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

Save

Report Abuse

Description

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)

Study Overview

Start Date
November 18, 2022
Completion Date
December 31, 2025
Enrollment
200
Date Posted
July 21, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
City of Hope - Phoenix
Goodyear, Arizona 85338, United States

Highlands Oncology Group
Springdale, Arkansas 72762, United States

OPN - Oncology Physician Network
Arcadia, California 91107, United States

Compassionate Care Research Group
Fountain Valley, California 92708, United States

Long Beach Memorial Medical Center
Long Beach, California 90806, United States

OPN - Oncology Physician Network
Los Alamitos, California 90720, United States

California Research Institute
Los Angeles, California 90027, United States

Kaiser Permanente Research (Southern California)
Los Angeles, California 90034, United States

Providence Medical Group
Santa Rosa, California 95403, United States

UCHealth Memorial Hospital North
Colorado Springs, Colorado 80920, United States

Lutheran Medical Cancer Center
Golden, Colorado 80401, United States

The Stamford Hospital
Stamford, Connecticut 06904, United States

Advanced Cancer Treatment Centers
Brooksville, Florida 34613, United States

United Medical Group
Miami, Florida 33135, 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

Northwest Oncology and Hematology
Rolling Meadows, Illinois 60008, United States

Cancer Center of Kansas
Wichita, Kansas 67214, United States

CHRISTUS St. Frances Cabrini Cancer Center
Alexandria, Louisiana 71301, United States

Pontchartrain Cancer Center
Covington, Louisiana 70433, United States

Pontchartrain Cancer Center
Hammond, Louisiana 70433, United States

Tulane Medical Center
New Orleans, Louisiana 70112, United States

Sandra and Malcolm Berman Cancer Institute at Greater Baltimore Medical Center
Baltimore, Maryland 21204, United States

American Oncology Partners of Maryland, PA
Bethesda, Maryland 20817, United States

Lahey Hospital & Medical Center
Burlington, Massachusetts 01805, United States

Ascension Providence Hospital CK Potluri Cancer Center
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

Oncology Hematology Associates
Springfield, Missouri 65807, United States

St. Vincent Frontier Cancer Center
Billings, Montana 59102, United States

Cancer Partners of Nebraska
Lincoln, Nebraska 68510, United States

Nebraska Methodist Hospital
Omaha, Nebraska 68114, United States

Renown Health
Reno, Nevada 89502, United States

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756, United States

Summit Medical Group
Florham Park, New Jersey 07932, United States

Regional Cancer Care Associates LLC RCCA
Freehold, New Jersey 03756, United States

CHRISTUS St. Vincent
Santa Fe, New Mexico 87505, United States

Elmhurst (BRANY site)
Elmhurst, New York 11373, 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

Gabrail Cancer Center (GCC) Research- Canton Facility
Canton, Ohio 44718, United States

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106, United States

Tricounty Hematology and Oncology Associates
Massillon, Ohio 44646, United States

The Toledo Clinic
Toledo, Ohio 43623, United States

CHRISTUS Institute for Innovation & Advanced Clinical Care
Corpus Christi, Texas 78404, United States

DHR Research
Edinburg, Texas 78539, United States

The Center for Cancer and Blood Disorders
Fort Worth, Texas 76104, United States

Valley Cancer Associates
Harlingen, Texas 78550, 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
Bountiful, Utah 84010, United States

American Oncology Network Vista Oncology Division
Olympia, Washington 98502, United States

Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane Valley, Washington 99216, 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

Eligibility

Minimum Age (years)
18
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.

Study Contact Info

Study Contact Name
Marshika Vickers
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC 0 reviews

Write Your Review

There are no reviews yet.

Write Your Review

Your email address will not be published. Required fields are marked *

Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
NCTid (if applicable)
NCT05468489