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NCT04894591 Clinical Trial

To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)

Extensive-stage Small-cell Lung Cancer Clinical Trial

— SCLC  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04894591
Other study ID # JZP712-402
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 28, 2021
Est. completion date June 30, 2030

Study information
Verified date June 2024
Source Jazz Pharmaceuticals
Contact Clinical Trial Disclosure & Transparency
Phone 215-832-3750
Email ClinicalTrialDisclosure@JazzPharma.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 300
Est. completion date June 30, 2030
Est. primary completion date June 30, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Zepzelca
Zepzelca is administered by intravenous infusion over 60 minutes every 21 days. Date, dose prescribed and received will be collected at each Zepzelca infusion.

Locations
Country Name City State
Canada Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay-Lac-Saint-Jean Chicoutimi Quebec
Canada Centre integre de sante et de services sociaux de Chaudiere-Appalaches Levis Quebec
Canada Horizon Health Network, The Moncton Hospital Moncton New Brunswick
Canada Southlake Regional Health Centre (York County Hospital) Newmarket Ontario
Canada The Ottawa Hospital Cancer Centre Ottawa Ontario
Canada Centre integre de Sante Et De Services Sociaux du Bas-Saint-Laurent Hopital regional de Rimousk Rimouski 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 Cape Breton Cancer Centre Sydney Nova Scotia
Canada Princess Margaret Cancer Centre Toronto Ontario
United States Pacific Cancer Medical Center, Inc Anaheim California
United States ThedaCare Regional Cancer Center Appleton Wisconsin
United States Rural Reach Research dba 3R Boise Idaho
United States Central Care Cancer Center Bolivar Missouri
United States Montefiore Medical Center (MMC) - Montefiore Medical Park (MMP) Bronx New York
United States ASCLEPES Research Centers Brooksville Florida
United States Gabrail Cancer Center Research Canton Ohio
United States Charleston Hematology Oncology Associates, PA Charleston South Carolina
United States Michigan Center of Medical Research Farmington Hills Michigan
United States Central Care Cancer Center Garden City Kansas
United States Goshen Health Center for Cancer Care Goshen Indiana
United States Benefis Medical Group Great Falls Montana
United States Regional Cancer Care Associates LLC (RCCA) Hackensack New Jersey
United States Research Institute & Clinical Alliance Houston Texas
United States Clearview Cancer Institute Huntsville Alabama
United States Baptist Health Lexington Lexington Kentucky
United States Regional Cancre Care Associates, LLC (RCCA) Little Silver New Jersey
United States West Jefferson Cancer Center Marrero Louisiana
United States Tri-County Hematology & Oncology Associates, Inc Massillon Ohio
United States Baptist Cancer Center Memphis Tennessee
United States Trinity Cancercare Center Minot North Dakota
United States Mid-Illinois Hematology & Oncology Associates Normal Illinois
United States Eastern Connecticut Hematology and Oncology Norwich Connecticut
United States Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha Nebraska
United States Singing River Health System Pascagoula Mississippi
United States Woodlands Medical Specialists - Woodlands Center For Specialized Medicine Pensacola Florida
United States Pikeville Medical Center - Leonard Lawson Cancer Center Pikeville Kentucky
United States Monument Health Cancer Care Institute Rapid City South Dakota
United States Center for Clinical Research-Rochester General Hospital Rochester New York
United States Carolina Blood & Cancer Care Associates Rock Hill South Carolina
United States University of North Carolina NASH Cancer Center Rocky Mount North Carolina
United States MMCORC - HealthPartners Institute Saint Louis Park Minnesota
United States Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Sioux City Iowa
United States Baylor Scott & White Medical Center - Temple Temple Texas
United States Renovatio Clinical - The Woodlands Research Center The Woodlands Texas
United States Stormont-Vail Cancer Center-Stormont-Vail Healthcare - Cotton-O'Neil Cancer Center Topeka Kansas
United States Marion L. Shepard Cancer Center Washington North Carolina
United States Tranquil Clinical Research Webster Texas
United States Lexington Oncology Associates West Columbia South Carolina
United States Cancer Center of Kansas Wichita Kansas
United States Lankenau Institute for Medical Research Wynnewood Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Response Rate (ORR) up to 24 months after first infusion
Secondary Overall Survival (OS) up to 24 months after first infusion
Secondary Progression-Free Survival (PFS) up to 24 months after first infusion
Secondary Duration of Response (DoR) up to 24 months after first infusion
Secondary Disease Control Rate (DCR) up to 24 months after first infusion
Secondary 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 24 months after first infusion
Secondary 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 24 months after first infusion
Secondary Time to Response to Zepzelca up to 24 months after first infusion
Secondary Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires up to 24 months after first infusion
Secondary Overall Survival (OS) in Other Subgroups of Interest up to 24 months after first infusion
Secondary Progression-Free Survival (PFS) in Other Subgroups of Interest up to 24 months after first infusion
Secondary Duration of Response (DoR) in Other Subgroups of Interest up to 24 months after first infusion
Secondary Disease Control Rate (DCR) in Other Subgroups of Interest up to 24 months after first infusion
Secondary Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with SAEs and AESI in Subgroups of Interest up to 24 months after first infusion
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