Trial Identifiers
Use the hyperlinks, where available to access additional clinical trial information.
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)
Commercial Sponsor
PharmaMar
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.