Relapsed Small Cell Lung Cancer / Topotecan / Irinotecan · Phase 3 Trial

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)

ClinicalTrials.gov · September 8, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed Phase 3 randomized controlled trial comparing lurbinectedin monotherapy and lurbinectedin plus irinotecan against investigator's choice (topotecan or irinotecan) in relapsed small-cell lung cancer. No efficacy or safety results have been posted in this registry record, precluding any assessment of clinical benefit.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Relapsed Small Cell Lung Cancer; age from 18 Years. Intervention: Lurbinectedin; Lurbinectedin plus Irinotecan. Compared with: Control arm — Active Comparator. n = 705. 210 sites across 24 countries.

Key findings

Safety

No efficacy, safety, or outcome results are reported in this registry record; only study design and enrollment are documented.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a completed Phase 3 RCT registration with no posted results; the primary endpoint (overall survival) and outcomes are not reported in this registry record, making it impossible to assess efficacy or safety.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Overall survival (assessed at From the date of randomization to the date of death or last contact, up to 39 m…)

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationRelapsed Small Cell Lung Cancer; age from 18 Years

Sample size705

InterventionLurbinectedin; Lurbinectedin plus Irinotecan

ComparatorControl arm — Active Comparator

Setting210 sites across 24 countries

Reported figures

Quoted from the source exactly as published.

Sample size705

PhasePhase 3

Primary outcome measureOverall survival, from date of randomization to date of death or last contact, up to 39 months

Study typeMulticenter, open-label, randomized, controlled

Caveats

No efficacy, safety, or outcome results are reported in this registry record; only study design and enrollment are documented.
Open-label design is subject to detection and performance bias.
Results must be obtained from peer-reviewed publication or updated registry posting to inform clinical practice.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Multicenter, open-label, randomized, controlled Phase 3 design.

Directness

strong

Directly addresses clinical question in relapsed SCLC population.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

moderate

Open-label design introduces bias; randomization and control arm present.

Sample adequacy

strong

705 participants enrolled, adequate for Phase 3 primary outcome assessment.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05153239). This is a study registration, not published results. Lead sponsor: PharmaMar. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 705 participants (ACTUAL). Conditions: Relapsed Small Cell Lung Cancer. Interventions: DRUG: Irinotecan; DRUG: Lurbinectedin; DRUG: Irinotecan; DRUG: Topotecan; DRUG: Lurbinectedin. Primary outcome measures: Overall survival , From the date of randomization to the date of death or last contact, up to 39 months. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT05153239Relapsed Small Cell Lung CancerTopotecanIrinotecanLurbinectedinPharmaMar