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

Extensive-stage Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04663438
• Other study ID #: ZS-2407
• Status: Recruiting
• Start date: June 30, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: December 2020
• Source: Peking Union Medical College Hospital
• Contact: Li Zhang, PhD
• Phone: 16601139836
• Email: pumchzhangli[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 30, 2021
• Est. primary completion date: December 30, 2020
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Extensive-stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Chemotherapy Drugs, Cancer
Other chemotherapy:Irinotecan;topotecan;Enrotinib;Bevacil

Locations

Country	Name	City	State
China	Peking union medical college hospital,	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Chao Yang Hospital, Beijing Chest Hospital, Beijing Hospital, China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Govindan 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 data — View Citation

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. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	Duration of overall survival	Baseline until death from any cause(up to approximately 23 months)
Primary	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	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)]
Secondary	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)]
Secondary	Quality of Life (QL)	QL as assessed by using EORTC	Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
Secondary	) 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)]