Clinical trial NCT04663438: Real World Study of Efficacy and Safety of Atezolizumab Plus Chemotherapy in Chinese Patients With ES-SCLC
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Extensive-stage Small Cell Lung Cancer
Keywords: 1L ES-SCLC
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
name: China-Japan Friendship Hospital
name: Beijing Chest Hospital
name: Beijing Chao Yang Hospital
First posted: 2020-12-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: OS
timeFrame: Baseline until death from any cause(up to approximately 23 months)
measure: irAE
timeFrame: Baseline until up to 90 days after end of treatment(up to approximately 46 months) and related biomarkers
Secondary outcomes:
measure: PFS
timeFrame: Baseline until PD or death,whichever occurs first(up to approximately 23months)]
measure: Treatment related biomarkers
timeFrame: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
measure: Quality of Life (QL)
timeFrame: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
measure: ) Score
timeFrame: Baseline until PD or death,whichever occurs during this period(up to approximately 23months)]
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital，
state: Beijing
Study officials:
affiliation: Peking union medical college hospital,China
name: Li Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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 database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.