Clinical trial · Observational
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
NCT04894591CI-TRIAL-00104131SCLCcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the effectiveness and safety of Zepzelca in adult participants with extensive stage small cell lung cancer (SCLC) in real-world clinical practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zepzelca | Drug | Lurbinectedin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- up to 6 months after first infusion
Secondary outcomes (13)
- measure
- Overall Survival (OS)
- timeFrame
- up to 6 months after first infusion
- measure
- Progression-Free Survival (PFS)
- timeFrame
- up to 6 months after first infusion
- measure
- Duration of Response (DoR)
- timeFrame
- up to 6 months after first infusion
- measure
- Disease Control Rate (DCR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.