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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: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system).

• Participant has received 4 cycles of definitive platinum-based chemotherapy with durvalumab

• Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

• Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.

• Adequate hematologic and end-organ function for at least 7 days prior to dosing.

• Has a body weight \> 30 kg.

• Adequate contraceptive precautions.

Locations
United States
California
Valkyrie Clinical Trials, Inc.
RECRUITING
Los Angeles
Florida
Cancer Specialists of North Florida
RECRUITING
Jacksonville
Georgia
Emory University
RECRUITING
Atlanta
South Carolina
Carolina Blood and Cancer Care
RECRUITING
Rock Hill
Contact Information
Primary
Clinical Trial Disclosure & Transparency
ClinicalTrialDisclosure@JazzPharma.com
215-832-3750
Time Frame
Start Date: 2026-08-30
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 50
Treatments
Experimental: Durvalumab and lurbinectedin treatment arm
Durvalumab taken in combination with lurbinectedin in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen.
Sponsors
Collaborators: Jazz Pharmaceuticals Ireland Limited
Leads: Jazz Pharmaceuticals

This content was sourced from clinicaltrials.gov