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 (SCLC) Patients (LAGOON Trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513559-34-00

Acronym

PM1183-C-008-21

Enrollment

517

Registered

2024-07-05

Start date

2022-07-19

Completion date

Unknown

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer (SCLC)

Brief summary

Overall survival (OS)

Detailed description

Progression-free survival (PFS) by Independent Review Committee (IRC)/Investigator's Assessment (IA), Overall response rate (ORR) by IRC/IA, OS rate at 12 and 24 months and PFS rate at 6 and 12 months by IRC/IA, Duration of response (DoR) by IRC/IA, Treatment safety profile, Patient-reported outcomes (PRO), Subgroup analyses: Subgroup analyses of efficacy and safety, Plasma pharmacokinetics (PK) of lurbinectedin, irinotecan and its metabolite SN-38, PK/PD correlation, Pharmacogenomics (PGx)

Interventions

DRUGTOPOTECAN

DRUGlurbinectedin

DRUGIRINOTECAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	—

Secondary

Measure	Time frame
Progression-free survival (PFS) by Independent Review Committee (IRC)/Investigator's Assessment (IA), Overall response rate (ORR) by IRC/IA, OS rate at 12 and 24 months and PFS rate at 6 and 12 months by IRC/IA, Duration of response (DoR) by IRC/IA, Treatment safety profile, Patient-reported outcomes (PRO), Subgroup analyses: Subgroup analyses of efficacy and safety, Plasma pharmacokinetics (PK) of lurbinectedin, irinotecan and its metabolite SN-38, PK/PD correlation, Pharmacogenomics (PGx)	—

Measure

Time frame

—

Countries

Austria, Belgium, Bulgaria, Denmark, France, Germany, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026