NCT04894591

To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)

Jazz Emerge 402: Phase IV Observational Study to Collect Safety and Outcome Data in Real-World Setting in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Zepzelca

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 272 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the effectiveness and safety of Zepzelca in adult participants with extensive stage small cell lung cancer (SCLC) in real-world clinical practice.

Detailed description

A phase IV, prospective, single arm, multi-center, observational study to collect safety and outcome data of Zepzelca in adult participants with extensive stage SCLC previously exposed to at least one line of treatment with platinum-based chemotherapy. Patients enrolled in the study will be encouraged to complete patient reported outcome (PRO) questionnaires.

Conditions

• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Zepzelca	Zepzelca is administered by intravenous infusion over 60 minutes every 21 days. Date, dose prescribed and received will be collected at each Zepzelca infusion.

Timeline

• Start date: 2021-06-28
• Primary completion: 2025-06-04
• Completion: 2025-06-04
• First posted: 2021-05-20
• Last updated: 2026-02-27

Locations

41 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study