Extensive Stage Small Cell Lung Cancer Clinical Trial
Official title:
A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)
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: - Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) - Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2025 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Summa Health | Akron | Ohio |
United States | CHRISTUS St. Frances Cabrini Cancer Center | Alexandria | Louisiana |
United States | OPN - Oncology Physician Network | Arcadia | California |
United States | Sandra and Malcolm Berman Cancer Institute at Greater Baltimore Medical Center | Baltimore | Maryland |
United States | American Oncology Partners of Maryland, PA | Bethesda | Maryland |
United States | St. Vincent Frontier Cancer Center | Billings | Montana |
United States | O'Neal Comprehensive Cancer Center | Birmingham | Alabama |
United States | Advanced Cancer Treatment Centers | Brooksville | Florida |
United States | Lahey Hospital & Medical Center | Burlington | Massachusetts |
United States | Aultman Cancer Center | Canton | Ohio |
United States | Cleveland Clinic Mercy Hospital | Canton | Ohio |
United States | Gabrail Cancer Center (GCC) Research- Canton Facility | Canton | Ohio |
United States | City of Hope- Chicago | Chicago | Illinois |
United States | MetroHealth | Cleveland | Ohio |
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
United States | UCHealth Memorial Hospital North | Colorado Springs | Colorado |
United States | CHRISTUS Institute for Innovation & Advanced Clinical Care | Corpus Christi | Texas |
United States | Pontchartrain Cancer Center | Covington | Louisiana |
United States | Cancer Center of Decatur | Decatur | Illinois |
United States | Saint Joseph Hospital | Denver | Colorado |
United States | DHR Research | Edinburg | Texas |
United States | Elmhurst (BRANY site) | Elmhurst | New York |
United States | NorthShore University Health System | Evanston | Illinois |
United States | Summit Medical Group | Florham Park | New Jersey |
United States | The Center for Cancer and Blood Disorders | Fort Worth | Texas |
United States | Compassionate Care Research Group | Fountain Valley | California |
United States | Regional Cancer Care Associates LLC RCCA | Freehold | New Jersey |
United States | Providence Medical Foundation | Fullerton | California |
United States | Los Angeles Cancer Network | Glendale | California |
United States | Lutheran Medical Cancer Center | Golden | Colorado |
United States | City of Hope - Phoenix | Goodyear | Arizona |
United States | Pontchartrain Cancer Center | Hammond | Louisiana |
United States | Valley Cancer Associates | Harlingen | Texas |
United States | Hattiesburg Clinic Hematology/Oncology | Hattiesburg | Mississippi |
United States | Millennium Research and Clinical Development | Houston | Texas |
United States | MidAmerica Division Inc., c/o Research Medical Center | Kansas City | Missouri |
United States | Lumi Research | Kingwood | Texas |
United States | Northwell Health | Lake Success | New York |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Baptist Health Lexington | Lexington | Kentucky |
United States | Cancer Partners of Nebraska | Lincoln | Nebraska |
United States | Long Beach Memorial Medical Center | Long Beach | California |
United States | OPN - Oncology Physician Network | Los Alamitos | California |
United States | California Research Institute | Los Angeles | California |
United States | Kaiser Permanente Research (Southern California) | Los Angeles | California |
United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
United States | Tricounty Hematology and Oncology Associates | Massillon | Ohio |
United States | Mount Sinai Comprehensive Cancer Center | Miami | Florida |
United States | United Medical Group | Miami | Florida |
United States | Froedtert Hospital- Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | West Virginia University Cancer Institute | Morgantown | West Virginia |
United States | Tulane Medical Center | New Orleans | Louisiana |
United States | Florida Cancer Affiliates- (Ocala Oncology - Main) | Ocala | Florida |
United States | American Oncology Network Vista Oncology Division | Olympia | Washington |
United States | Nebraska Methodist Hospital | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Mid Florida Hematology and Oncology Center | Orange City | Florida |
United States | BRCR Global | Plantation | Florida |
United States | Napa Research | Pompano Beach | Florida |
United States | CharterCARE (Roger Williams) | Providence | Rhode Island |
United States | Renown Health | Reno | Nevada |
United States | Northwest Oncology and Hematology | Rolling Meadows | Illinois |
United States | UC Davis | Sacramento | California |
United States | Health Partners Cancer Center at Regions Hospital | Saint Paul | Minnesota |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | Utah Cancer Specialists | Salt Lake City | Utah |
United States | CHRISTUS St. Vincent | Santa Fe | New Mexico |
United States | Providence Medical Group | Santa Rosa | California |
United States | Willis-Knighton Cancer Center | Shreveport | Louisiana |
United States | Ascension Providence Hospital CK Potluri Cancer Center | Southfield | Michigan |
United States | Medical Oncology Associates, PS (dba Summit Cancer Centers) | Spokane Valley | Washington |
United States | Highlands Oncology Group | Springdale | Arkansas |
United States | Oncology Hematology Associates | Springfield | Missouri |
United States | The Stamford Hospital | Stamford | Connecticut |
United States | Stony Brook Cancer Center | Stony Brook | New York |
United States | Northwest Medical Specialties, PLLC | Tacoma | Washington |
United States | Advanced Research | Tamarac | Florida |
United States | Accellacare of Duly | Tinley Park | Illinois |
United States | The Toledo Clinic | Toledo | Ohio |
United States | North Mississippi Medical Center Hematology and Oncology Clinic | Tupelo | Mississippi |
United States | The University of Texas Health Science Center at Tyler/HOPE Cancer Center | Tyler | Texas |
United States | Cancer Center of Kansas | Wichita | Kansas |
United States | Great Lakes Cancer Care (Kaleida Health) | Williamsville | New York |
Lead Sponsor | Collaborator |
---|---|
Shanghai Henlius Biotech |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | OS | Overall assessment | A period from randomization through death regardless of causality (approximately up to 24 months). | |
Secondary | ORR | Objective response rate | approximately up to 14 months | |
Secondary | PFS | Progression-free survival | approximately up to 24 months | |
Secondary | 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 | |
Secondary | Maximum Plasma Concentration (Cmax) | The maximum concentration (Cmax) of Serplulimab will be measured | approximately up to 24 months | |
Secondary | Minimum Plasma Concentration (Cmin) | The minimum concentration (Cmin) of Serplulimab will be measured | approximately up to 24 months | |
Secondary | Average Plasma Concentration (Cavg) | The average Plasma Concentration (Cavg) of Serplulimab will be measured | approximately up to 24 months |
Status | Clinical Trial | Phase | |
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