Clinical trial NCT05468489: To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Extensive Stage Small Cell Lung Cancer
Keywords: Extensive Stage Small Cell Lung Cancer
Anti-PD-1 Monoclonal Antibody
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2022-07-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: 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.

Primary outcomes:
measure: OS
timeFrame: A period from randomization through death regardless of causality (approximately up to 24 months).
Secondary outcomes:
measure: ORR
timeFrame: approximately up to 14 months
measure: PFS
timeFrame: approximately up to 24 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: approximately up to 24 months
measure: Maximum Plasma Concentration (Cmax)
timeFrame: approximately up to 24 months
measure: Minimum Plasma Concentration (Cmin)
timeFrame: approximately up to 24 months
measure: Average Plasma Concentration (Cavg)
timeFrame: approximately up to 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Birmingham
country: United States
facility: O'Neal Comprehensive Cancer Center
state: Alabama
city: Goodyear
country: United States
facility: City of Hope - Phoenix
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center (ACRC)
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Arcadia
country: United States
facility: OPN - Oncology Physician Network
state: California
city: Fountain Valley
country: United States
facility: Compassionate Care Research Group
state: California
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: Glendale
country: United States
facility: Los Angeles Cancer Network
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Los Alamitos
country: United States
facility: OPN - Oncology Physician Network
state: California
city: Los Angeles
country: United States
facility: California Research Institute
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Research (Southern California)
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Group
state: California
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital North
state: Colorado
city: Denver
country: United States
facility: Saint Joseph Hospital
state: Colorado
city: Golden
country: United States
facility: Lutheran Medical Cancer Center
state: Colorado
city: Greeley
country: United States
facility: Banner MD Anderson Cancer Center (BMDACC)
state: Colorado
city: Greeley
country: United States
facility: MD Anderson- North Colorado Medical Center
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Associates
state: Connecticut
city: Stamford
country: United States
facility: The Stamford Hospital
state: Connecticut
city: Brooksville
country: United States
facility: Advanced Cancer Treatment Centers
state: Florida
city: Clermont
country: United States
facility: Clermont Oncology Center
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists North Florida
state: Florida
city: Miami
country: United States
facility: United Medical Group
state: Florida
city: Miami
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Ocala
country: United States
facility: Florida Cancer Affiliates- (Ocala Oncology - Main)
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center
state: Florida
city: Plantation
country: United States
facility: BRCR Global
state: Florida
city: Pompano Beach
country: United States
facility: Napa Research
state: Florida
city: Tamarac
country: United States
facility: Advanced Research
state: Florida
city: Chicago
country: United States
facility: City of Hope- Chicago
state: Illinois
city: Decatur
country: United States
facility: Cancer Center of Decatur
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Rolling Meadows
country: United States
facility: Northwest Oncology and Hematology
state: Illinois
city: Tinley Park
country: United States
facility: Accellacare of Duly
state: Illinois
city: Dyer
country: United States
facility: Northwest Cancer Centers
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare - Norton Cancer Institute - Downtown Women's Cancer Center
state: Kentucky
city: Pikeville
country: United States
facility: Pikeville Hospital
state: Kentucky
city: Alexandria
country: United States
facility: CHRISTUS St. Frances Cabrini Cancer Center
state: Louisiana
city: Covington
country: United States
facility: Pontchartrain Cancer Center
state: Louisiana
city: Hammond
country: United States
facility: Pontchartrain Cancer Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Cancer Center
state: Louisiana
city: Baltimore
country: United States
facility: Sandra and Malcolm Berman Cancer Institute at Greater Baltimore Medical Center
state: Maryland
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland, PA
state: Maryland
city: Boston
country: United States
facility: Tufts Medicine
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Southfield
country: United States
facility: Henry Ford Health Providence Southfield Hospital
state: Michigan
city: Saint Paul
country: United States
facility: Health Partners Cancer Center at Regions Hospital
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Center Hematology and Oncology Clinic
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Hospital Cancer Institute
state: Missouri
city: Kansas City
country: United States
facility: MidAmerica Division Inc., c/o Research Medical Center
state: Missouri
city: Osage Beach
country: United States
facility: Lake Regional
state: Missouri
city: Springfield
country: United States
facility: Oncology Hematology Associates
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Lincoln
country: United States
facility: Cancer Partners of Nebraska
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Reno
country: United States
facility: Renown Health
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Freehold
country: United States
facility: Regional Cancer Care Associates LLC RCCA
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Santa Fe
country: United States
facility: CHRISTUS St. Vincent
state: New Mexico
city: Elmhurst
country: United States
facility: Elmhurst (BRANY site)
state: New York
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
city: Williamsville
country: United States
facility: Great Lakes Cancer Care (Kaleida Health)
state: New York
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Canton
country: United States
facility: Cleveland Clinic Mercy Hospital
state: Ohio
city: Canton
country: United States
facility: Aultman Cancer Center
state: Ohio
city: Canton
country: United States
facility: Gabrail Cancer Center (GCC) Research- Canton Facility
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Massillon
country: United States
facility: Tricounty Hematology and Oncology Associates
state: Ohio
city: Toledo
country: United States
facility: The Toledo Clinic
state: Ohio
city: Providence
country: United States
facility: CharterCARE (Roger Williams)
state: Rhode Island
city: Rapid City
country: United States
facility: Monument Health
state: South Dakota
city: Corpus Christi
country: United States
facility: CHRISTUS Institute for Innovation & Advanced Clinical Care
state: Texas
city: Edinburg
country: United States
facility: DHR Research
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Harlingen
country: United States
facility: Valley Cancer Associates
state: Texas
city: Houston
country: United States
facility: Millennium Research and Clinical Development
state: Texas
city: Kingwood
country: United States
facility: Lumi Research
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler/HOPE Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Olympia
country: United States
facility: American Oncology Network Vista Oncology Division
state: Washington
city: Spokane Valley
country: United States
facility: Medical Oncology Associates, PS (dba Summit Cancer Centers)
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Cancer Institute
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital- Medical College of Wisconsin
state: Wisconsin
Study officials:
References: