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This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC.
Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serplulimab + chemotherapy | Experimental | Serplulimab + chemotherapy (carboplatin-etoposide) |
|
| Atezolizumab + chemotherapy | Active Comparator | Atezolizumab + chemotherapy (carboplatin-etoposide) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab + chemotherapy (carboplatin-etoposide) | Drug | Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. Drug: carboplatin and etoposide chemotherapeutics |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall assessment | A period from randomization through death regardless of causality (approximately up to 24 months). |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | approximately up to 14 months |
| PFS | Progression-free survival | approximately up to 24 months |
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Inclusion Criteria:
Voluntary participation in clinical studies.
Male or female aged ≥ 18 years at the time of signing the ICF.
Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
No prior systemic therapy for ES-SCLC.
At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization.
Major organs are functioning well.
Every effort should be made to provide tumor tissues for the determination of PD-L1 expression.
An ECOG PS score of 0 or 1.
An expected survival ≥ 12 weeks.
Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment.
Participant must keep contraception.
Exclusion Criteria:
Histologically or cytologically confirmed mixed SCLC.
Known history of severe allergy to any monoclonal antibody.
Known hypersensitivity to carboplatin or etoposide.
Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia.
Pregnant or breastfeeding females.
Patients with a known history of psychotropic drug abuse or drug addiction.
Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | 35223 | United States | ||
| City of Hope - Phoenix |
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| Atezolizumab + chemotherapy (carboplatin-etoposide) | Drug | Drug: Atezolizumab is a monoclonal antibody targeting PD-L1,developed by Roche Pharma AG. Drug: carboplatin and etoposide chemotherapeutics |
|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Adverse events are described and graded using the grading categories defined in CTCAE, Version 5.0 | approximately up to 24 months |
| Maximum Plasma Concentration (Cmax) | The maximum concentration (Cmax) of Serplulimab will be measured | approximately up to 24 months |
| Minimum Plasma Concentration (Cmin) | The minimum concentration (Cmin) of Serplulimab will be measured | approximately up to 24 months |
| Average Plasma Concentration (Cavg) | The average Plasma Concentration (Cavg) of Serplulimab will be measured | approximately up to 24 months |
| Goodyear |
| Arizona |
| 85338 |
| United States |
| Arizona Clinical Research Center (ACRC) | Tucson | Arizona | 85715 | United States |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States |
| Compassionate Care Research Group | Fountain Valley | California | 92708 | United States |
| Providence Medical Foundation | Fullerton | California | 92835 | United States |
| Los Angeles Cancer Network | Glendale | California | 91204 | United States |
| OPN - Oncology Physician Network | Los Alamitos | California | 90720 | United States |
| Kaiser Permanente Research (Southern California) | Los Angeles | California | 90034 | United States |
| UC Davis | Sacramento | California | 95817 | United States |
| UCHealth Memorial Hospital North | Colorado Springs | Colorado | 80920 | United States |
| Banner MD Anderson Cancer Center (BMDACC) | Greeley | Colorado | 80631 | United States |
| MD Anderson- North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Advanced Cancer Treatment Centers | Brooksville | Florida | 34613 | United States |
| Cancer Specialists North Florida | Jacksonville | Florida | 32256 | United States |
| Mount Sinai Comprehensive Cancer Center | Miami | Florida | 33140 | United States |
| Florida Cancer Affiliates- (Ocala Oncology - Main) | Ocala | Florida | 34473 | United States |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | United States |
| BRCR Global | Plantation | Florida | 33322 | United States |
| Napa Research | Pompano Beach | Florida | 33064 | United States |
| Advanced Research | Tamarac | Florida | 33321 | United States |
| City of Hope- Chicago | Chicago | Illinois | 60099 | United States |
| Cancer Center of Decatur | Decatur | Illinois | 62526 | United States |
| Accellacare of Duly | Tinley Park | Illinois | 60487 | United States |
| Northwest Cancer Centers | Dyer | Indiana | 46311 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Pikeville Hospital | Pikeville | Kentucky | 41501 | United States |
| CHRISTUS St. Frances Cabrini Cancer Center | Alexandria | Louisiana | 71301 | United States |
| Pontchartrain Cancer Center | Hammond | Louisiana | 70433 | United States |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | United States |
| Henry Ford Health Providence Southfield Hospital | Southfield | Michigan | 48075 | United States |
| Health Partners Cancer Center at Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Hattiesburg Clinic Hematology/Oncology | Hattiesburg | Mississippi | 39401 | United States |
| North Mississippi Medical Center Hematology and Oncology Clinic | Tupelo | Mississippi | 38801 | United States |
| MidAmerica Division Inc., c/o Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Lake Regional | Osage Beach | Missouri | 65065 | United States |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59102 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68106 | United States |
| Renown Health | Reno | Nevada | 89502 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Regional Cancer Care Associates LLC RCCA | Freehold | New Jersey | 03756 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| Elmhurst (BRANY site) | Elmhurst | New York | 11373 | United States |
| Northwell Health | Lake Success | New York | 11042 | United States |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | United States |
| Great Lakes Cancer Care (Kaleida Health) | Williamsville | New York | 14221 | United States |
| Summa Health | Akron | Ohio | 44304 | United States |
| Cleveland Clinic Mercy Hospital | Canton | Ohio | 44708 | United States |
| Aultman Cancer Center | Canton | Ohio | 44710 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Tricounty Hematology and Oncology Associates | Massillon | Ohio | 44646 | United States |
| CharterCARE (Roger Williams) | Providence | Rhode Island | 02908 | United States |
| Monument Health | Rapid City | South Dakota | 57701 | United States |
| CHRISTUS Institute for Innovation & Advanced Clinical Care | Corpus Christi | Texas | 78404 | United States |
| DHR Research | Edinburg | Texas | 78539 | United States |
| Millennium Research and Clinical Development | Houston | Texas | 77090 | United States |
| Lumi Research | Kingwood | Texas | 77339 | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | United States |
| The University of Texas Health Science Center at Tyler/HOPE Cancer Center | Tyler | Texas | 75701 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| American Oncology Network Vista Oncology Division | Olympia | Washington | 98502 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| West Virginia University Cancer Institute | Morgantown | West Virginia | 26505 | United States |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
| Froedtert Hospital- Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| C098534 | EC regimen |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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