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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)

NCT05153239 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 705

Last updated 2026-05-13

No results posted yet for this study

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 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.

Conditions

  • Relapsed Small Cell Lung Cancer

Interventions

DRUG

Irinotecan

Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk

DRUG

Lurbinectedin

Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk

DRUG

Irinotecan

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

DRUG

Topotecan

Topotecan 2.3 mg/m² oral or 1.5 mg/m² intravenously Days 1-5 q3wk

DRUG

Lurbinectedin

Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2026-04-10
Completion
2026-04-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Denmark
  • France
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Poland
  • Romania
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153239 on ClinicalTrials.gov