Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
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.
180 participants
Sep 14, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Lurbinectedin 3.2 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)
Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk
Lurbinectedin 2.0 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)
Topotecan 1.2 mg/m² intravenously Days 1-5 q3wk
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06496048