A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
- Conditions
- Small-Cell Lung Cancer
- Interventions
- Registration Number
- NCT05091567
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 660
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Atezolizumab+Lurbinectedin Carboplatin Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle. Arm A: Atezolizumab+Lurbinectedin Atezolizumab Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle. Arm A: Atezolizumab+Lurbinectedin Lurbinectedin Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle. Arm A: Atezolizumab+Lurbinectedin Etoposide Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle. Arm B: Atezolizumab Atezolizumab Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle. Arm B: Atezolizumab Carboplatin Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle. Arm B: Atezolizumab Etoposide Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Randomization to the date of death from any cause (up to approximately 60 months) Overall survival (OS) is defined as the time from randomization to the date of death from any cause.
IRF-Assessed Progression-Free Survival (PFS) Randomization to the date of first documented disease progression or death, whichever occurs first (up to approximately 60 months) IRF-assessed progression-free survival (PFS) is defined as the time from randomization to the date of first documented disease progression (as assessed by the IRF according to RECIST v1.1), or death whichever occurs first.
- Secondary Outcome Measures
Name Time Method Investigator-Assessed PFS Randomization to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to approximately 60 months) Investigator-assessed PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).
Confirmed Objective Response Rate (ORR) as Determined by the IRF Up to approximately 60 months Confirmed objective response rate (ORR) is defined as the proportion of randomized participants with a CR or PR on two consecutive occasions \>= 4 weeks apart after randomization, as determined by the IRF according to RECIST v1.1.
Confirmed Objective Response Rate (ORR) as Determined by the Investigator Up to approximately 60 months Confirmed objective response rate (ORR) is defined as the proportion of randomized participants with a CR or PR on two consecutive occasions \>= 4 weeks apart after randomization, as determined by the Investigator according to RECIST v1.1.
Duration of Response (DOR) as Determined by the IRF Up to approximately 60 months Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response after randomization until disease progression as determined by the IRF according to RECIST v1.1, or death from any cause, whichever occurs first.
Duration of Response (DOR) as Determined by the Investigator Up to approximately 60 months Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response after randomization until disease progression as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first.
PFS Rates as Determined by the IRF 6 months and 12 months after randomization PFS rates at 6 months and 12 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months and 12 months after randomization, as determined by the IRF according to RECIST v1.1.
PFS Rates as Determined by the Investigator 6 months and 12 months after randomization PFS rates at 6 months and 12 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months and 12 months after randomization, as determined by the investigator according to RECIST v1.1.
Time to Confirmed Deterioration (TTCD) Up to approximately 60 months Time to confirmed deterioration (TTCD) from randomization in participant-reported physical functioning and global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30).
OS Rates 12 months and 24 months after randomization OS rates at 12 months and 24 months is defined as the proportion of participants who have not experienced death from any cause at 12 months and 24 months after randomization.
Percentage of Participants With Adverse Events Up to approximately 60 months Percentage of participants with adverse events.
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab Up to approximately 60 months Percentage of participants with ADAs to atezolizumab after drug administration.
Trial Locations
- Locations (92)
The Mark H. Zangmeister Ctr
🇺🇸Columbus, Ohio, United States
Fachklinik für Lungenerkrankungen
🇩🇪Immenhausen, Germany
Florida Cancer Specialists
🇺🇸West Palm Beach, Florida, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
🇺🇸Marietta, Georgia, United States
Illinois Cancer Care
🇺🇸Peoria, Illinois, United States
New England Cancer Specialists
🇺🇸Scarborough, Maine, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cancer & Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Mercy Research - St. Louis
🇺🇸St Louis, Missouri, United States
Clinical Research Alliance
🇺🇸Westbury, New York, United States
Scroll for more (82 remaining)The Mark H. Zangmeister Ctr🇺🇸Columbus, Ohio, United States