the date of first treatment to the date of any documented death due to any cause, assessed up to 24 months.
Objective Response Rate (ORR)
The objective response rate (ORR) will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Tumor assessment using RECIST will be performed at baseline then every 3 months from the first treatment until objective progression or death from any cause, assessed up to 24 months.
Disease control rate (DCR)
DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.
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Time frame: Tumour assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 24 months.