To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Registration Number
- NCT04894591
- Lead Sponsor
- Jazz Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 272
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) up to 6 months after first infusion
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (41)
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
Pikeville Medical Center - Leonard Lawson Cancer Center
🇺🇸Pikeville, Kentucky, United States
West Jefferson Cancer Center
🇺🇸Marrero, Louisiana, United States
MMCORC - HealthPartners Institute
🇺🇸Saint Louis Park, Minnesota, United States
Singing River Health System
🇺🇸Pascagoula, Mississippi, United States
Central Care Cancer Center
🇺🇸Bolivar, Missouri, United States
Benefis Medical Group
🇺🇸Great Falls, Montana, United States
Regional Cancer Care Associates LLC (RCCA)
🇺🇸Hackensack, New Jersey, United States
Montefiore Medical Center (MMC) - Montefiore Medical Park (MMP)
🇺🇸Bronx, New York, United States
Center for Clinical Research-Rochester General Hospital
🇺🇸Rochester, New York, United States
University of North Carolina NASH Cancer Center
🇺🇸Rocky Mount, North Carolina, United States
Trinity Cancercare Center
🇺🇸Minot, North Dakota, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
Tri-County Hematology & Oncology Associates, Inc
🇺🇸Massillon, Ohio, United States
Lankenau Institute for Medical Research
🇺🇸Wynnewood, Pennsylvania, United States
Charleston Hematology Oncology Associates, PA
🇺🇸Charleston, South Carolina, United States
Carolina Blood & Cancer Care Associates
🇺🇸Rock Hill, South Carolina, United States
Lexington Oncology Associates
🇺🇸West Columbia, South Carolina, United States
Monument Health Cancer Care Institute
🇺🇸Rapid City, South Dakota, United States
Baptist Cancer Center
🇺🇸Memphis, Tennessee, United States
Baylor Scott & White Medical Center - Temple
🇺🇸Temple, Texas, United States
Tranquil Clinical Research
🇺🇸Webster, Texas, United States
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay-Lac-Saint-Jean
🇨🇦Chicoutimi, Quebec, Canada
ThedaCare Regional Cancer Center
🇺🇸Appleton, Wisconsin, United States
Southlake Regional Health Centre (York County Hospital)
🇨🇦Newmarket, Ontario, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Centre integre de Sante Et De Services Sociaux du Bas-Saint-Laurent Hopital regional de Rimousk
🇨🇦Rimouski, Quebec, Canada
Cape Breton Cancer Centre
🇨🇦Sydney, Nova Scotia, Canada
Centre integre de sante et de services sociaux de Chaudiere-Appalaches
🇨🇦Levis, Quebec, Canada
Universite Laval - Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) (Hopital Laval)
🇨🇦Sainte-Foy, Quebec, Canada
CIUSSS de L'Estrie - CHUS - Hopital Fleurimont
🇨🇦Sherbrooke, Quebec, Canada