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

NCT ID: NCT04894591

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-28

Study Completion Date

2025-05-27

Brief Summary

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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

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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.

Conditions

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Extensive-stage Small-cell Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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lurbinectedin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jazz Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clearview Cancer Institute

Huntsville, Alabama, United States

Site Status

Eastern Connecticut Hematology and Oncology

Norwich, Connecticut, United States

Site Status

ASCLEPES Research Centers

Brooksville, Florida, United States

Site Status

Woodlands Medical Specialists - Woodlands Center For Specialized Medicine

Pensacola, Florida, United States

Site Status

Mid-Illinois Hematology & Oncology Associates

Normal, Illinois, United States

Site Status

Goshen Health Center for Cancer Care

Goshen, Indiana, United States

Site Status

Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

Sioux City, Iowa, United States

Site Status

Stormont-Vail Cancer Center-Stormont-Vail Healthcare - Cotton-O'Neil Cancer Center

Topeka, Kansas, United States

Site Status

Cancer Center of Kansas

Wichita, Kansas, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

Pikeville Medical Center - Leonard Lawson Cancer Center

Pikeville, Kentucky, United States

Site Status

West Jefferson Cancer Center

Marrero, Louisiana, United States

Site Status

MMCORC - HealthPartners Institute

Saint Louis Park, Minnesota, United States

Site Status

Singing River Health System

Pascagoula, Mississippi, United States

Site Status

Central Care Cancer Center

Bolivar, Missouri, United States

Site Status

Benefis Medical Group

Great Falls, Montana, United States

Site Status

Regional Cancer Care Associates LLC (RCCA)

Hackensack, New Jersey, United States

Site Status

Center for Clinical Research-Rochester General Hospital

Rochester, New York, United States

Site Status

Montefiore Medical Center (MMC) - Montefiore Medical Park (MMP)

The Bronx, New York, United States

Site Status

University of North Carolina NASH Cancer Center

Rocky Mount, North Carolina, United States

Site Status

Trinity Cancercare Center

Minot, North Dakota, United States

Site Status

Gabrail Cancer Center Research

Canton, Ohio, United States

Site Status

Tri-County Hematology & Oncology Associates, Inc

Massillon, Ohio, United States

Site Status

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

Site Status

Charleston Hematology Oncology Associates, PA

Charleston, South Carolina, United States

Site Status

Carolina Blood & Cancer Care Associates

Rock Hill, South Carolina, United States

Site Status

Lexington Oncology Associates

West Columbia, South Carolina, United States

Site Status

Monument Health Cancer Care Institute

Rapid City, South Dakota, United States

Site Status

Baptist Cancer Center

Memphis, Tennessee, United States

Site Status

Baylor Scott & White Medical Center - Temple

Temple, Texas, United States

Site Status

Tranquil Clinical Research

Webster, Texas, United States

Site Status

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Site Status

Cape Breton Cancer Centre

Sydney, Nova Scotia, Canada

Site Status

Southlake Regional Health Centre (York County Hospital)

Newmarket, Ontario, Canada

Site Status

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, Canada

Site Status

Centre integre de sante et de services sociaux de Chaudiere-Appalaches

Lévis, Quebec, Canada

Site Status

Centre integre de Sante Et De Services Sociaux du Bas-Saint-Laurent Hopital regional de Rimousk

Rimouski, Quebec, Canada

Site Status

Universite Laval - Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) (Hopital Laval)

Sainte-Foy, Quebec, Canada

Site Status

CIUSSS de L'Estrie - CHUS - Hopital Fleurimont

Sherbrooke, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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JZP712-402

Identifier Type: -

Identifier Source: org_study_id

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