Clinical summary
Summary
Eligible participants will be randomly allocated to one of three treatment arms. In Arm 1 (Experimental), participants will receive Lurbinectedin alone, which will be administered intravenously at a dose of 3.2 mg/m² on Day 1 of every 3-week cycle. In Arm 2 (Experimental), participants will receive Lurbinectedin plus Irinotecan. Lurbinectedin will be administered intravenously at a dose of 2.0 mg/m² on Day 1 of every 3 week cycle. Irinotecan will be administered intravenously at a dose of 75 mg/m² On Days 1 and 8 of every 2 week cycle. In Arm 3 (Active Comparator), participants will receive the Investigator's choice prior to randomisation of either Irinotecan or Topotecan. Irinotecan will be administered intravenously at a dose of 350 mg/m² on Day 1 of every 3 week cycle. Topotecan will be administered either orally at a dose of 2.3 mg/m² or intravenously at a dose of 1.5 mg/m² on Days 1-5 of every 3 week cycle.Treatment Type
RadiotherapyAge
18+
More information
Trial Identifiers
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Commercial Sponsor
PharmaMar
Scientific Title
A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination With Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial)