An Open-label, Randomized Study of BMS-986489 (Atigotatug + Nivolumab Fixed-dose Combination) vs Durvalumab as Consolidation Therapy Following Chemoradiotherapy in Limited-stage Small-cell Lung Cancer (TIGOS-LS)
Summary
This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab in limited-stage (LS)-small-cell lung cancer (SCLC) participants. The main goals of this study are to: * Evaluate the efficacy of BMS-986489 vs durvalumab * Evaluate the safety profile of BMS-986489
Detailed description
This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab as consolidation therapy following chemoradiotherapy in participants with limited-stage (LS)-small-cell lung cancer (SCLC). Participants will receive concurrent chemotherapy and radiotherapy according to standard guidelines for treatment of LS-SCLC without progressive disease prior to randomization. Eligible participants will be randomly assigned to receive either BMS-986489 (atigotatug + nivolumab as a fixed-dose combination; Arm A) or durvalumab (Arm B) as consolidation therapy. Atigotatug is a first-in-class, fully human IgG1 antibody being developed for the treatment of SCLC. Atigotatug specifically binds to fuc-GM1 on the tumor cell. Nivolumab is a monoclonal anti-PD-1 antibody. Combining atigotatug with another immunotherapy may provide enhanced antitumor effects.
Arms & interventions
- DrugBMS-986489
BMS-986489 (fixed dose combination of atigotatug + nivolumab) will be administered as an intravenous infusion to be given once every 4 weeks for up to 2 years.
- DrugDurvalumab
Durvalumab will be administered as a fixed dose intravenous infusion to be given once every 4 weeks for up to 2 years.
Outcome measures
Primary
Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS).
Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause.
Time frame: From date of randomization up to 5 years. Every 8 weeks for participants who stopped treatment before disease progression and before completing 6 months of treatment and every 12 weeks for participants who stopped treatment before disease progression and
Secondary
Evaluate the efficacy of BMS-986489 vs durvalumab by Progression Free Survival (PFS).
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab Objective Response Rate (ORR).
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Clinical Benefit Rate (CBR).
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Disease Control Rate (DCR).
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Duration of Response (DoR).
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Time to Progression (TtP).
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by time to development of central nervous system (CNS) metastasis.
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the number of participants with adverse events following administration of BMS-986489.
Time frame: From Cycle 1 Day 1 to 100 days after the last dose of BMS-986489. Each cycle is 28 days.
Eligibility criteria
Study locations (33)
Southern Cancer Center
Daphne, Alabama, 36526
Sansum Clinic
Santa Barbara, California, 93105
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
University of Miami - Sylvester Cancer Center
Miami, Florida, 33136
Ocala Oncology Center
Ocala, Florida, 34474
Florida Cancer Specialists - North
Orange City, Florida, 32763
Cancer Care Centers of Brevard
Palm Bay, Florida, 32901
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401
Piedmont Healthcare - Atlanta
Atlanta, Georgia, 30309
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Illinois Cancer Care
Peoria, Illinois, 61615
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Baptist Health - Corbin
Corbin, Kentucky, 40701
Baptist Health - Lexington
Lexington, Kentucky, 40503
Baptist Health - Louisville
Louisville, Kentucky, 40207
Minnesota Oncology Hematology
Maple Grove, Minnesota, 55369
Missouri Cancer Associates
Columbia, Missouri, 65201
White Plains Hospital Physician Associates
White Plains, New York, 10601
Carolina Cancer Research Center
Wilson, North Carolina, 27896
Oncology Hematology Care
Cincinnati, Ohio, 45242
Mid Ohio Hem/ Onc dba The Mark H Zangmeister Center
Columbus, Ohio, 43219
Oncology Associates of Oregon (Willamette Valley Cancer Institute and Research Center)
Eugene, Oregon, 97401
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
SCRI Oncology Partners
Nashville, Tennessee, 37203
Texas Oncology - West Texas
Amarillo, Texas, 79124
Texas Oncology- Austin
Austin, Texas, 78705
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702
Texas Oncology - DFW
Dallas, Texas, 75246
Texas Oncology - Northeast Texas
Denison, Texas, 75020
Texas Oncology - San Antonio
San Antonio, Texas, 78240
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Virginia Oncology Associates
Norfolk, Virginia, 23502
Blue Ridge Cancer Center (Oncology & Hematology Associates of Southwest VA)
Salem, Virginia, 24153