Real World Study of Efficacy and Safety of Atezolizumab Plus Chemotherapy in Chinese Patients With ES-SCLC
First-line Atezolizumab Plus Chemotherapy in Patients With Extensive-stage Small-cell Lung Cancer:a Real World,Single Arm,Multicenter,Prospective Study in China
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2020
CompletedFirst Submitted
Initial submission to the registry
December 4, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedDecember 11, 2020
December 1, 2020
6 months
December 4, 2020
December 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
PFS
Baseline until PD or death,whichever occurs first(up to approximately 23months)]
Treatment related biomarkers
Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
Quality of Life (QL)
Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
) Score
Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
Study Arms (2)
Arm A
200/Atezolizumab combined with EC regimen Atezolizumab:1200 mg Q3w
Arm B
100/Atezolizumab combined with chemotherapy Atezolizumab:1200mg Q3w
Interventions
Eligibility Criteria
This 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. People with ES-SCLC will be included in the study according to the eligibility criteria.
You may qualify if:
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system)
- No prior systemic treatment for ES-SCLC
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Union Medical College Hospitallead
- Beijing Hospitalcollaborator
- China-Japan Friendship Hospitalcollaborator
- Beijing Chest Hospitalcollaborator
- Beijing Chao Yang Hospitalcollaborator
Study Sites (1)
Peking union medical college hospital，
Beijing, Beijing Municipality, 110000, China
Related Publications (2)
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PMID: 21296855RESULTGovindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.
PMID: 17008692RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Zhang, PhD
Peking union medical college hospital,China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor,Chief physician
Study Record Dates
First Submitted
December 4, 2020
First Posted
December 11, 2020
Study Start
June 30, 2020
Primary Completion
December 30, 2020
Study Completion
May 30, 2021
Last Updated
December 11, 2020
Record last verified: 2020-12