To assess the effectiveness and safety of Zepzelca in adult participants with extensive stage small cell lung cancer (SCLC) in real-world clinical practice.
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.
Study Type
OBSERVATIONAL
Enrollment
272
Zepzelca is administered by intravenous infusion over 60 minutes every 21 days. Date, dose prescribed and received will be collected at each Zepzelca infusion.
Overall Response Rate (ORR)
Time frame: up to 6 months after first infusion
Overall Survival (OS)
Time frame: up to 6 months after first infusion
Progression-Free Survival (PFS)
Time frame: up to 6 months after first infusion
Duration of Response (DoR)
Time frame: up to 6 months after first infusion
Disease Control Rate (DCR)
Time frame: 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
Time frame: 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)
Time frame: up to 6 months after first infusion
Time to Response to Zepzelca
Time frame: up to 6 months after first infusion
Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires
Time frame: up to 6 months after first infusion
Overall Survival (OS) in Other Subgroups of Interest
Time frame: up to 6 months after first infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clearview Cancer Institute
Huntsville, Alabama, United States
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, United States
ASCLEPES Research Centers
Brooksville, Florida, United States
Woodlands Medical Specialists - Woodlands Center For Specialized Medicine
Pensacola, Florida, United States
Mid-Illinois Hematology & Oncology Associates
Normal, Illinois, United States
Goshen Health Center for Cancer Care
Goshen, Indiana, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
Sioux City, Iowa, United States
Stormont-Vail Cancer Center-Stormont-Vail Healthcare - Cotton-O'Neil Cancer Center
Topeka, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
...and 31 more locations
Progression-Free Survival (PFS) in Other Subgroups of Interest
Time frame: up to 6 months after first infusion
Duration of Response (DoR) in Other Subgroups of Interest
Time frame: up to 6 months after first infusion
Disease Control Rate (DCR) in Other Subgroups of Interest
Time frame: 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
Time frame: up to 6 months after first infusion