To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)
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
1 other identifier
observational
272
2 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Start
First participant enrolled
June 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2025
CompletedFebruary 27, 2026
February 1, 2026
3.9 years
April 30, 2021
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
up to 6 months after first infusion
Secondary Outcomes (13)
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
- +8 more secondary outcomes
Interventions
Zepzelca is administered by intravenous infusion over 60 minutes every 21 days. Date, dose prescribed and received will be collected at each Zepzelca infusion.
Eligibility Criteria
Adult participants with extensive SCLC treated with Zepzelca.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, 06360, United States
ASCLEPES Research Centers
Brooksville, Florida, 34613, United States
Woodlands Medical Specialists - Woodlands Center For Specialized Medicine
Pensacola, Florida, 32503, United States
Mid-Illinois Hematology & Oncology Associates
Normal, Illinois, 61761, United States
Goshen Health Center for Cancer Care
Goshen, Indiana, 46526, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
Sioux City, Iowa, 51101, United States
Stormont-Vail Cancer Center-Stormont-Vail Healthcare - Cotton-O'Neil Cancer Center
Topeka, Kansas, 66606, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Pikeville Medical Center - Leonard Lawson Cancer Center
Pikeville, Kentucky, 41501, United States
West Jefferson Cancer Center
Marrero, Louisiana, 70072, United States
MMCORC - HealthPartners Institute
Saint Louis Park, Minnesota, 55416, United States
Singing River Health System
Pascagoula, Mississippi, 39581, United States
Central Care Cancer Center
Bolivar, Missouri, 65613, United States
Benefis Medical Group
Great Falls, Montana, 59405, United States
Regional Cancer Care Associates LLC (RCCA)
Hackensack, New Jersey, 07601, United States
Center for Clinical Research-Rochester General Hospital
Rochester, New York, 14625, United States
Montefiore Medical Center (MMC) - Montefiore Medical Park (MMP)
The Bronx, New York, 10461, United States
University of North Carolina NASH Cancer Center
Rocky Mount, North Carolina, 27804, United States
Trinity Cancercare Center
Minot, North Dakota, 58701, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
Tri-County Hematology & Oncology Associates, Inc
Massillon, Ohio, 44646, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29414, United States
Carolina Blood & Cancer Care Associates
Rock Hill, South Carolina, 29732, United States
Lexington Oncology Associates
West Columbia, South Carolina, 29169, United States
Monument Health Cancer Care Institute
Rapid City, South Dakota, 57701, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508, United States
Tranquil Clinical Research
Webster, Texas, 77598, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Cape Breton Cancer Centre
Sydney, Nova Scotia, B1P 1P3, Canada
Southlake Regional Health Centre (York County Hospital)
Newmarket, Ontario, L3Y 2P9, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6, Canada
Centre integre de sante et de services sociaux de Chaudiere-Appalaches
Lévis, Quebec, G6V 3Z1, Canada
Centre integre de Sante Et De Services Sociaux du Bas-Saint-Laurent Hopital regional de Rimousk
Rimouski, Quebec, G5L 5T1, Canada
Universite Laval - Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) (Hopital Laval)
Sainte-Foy, Quebec, G1V 4G5, Canada
CIUSSS de L'Estrie - CHUS - Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2021
First Posted
May 20, 2021
Study Start
June 28, 2021
Primary Completion
June 4, 2025
Study Completion
June 4, 2025
Last Updated
February 27, 2026
Record last verified: 2026-02