Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
| China-Japan Friendship Hospital | OTHER |
| Beijing Chest Hospital | OTHER |
| Beijing Chao Yang Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | 200/Atezolizumab combined with EC regimen Atezolizumab:1200 mg Q3w |
| |
| Arm B | 100/Atezolizumab combined with chemotherapy Atezolizumab:1200mg Q3w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy Drugs, Cancer | Drug | Other chemotherapy:Irinotecan;topotecan;Enrotinib;Bevacil |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)] |
| Treatment related biomarkers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, PhD | Contact | 16601139836 | pumchzhangli@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, PhD | Peking union medical college hospital,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking union medical college hospital, | Recruiting | Beijing | Beijing Municipality | 110000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21296855 | Result | 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. | |
| 17008692 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000970 | Antineoplastic Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Biomarkers:CD 4+,CD28+,PD L1,TMB etc.
| Baseline until PD or death,whichever occurs during this period(up to approximately 23months)] |
| Quality of Life (QL) | QL as assessed by using EORTC | Baseline until PD or death,whichever occurs during this period(up to approximately 23months)] |
| ) 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)] |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |