NCT07459634

A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC

A Phase 2, Multicenter, Open-Label, Single-Arm Study of Lurbinectedin in Combination With Durvalumab as First-line Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer Following Induction Treatment With Platinum Based Chemotherapy and Durvalumab

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy.

Detailed description

The study will evaluate the safety and efficacy of lurbinectedin in combination with durvalumab as maintenance therapy in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen. In order to be considered for eligibility screening for the maintenance phase, participants need to have an ongoing CR, PR, or stable disease (SD) per RECIST v1.1 criteria after completion of 4 cycles of durvalumab and platinum plus etoposide containing regimen induction treatment.

Conditions

• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Lurbinectedin	Administered by intravenous (IV) infusion
DRUG	Durvalumab	Administered by intravenous (IV) infusion

Timeline

• Start date: 2026-04-25
• Primary completion: 2028-01-31
• Completion: 2028-04-30
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study