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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Unknown

Conditions

Extensive-stage Small Cell Lung Cancer

Treatments

Drug: Chemotherapy Drugs, Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04663438

ZS-2407

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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