LAGOON: This phase III study is comparing how safe and effective an alkylating drug (lurbinectedin) is alone, or when combined with chemotherapy (irinotecan), compared to chemotherapy alone (irinotecan or topotecan) in people with relapsed small-cell lung cancerA 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)

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

Radiotherapy