The study is a prospective,multi-center,single arm,real world study to evaluate safety and performance of Atezolizumab plus chemotherapy in patients with extensive-stage small-cell lung cancer,and also to explore potential biomarkers for Immune-related Adverse Events.
In 2018,the results of IMpower 133 were reported on WCLC.Meanwhile,the data was published in NEJM.Atezolizumab combined with carboplatin and etoposide for extensive stage small cell lung cancer was recommended as the first by NCCN guidelines quickly. Atezolizumab plus chemotherapy was approved by NMPA on Feb 13,2020,making Atezolizumab for 1L ES-SCLC in China. Real world study can reflect the efficacy and safety of treatment in clinical practice.Based on the research of public database,the prospective cohort study had been reported,but the study based on Chinese patients still left weak point.
Study Type
OBSERVATIONAL
Enrollment
300
Other chemotherapy:Irinotecan;topotecan;Enrotinib;Bevacil
Peking union medical college hospital,
Beijing, Beijing Municipality, China
RECRUITINGOS
Duration of overall survival
Time frame: Baseline until death from any cause(up to approximately 23 months)
irAE
Percentage of participants with Immune-related
Time frame: Baseline until up to 90 days after end of treatment(up to approximately 46 months) and related biomarkers
PFS
Duration of Progression-Free Survival as assessed by the Investigator using Recist v1.1
Time frame: Baseline until PD or death,whichever occurs first(up to approximately 23months)]
Treatment related biomarkers
Biomarkers:CD 4+,CD28+,PD L1,TMB etc.
Time frame: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
Quality of Life (QL)
QL as assessed by using EORTC
Time frame: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
) Score
QLQ C30 Score and EORTC QLQ Lung cancer module (LC13)Score
Time frame: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
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