Real World Study of Efficacy and Safety of Atezolizumab Plus Chemotherapy in Chinese Patients With ES-SCLC
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Interventions
- Drug: Chemotherapy Drugs, Cancer
- Registration Number
- NCT04663438
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm A Chemotherapy Drugs, Cancer 200/Atezolizumab combined with EC regimen Atezolizumab:1200 mg Q3w Arm B Chemotherapy Drugs, Cancer 100/Atezolizumab combined with chemotherapy Atezolizumab:1200mg Q3w
- Primary Outcome Measures
Name Time Method OS Baseline until death from any cause(up to approximately 23 months) Duration of overall survival
irAE Baseline until up to 90 days after end of treatment(up to approximately 46 months) and related biomarkers Percentage of participants with Immune-related
- Secondary Outcome Measures
Name Time Method PFS Baseline until PD or death,whichever occurs first(up to approximately 23months)] Duration of Progression-Free Survival as assessed by the Investigator using Recist v1.1
Treatment related biomarkers Baseline until PD or death,whichever occurs during this period(up to approximately 23months)] Biomarkers:CD 4+,CD28+,PD L1,TMB etc.
Quality of Life (QL) Baseline until PD or death,whichever occurs during this period(up to approximately 23months)] QL as assessed by using EORTC
) Score Baseline until PD or death,whichever occurs during this period(up to approximately 23months)] QLQ C30 Score and EORTC QLQ Lung cancer module (LC13)Score
Trial Locations
- Locations (1)
Peking union medical college hospital，
🇨🇳Beijing, Beijing, China