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.
Being voluntary to sign the informed consent form, with good compliance with the study treatment regimen and visit schedule.
Men or women ≥18 years of age.
Histologically or cytologically confirmed SCLC.
Life expectancy ≥12 weeks.
Patients with central nervous system (CNS) metastases, unless that they have received corresponding treatment and have been shown by a repeated imaging examination to have stable disease (i.e., no evidence of disease progression) for at least 4 weeks (Note: the repeated imaging examination should be performed at screening), are asymptomatic, and do not need to receive steroid therapy within at least 7 days prior to the first dose of the investigational medicinal product.
Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
Prior use of Lurbinectedin, Trabectedin, PM14 (Ecubebectedin), or topoisomerase I inhibitors (Irinotecan, Topotecan, etc.).
Having received a strong or moderate CYP3A4 inhibitor within 2 weeks prior to the first dose of the investigational medicinal product (see Appendix III for details).
Parallel
Lurbinectedin
DrugLurbinectedin 3.2 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)
Irinotecan
DrugIrinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk
Lurbinectedin
DrugLurbinectedin 2.0 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)
Topotecan
DrugTopotecan 1.2 mg/m² intravenously Days 1-5 q3wk
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)
Progression-free survival by IRC (Independent Review Committee)
Progression-free survival by IA (Investigator Assessment)
Overall response rate by IRC
Overall response rate by IA
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
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
Progression-free survival rate at 6 months by IRC
Progression-free survival rate at 6 months by IA
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