NCT06496048
Recruiting
Phase 3
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)
Luye Pharma Group Ltd.1 site in 1 country180 target enrollmentStarted: September 14, 2024Last updated:
ConditionsRelapsed Small Cell Lung Cancer
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Luye Pharma Group Ltd.
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Overall survival (OS)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
- •Patients who have received prophylactic cranial irradiation (PCI) and radiotherapy (prophylactic and/or therapeutic) at other sites within 2 weeks prior to randomization.
- •Patients with limited-stage disease who plan to receive local or regional treatment (including PCI, thoracic radiotherapy, or both) during the study (Note: patients with extensive-stage disease may receive radiotherapy during the study if they meet the requirements as described in Section 5.8.1).
- •Patients who, at the screening visit, are about to receive radiotherapy, such as for painful bone metastasis and/or risk of spinal cord compression. Patients who have a history of bone marrow and/or stem cell transplantation and allogeneic transplantation.
- •Having received a live vaccine or attenuated live vaccine within 30 days before the first dose of the investigation medicinal product (inactivated vaccines are allowed).
- •Concomitant diseases:
- •Having unstable angina pectoris, myocardial infarction, congestive heart failure (CHF) of New York Heart Association (NYHA) class II or above, or clinically significant heart valve diseases within one year prior to screening.
Arms & Interventions
Lurbinectedin monotherapy
Experimental
Intervention: Lurbinectedin (Drug)
Lurbinectedin + Irinotecan combined therapy
Experimental
Intervention: Irinotecan (Drug)
Lurbinectedin + Irinotecan combined therapy
Experimental
Intervention: Lurbinectedin (Drug)
Topotecan
Active Comparator
Intervention: Topotecan (Drug)
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: 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
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)
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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