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Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC

StatusRecruiting
PhasePhase 3
Started2024-09-14
View on ClinicalTrials.gov ↗

Amendment history

2024-12-09
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-08-31→confirmed 2024-09-14
Study sites0→1
Study titlerevised
Lurbinectedin or in Combination Withwith Irinotecan Versus Topotecan in Patients Withwith Relapsed SCLC
2024-07-03
Original filing
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.
Trial Details
NCT Number NCT06496048
Lead Sponsor Luye Pharma Group Ltd.
Conditions Relapsed Small Cell Lung Cancer
Enrollment 180 participants
Start Date 2024-09-14
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-12