A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy
Summary
The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy. Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.
Arms & interventions
- DrugTifcemalimab injection
200mg once every 3weeks
- Drugtoripalimab injection
240mg once every 3 weeks
- DrugPlacebo for Tifcemalimab
every 3weeks
- DrugPlacebo for toripalimab
every 3weeks
Outcome measures
Primary
Overall survival (OS)
To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after chemoradiotherapy (CRT) for patients with LS-SCLC as measured by OS
Time frame: up to 3years
OS
To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by OS"
Time frame: up to 3years
Progression-free survival (PFS)
To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by Blinded Independent Review Committee (BIRC)-assessed PFS.
Time frame: up to 2years
Progression-free survival (PFS)
To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by OS and BIRC-assessed PFS.
Time frame: up to 2years
Secondary
PFS
Time frame: up to 2years
1-year OS rate
Time frame: up to 1year
2-year OS rate
Time frame: up to 2 years
objective response rate (ORR)
Time frame: up to 2 years
disease control rate (DCR)
Time frame: up to 2 years
duration of response (DoR)
Time frame: up to 2years
PFS
Time frame: up to 2 years
1 year OS rate
Time frame: up to 1 years
2 year OS rate
Time frame: up to 2 years
ORR
Time frame: up to 2 years
DCR
Time frame: up to 2 years
DoR
Time frame: up to 2 years
safety
Time frame: up to 2 years
safety
Time frame: up to 2 years
Eligibility criteria
Study locations (29)
Banner MD Anderson Cancer Center
Goodyear, Arizona, 85338
Banner University Medical Center
Tucson, Arizona, 85713
Genesis Cancer and Blood Institute (Hot Springs, AR)
Hot Springs, Arkansas, 05001
SCRI Nashville
Davis, California, 95616
Zangmeister Cancer Center (Columbus, OH)
Los Angeles, California, 43219
Los Angeles Hematology Oncology
Los Angeles, California, 90033
University of Southern California Norris Comprehensive Cancer
Los Angeles, California, 90033
Florida Cancer Specialists Pan Handle
Fort Myers, Florida, 32310
Florida Cancer Specialists South
Fort Myers, Florida, 33908
USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N
Miami, Florida, 33173
Mid-Florida Hematology Oncology
Orange City, Florida, 55905
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
Norton Cancer Institute, Downtown, Multidisciplinary Clinic
Louisville, Kentucky, 40241
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
Dana Farber Cancer Institute-Hematology/Oncology
Boston, Massachusetts, 461099
Karmanos Cancer Center
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49502
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63101
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 07101
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
New York, New York, 11776
University of Stony Brook
Stony Brook, New York, 11794
Toledo Clinic Cancer Center - Toledo
Toledo, Ohio, 97391
Oncology Associates Of Oregon, P.C.
Eugene, Oregon, 97401
Oregon Health and Science University
Portland, Oregon, 97239
Millennium Physicians - Oncology
Houston, Texas, 77090
Texas Oncology, P.A. - Oncology
Tyler, Texas, 97402
Virginia Cancer Specialists
Fairfax, Virginia, 22030