Real World Study of Efficacy and Safety of Atezolizumab Plus Chemotherapy in Chinese Patients With ES-SCLC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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First-line Atezolizumab Plus Chemotherapy in Patients With Extensive-stage Small-cell Lung Cancer:a Real World,Single Arm,Multicenter,Prospective Study in China

Conditions
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Extensive-stage Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Chemotherapy Drugs, Cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) No prior systemic treatment for ES-SCLC 18-80 years old, or more than 10 months of expected natural survival; Eastern Cooperative Oncology Group performance status of 0 or 1 or 2 Measurable disease, as defined by RECIST v1.1 Adequate hematologic and end organ function Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent Exclusion Criteria: Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or 6 months after the final dose chemotherapy. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment. Patients or family members cannot understand the conditions and goals of this study. The subject has an estimated life expectancy of less than 10 months The subject is unable or unwilling to comply with the study requirements or follow-up schedule

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A<br>200/Atezolizumab combined with EC regimen Atezolizumab:1200 mg Q3w | Drug: Chemotherapy Drugs, Cancer<br>* Other chemotherapy:Irinotecan;topotecan;Enrotinib;Bevacil<br>|
| Arm B<br>100/Atezolizumab combined with chemotherapy Atezolizumab:1200mg Q3w | Drug: Chemotherapy Drugs, Cancer<br>* Other chemotherapy:Irinotecan;topotecan;Enrotinib;Bevacil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Duration of overall survival | Baseline until death from any cause(up to approximately 23 months) | 
| irAE | Percentage of participants with Immune-related | Baseline until up to 90 days after end of treatment(up to approximately 46 months) and related biomarkers | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Duration of Progression-Free Survival as assessed by the Investigator using Recist v1.1 | Baseline until PD or death,whichever occurs first(up to approximately 23months)] | 
| Treatment related biomarkers | Biomarkers:CD 4+,CD28+,PD L1,TMB etc. | Baseline until PD or death,whichever occurs during this period(up to approximately 23months)] | 
| Quality of Life (QL) | QL as assessed by using EORTC | 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 | Baseline until PD or death,whichever occurs during this period(up to approximately 23months)] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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1L ES-SCLC