A Phase III, Multicenter, Randomized, Open-label Study of Lurbinectedin As Monotherapy or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed Small-cell Lung Cancer (SCLC)
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.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2 (see Appendix I for the scoring criteria).
• One prior line of etoposide + platinum chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of the patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)
• Chemotherapy-free interval (CTFI, i.e., the time from the last dose of first-line platinum-based chemotherapy to the occurrence of disease progression) ≥30 days.
• At least one measurable lesion (in accordance with RECIST 1.1 criteria).
• Adequate organ function as defined below:
∙ Hemoglobin ≥ 9.0 g/dL (Red blood cell transfusion is allowed to be given more than 2 weeks prior to enrollment if blood transfusion is clinically indicated); absolute neutrophil count ≥ 2.0 × 109/L, and platelet count ≥ 100 × 109/L.
‣ Alanine aminotransferase and aspartate aminotransferase ≤ 3.0 × ULN.
‣ Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ 1 × ULN.
‣ Albumin ≥ 3.0 g/dL.
‣ Calculated creatinine clearance (CrCL) ≥ 40 mL/min (using the Cockcroft-Gault formula, as detailed in Appendix IV).
⁃ ≥ 3 weeks since the last anti-tumor therapy and recovery of adverse events (AEs) related to prior anti-tumor therapy to Grade ≤ 1, as judged by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) (Except for anemia; and recovery to Grade ≤ 2 for sensory neuropathy, asthenia and alopecia).
⁃ Female patients of childbearing potential must have a negative blood or urine pregnancy test prior to enrollment, and must accept to take highly effective contraceptive measures during the treatment with the investigational medicinal product and for 7 months after the last dose. Male patients with a female partner of childbearing potential must accept to take highly effective contraceptive measures during the treatment with the investigational medicinal product and for 4 months after the last dose.