To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05468489
• Other study ID #: ASTRIDE (HLX10-005-SCLC301-E)
• Status: Recruiting
• Phase: Phase 2
• Start date: November 18, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Shanghai Henlius Biotech
• Contact: Marshika Vickers
• Phone: 510-473-2872
• Email: marshika_vickers[@]henlius.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Serplulimab + chemotherapy (carboplatin-etoposide)
Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. Drug: carboplatin and etoposide chemotherapeutics
• Atezolizumab + chemotherapy (carboplatin-etoposide)
Drug: Atezolizumab is a monoclonal antibody targeting PD-L1,developed by Roche Pharma AG. Drug: carboplatin and etoposide chemotherapeutics

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

United States, 

Outcome

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