Status:
COMPLETED
To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Extensive-stage Small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information.
- Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.
- Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken.
- Patients initiating Zepzelca treatment in second-line.
- Patients who are sensitive to platinum-based chemotherapy with CTFI≥180 days. The CTFI is defined as the length of time from last platinum dose to time of relapse or disease progression.
- Eastern Cooperative Oncology Group performance status (ECOG) ≤1
Exclusion
- Patients who discontinued a prior Zepzelca treatment due to adverse events.
- Patient who received more than 2 cycles of Zepzelca treatment in their current treatment schedule.
- Patient received treatment with any investigational agent within 30 days prior to first Zepzelca infusion or plans to use another investigational agent while receiving Zepzelca.
- Known CNS involvement prior to Zepzelca treatment.
- Patients who were treated with Zepzelca in later lines rather than in second-line treatment
Key Trial Info
Start Date :
June 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 27 2025
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT04894591
Start Date
June 28 2021
End Date
May 27 2025
Last Update
June 29 2025
Active Locations (41)
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1
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
2
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, United States, 06360
3
ASCLEPES Research Centers
Brooksville, Florida, United States, 34613
4
Woodlands Medical Specialists - Woodlands Center For Specialized Medicine
Pensacola, Florida, United States, 32503