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

JZP712-402

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

2021-06-28

2030-06-30

2030-06-30

Recruiting

300

Inclusion Criteria: 1. Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information. 2. Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study. 3. Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken. 4. Patients initiating Zepzelca treatment in second-line. 5. 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. 6. Eastern Cooperative Oncology Group performance status (ECOG) ≤1 Exclusion Criteria: 1. Patients who discontinued a prior Zepzelca treatment due to adverse events. 2. Patient who received more than 2 cycles of Zepzelca treatment in their current treatment schedule. 3. 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. 4. Known CNS involvement prior to Zepzelca treatment. 5. Patients who were treated with Zepzelca in later lines rather than in second-line treatment

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2024-04-10