Status:
UNKNOWN
Real World Study of Efficacy and Safety of Atezolizumab Plus Chemotherapy in Chinese Patients With ES-SCLC
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing Hospital
China-Japan Friendship Hospital
Conditions:
Extensive-stage Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
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 als...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04663438
Start Date
June 30 2020
End Date
May 30 2021
Last Update
December 11 2020
Active Locations (1)
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1
Peking union medical college hospital，
Beijing, Beijing Municipality, China, 110000