Extensive-stage Small-cell Lung Cancer
Conditions
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 line of treatment with platinum-based chemotherapy. Patients enrolled in the study will be encouraged to complete patient reported outcome (PRO) questionnaires.
Interventions
DRUGZepzelca
Zepzelca is administered by intravenous infusion over 60 minutes every 21 days. Date, dose prescribed and received will be collected at each Zepzelca infusion.
Sponsors
Jazz Pharmaceuticals
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) | up to 6 months after first infusion |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | up to 6 months after first infusion |
| Progression-Free Survival (PFS) | up to 6 months after first infusion |
| Duration of Response (DoR) | up to 6 months after first infusion |
| Disease Control Rate (DCR) | up to 6 months after first infusion |
| Distribution of Treatment Patterns in Participants Measured by Number of Days in a Cycle, Dose Intensity, Number of Dose Reductions and Dose Delays, Number of Cycles Summarized by Number of Previous Lines of Therapy | up to 6 months after first infusion |
| Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | up to 6 months after first infusion |
| Time to Response to Zepzelca | up to 6 months after first infusion |
| Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires | up to 6 months after first infusion |
| Overall Survival (OS) in Other Subgroups of Interest | up to 6 months after first infusion |
| Progression-Free Survival (PFS) in Other Subgroups of Interest | up to 6 months after first infusion |
| Duration of Response (DoR) in Other Subgroups of Interest | up to 6 months after first infusion |
| Disease Control Rate (DCR) in Other Subgroups of Interest | up to 6 months after first infusion |
| Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with SAEs and AESI in Subgroups of Interest | up to 6 months after first infusion |
Countries
Canada, United States
Outcome results
None listed