Lurbinectedin or in Combination With Irinotecan Versus Topotecan in Patients With Relapsed SCLC
NCT Number: NCT06496048
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Relapsed Small Cell Lung Cancer
Interventions: DRUG: Lurbinectedin|DRUG: Irinotecan|DRUG: Lurbinectedin|DRUG: Topotecan
Sponsor: Luye Pharma Group Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2028-06-30

Summary:
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

Primary Outcome Measures: Overall survival (OS), OS will be calculated calculated from the date of randomization until the date of death or the last contact date (in which case, OS time will be censored at that date), from the date of randomization until the date of death or the last contact date, up to 12 months after randomization of the last enrolled subject
Secondary Outcome Measures: Progression-free survival by IRC (Independent Review Committee), Time Frame: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 12 months after randomization of the last enrolled subject|Progression-free survival by IA (Investigator Assessment), Time Frame: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 12 months after randomization of the last enrolled subject|Overall response rate by IRC, From the date of randomization to the date of death or the date of progressive disease, up to 12 months after randomization of the last enrolled subject|Overall response rate by IA, From the date of randomization to the date of death or the date of progressive disease, up to 12 months after randomization of the last enrolled subject
Other Outcome Measures: Overall survival rate at 12 month, Overall survival rate at 12 months is defined as the percentage of people who are still alive at 12 months after randomization, At 12 months|Overall survival rate at 24 months, Overall survival rate at 24 months is defined as the percentage of people who are still alive at 24 months after randomization, At 24 months|Progression-free survival rate at 6 months by IRC, At 6 months|Progression-free survival rate at 6 months by IA, At 6 months|Progression-free survival rate at 12 months by IRC, At 12 months|Progression-free survival rate at 12 months by IA, At 12 months|Duration of response by IRC, From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 12 months after randomization of the last enrolled subject|Duration of response by IA, From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 12 months after randomization of the last enrolled subject|Patient-reported outcomes, At baseline and every six weeks (± one week) until end of treatment, up to 12 months after randomization of the last enrolled subject