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)
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Thoracic (ONC)
Current Status: Open
Phase: II
Principal Investigator: Muir, Kate-Lynn
Contact Information:
Kellie Rinehart
kellie.rinehart@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06773910?term=NCT06773910&rank=1#participation-criteria
Summary
Primary
Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS). [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]
Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause.
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.]
Progression Free Survival (PFS) is defined as the time from start of study treatment to the date of an event, defined as the first documented radiological progression or death due to any cause.
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.]
Objective Response Rate (ORR) is defined as the proportion of participants with BOR of CR or PR according to RECIST v1.1.
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.]
Clinical Benefit Rate (CBR) is defined as the proportion of participants with BOR of CR or PR, or participants with SD lasting at least 180 days (i.e., ≥6 months) according to RECIST v1.1.
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.]
Disease Control Rate (DCR) is defined as the proportion of participants with BOR of CR, PR, or SD according to RECIST v1.1
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.]
Duration of Response (DoR) is defined as the duration from the first documented response (Complete Response (CR), Partial Response (PR), or Stable Disease (SD), according to RECIST v1.1) to the date of first documented disease progression or death.
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.]
Time to Progression (TtP) is defined as the time from the date of randomization to the date of first documented disease progression, according to RECIST v1.1.
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.]
Time to development of central nervous system (CNS) metastasis is defined as the time from the date of randomization to the date of first documented CNS metastasis.
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.]
Adverse Events to be evaluated per CTCAE v5.0 criteria from first dose of BMS-986489 to 100 days after the last dose of BMS-986489.