Clinical trial NCT04894591: To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Extensive-stage Small-cell Lung Cancer
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants with extensive SCLC treated with Zepzelca.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: up to 6 months after first infusion
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 6 months after first infusion
measure: Progression-Free Survival (PFS)
timeFrame: up to 6 months after first infusion
measure: Duration of Response (DoR)
timeFrame: up to 6 months after first infusion
measure: Disease Control Rate (DCR)
timeFrame: up to 6 months after first infusion
measure: 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
timeFrame: up to 6 months after first infusion
measure: Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
timeFrame: up to 6 months after first infusion
measure: Time to Response to Zepzelca
timeFrame: up to 6 months after first infusion
measure: Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires
timeFrame: up to 6 months after first infusion
measure: Overall Survival (OS) in Other Subgroups of Interest
timeFrame: up to 6 months after first infusion
measure: Progression-Free Survival (PFS) in Other Subgroups of Interest
timeFrame: up to 6 months after first infusion
measure: Duration of Response (DoR) in Other Subgroups of Interest
timeFrame: up to 6 months after first infusion
measure: Disease Control Rate (DCR) in Other Subgroups of Interest
timeFrame: up to 6 months after first infusion
measure: Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with SAEs and AESI in Subgroups of Interest
timeFrame: up to 6 months after first infusion
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology
state: Connecticut
city: Brooksville
country: United States
facility: ASCLEPES Research Centers
state: Florida
city: Pensacola
country: United States
facility: Woodlands Medical Specialists - Woodlands Center For Specialized Medicine
state: Florida
city: Normal
country: United States
facility: Mid-Illinois Hematology & Oncology Associates
state: Illinois
city: Goshen
country: United States
facility: Goshen Health Center for Cancer Care
state: Indiana
city: Sioux City
country: United States
facility: Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
state: Iowa
city: Topeka
country: United States
facility: Stormont-Vail Cancer Center-Stormont-Vail Healthcare - Cotton-O'Neil Cancer Center
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Pikeville
country: United States
facility: Pikeville Medical Center - Leonard Lawson Cancer Center
state: Kentucky
city: Marrero
country: United States
facility: West Jefferson Cancer Center
state: Louisiana
city: Saint Louis Park
country: United States
facility: MMCORC - HealthPartners Institute
state: Minnesota
city: Pascagoula
country: United States
facility: Singing River Health System
state: Mississippi
city: Bolivar
country: United States
facility: Central Care Cancer Center
state: Missouri
city: Great Falls
country: United States
facility: Benefis Medical Group
state: Montana
city: Hackensack
country: United States
facility: Regional Cancer Care Associates LLC (RCCA)
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center (MMC) - Montefiore Medical Park (MMP)
state: New York
city: Rochester
country: United States
facility: Center for Clinical Research-Rochester General Hospital
state: New York
city: Rocky Mount
country: United States
facility: University of North Carolina NASH Cancer Center
state: North Carolina
city: Minot
country: United States
facility: Trinity Cancercare Center
state: North Dakota
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Massillon
country: United States
facility: Tri-County Hematology & Oncology Associates, Inc
state: Ohio
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, PA
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Blood & Cancer Care Associates
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Oncology Associates
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Cancer Care Institute
state: South Dakota
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Sydney
country: Canada
facility: Cape Breton Cancer Centre
state: Nova Scotia
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre (York County Hospital)
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay-Lac-Saint-Jean
state: Quebec
city: Levis
country: Canada
facility: Centre integre de sante et de services sociaux de Chaudiere-Appalaches
state: Quebec
city: Rimouski
country: Canada
facility: Centre integre de Sante Et De Services Sociaux du Bas-Saint-Laurent Hopital regional de Rimousk
state: Quebec
city: Sainte-Foy
country: Canada
facility: Universite Laval - Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) (Hopital Laval)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de L'Estrie - CHUS - Hopital Fleurimont
state: Quebec
Study officials:
References: