Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)

Conditions

• Relapsed Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Irinotecan — DRUG
  Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk
• Lurbinectedin — DRUG
  Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
• Irinotecan — DRUG
  For patients aged \<70 years: irinotecan 350 mg/m² intravenously Day 1 q3wk For patients aged ≥70 years: irinotecan 300 mg/m² intravenously Day 1 q3wk
• Topotecan — DRUG
  Topotecan 2.3 mg/m² oral or 1.5 mg/m² intravenously Days 1-5 q3wk
• Lurbinectedin — DRUG
  Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk

Study Details

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

Key Dates

Start date

Jul 22, 2022

Status verified

May 2026

Primary completion

Apr 10, 2026

Completion

Apr 10, 2026

Study Design

Enrollment

705 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lurbinectedin
  Patients will consecutively receive lurbinectedin on Day 1 q3wk (every three weeks = one treatment cycle)
• Experimental: Lurbinectedin plus Irinotecan
  Patients will consecutively receive the following q3wk (every three weeks = one treatment cycle): * Irinotecan (Day 1 and Day 8) * Lurbinectedin (Day 1)
• Active Comparator: Control arm
  Best Investigator's choice prior to randomization between: * Irinotecan on Day 1 q3wk * Topotecan on Days 1-5 q3wk

Primary Outcome Measure

Overall survival [ Time Frame: From the date of randomization to the date of death or last contact, up to 39 months ]

Locations (15)

Related coverage on Hipa.ai

• Lurbinectedin Phase 3 LAGOON Trial for Relapsed SCLC Completes Primary Study
  Lurbinectedin · Apr 30, 2026 · ClinicalTrials.gov
• Lurbinectedin Phase 3 Trial for Relapsed SCLC Completes Primary Study
  Lurbinectedin · Apr 10, 2026 · ClinicalTrials.gov

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