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

Last updated: May 9, 2025
Sponsor: Jazz Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Small Cell Lung Cancer

Treatment

Zepzelca

Clinical Study ID

NCT04894591
JZP712-402
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient has initiated or will be receiving Zepzelca treatment in line with the localZepzelca prescribing information.

  2. Decision to initiate treatment with Zepzelca was made as per investigator's routinetreatment practice prior to enrollment in the study.

  3. Patient, or a legally acceptable representative, signed the informed consent beforeany 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. TheCTFI is defined as the length of time from last platinum dose to time of relapse ordisease progression.

  6. Eastern Cooperative Oncology Group performance status (ECOG) ≤1

Exclusion

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 currenttreatment schedule.

  3. Patient received treatment with any investigational agent within 30 days prior tofirst Zepzelca infusion or plans to use another investigational agent whilereceiving Zepzelca.

  4. Known CNS involvement prior to Zepzelca treatment.

  5. Patients who were treated with Zepzelca in later lines rather than in second-linetreatment

Study Design

Total Participants: 272
Treatment Group(s): 1
Primary Treatment: Zepzelca
Phase:
Study Start date:
June 28, 2021
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Horizon Health Network, The Moncton Hospital

    Moncton, New Brunswick E1C 6Z8
    Canada

    Site Not Available

  • Cape Breton Cancer Centre

    Sydney, Nova Scotia B1P 1P3
    Canada

    Site Not Available

  • Southlake Regional Health Centre (York County Hospital)

    Newmarket, Ontario L3Y 2P9
    Canada

    Site Not Available

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • CIUSSS du Saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec G7H 7M4
    Canada

    Active - Recruiting

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

    Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

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

    Levis, Quebec G6V 3Z1
    Canada

    Site Not Available

  • Centre integre de sante et de services sociaux de Chaudiere-Appalaches Levis, Quebec G6V 3Z1 Canada Recruiting

    Lévis, Quebec G6V 3Z1
    Canada

    Site Not Available

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

    Rimouski, Quebec G5L 5T1
    Canada

    Site Not Available

  • Integrated Health and Social Services Center of the Lower St. Lawrence (CISSS BSL)

    Rimouski, Quebec G5L 5T1
    Canada

    Active - Recruiting

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

    Sainte-Foy, Quebec G1V 4G5
    Canada

    Site Not Available

  • CIUSSS de L'Estrie - CHUS - Hopital Fleurimont

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • CIUSSS de l'Estrie - CHUS

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

  • Cape Breton Cancer Centre

    Nova Scotia, B1P 1P3
    Canada

    Site Not Available

  • Quebec Heart and Lung Institute (IUCPQ-UL)

    Québec, G1V 4G5
    Canada

    Site Not Available

  • Clearview Cancer Institute

    Huntsville, Alabama 35805
    United States

    Site Not Available

  • Oncology Specialties PC

    Huntsville, Alabama 35805
    United States

    Active - Recruiting

  • Pacific Cancer Medical Center, Inc

    Anaheim, California 92801
    United States

    Site Not Available

  • Eastern Connecticut Hematology And Oncology

    Norwich, Connecticut 06360
    United States

    Active - Recruiting

  • Eastern Connecticut Hematology and Oncology

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • ASCLEPES Research Centers

    Brooksville, Florida 34613
    United States

    Site Not Available

  • Woodlands Medical Specialists - Woodlands Center For Specialized Medicine

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Rural Reach Research dba 3R

    Boise, Idaho 83709
    United States

    Site Not Available

  • Mid-Illinois Hematology & Oncology Associates

    Normal, Illinois 61761
    United States

    Site Not Available

  • Mid-Illinois Hematology & Oncology Associates, Ltd.

    Normal, Illinois 61761
    United States

    Active - Recruiting

  • Goshen Center for Cancer Care

    Goshen, Indiana 46526
    United States

    Active - Recruiting

  • Goshen Health Center for Cancer Care

    Goshen, Indiana 46526
    United States

    Site Not Available

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa 51101
    United States

    Active - Recruiting

  • Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • Central Care Cancer Center

    Garden City, Kansas 67846
    United States

    Site Not Available

  • Stormont Vail Cancer Center - Stormont Vail Healthcare - Cotton-O´Neil Cancer Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

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

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Cancer Center of Kansas

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Pikeville Medical Center - Leonard Lawson Cancer Center

    Pikeville, Kentucky 41501
    United States

    Site Not Available

  • Pikeville Medical Center

    Pineville, Kentucky 41501
    United States

    Site Not Available

  • West Jefferson Cancer Center

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • West Jefferson Medical Center Cancer Center

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Michigan Center of Medical Research

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • MMCORC - HealthPartners Institute

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • MMCORC- HealthPartners Institute

    Saint Louis Park, Minnesota 55426
    United States

    Active - Recruiting

  • Singing River Health System

    Pascagoula, Mississippi 39581
    United States

    Site Not Available

  • Central Care Cancer Center

    Bolivar, Missouri 65613
    United States

    Site Not Available

  • Benefis Medical Group

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Benefis Sletten Cancer Institute

    Great Falls, Montana 59404
    United States

    Active - Recruiting

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Regional Cancer Care Associates LLC

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Regional Cancer Care Associates LLC (RCCA)

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Regional Cancre Care Associates, LLC (RCCA)

    Little Silver, New Jersey 07739
    United States

    Site Not Available

  • Regional Care Cancer Associates LLC

    Little Silver, New Jersey 07739
    United States

    Completed

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

    Bronx, New York 10461
    United States

    Site Not Available

  • Center for Clinical Research-Rochester General Hospital

    Rochester, New York 14625
    United States

    Site Not Available

  • Rochester General Hospital Lipson Cancer Institute

    Rochester, New York 14621
    United States

    Active - Recruiting

  • University of North Carolina NASH Cancer Center

    Rocky Mount, North Carolina 27804
    United States

    Site Not Available

  • University of North Carolina NASH Cancer Center - Danny Talbott Cancer Center

    Rocky Mount, North Carolina 27804
    United States

    Active - Recruiting

  • Marion L. Shepard Cancer Center

    Washington, North Carolina 27889
    United States

    Site Not Available

  • Trinity Cancercare Center

    Minot, North Dakota 58701
    United States

    Site Not Available

  • Trinity Health - Trinity Cancercare Center

    Minot, North Dakota 58701
    United States

    Active - Recruiting

  • Gabrail Cancer Center Research

    Canton, Ohio 44718
    United States

    Site Not Available

  • Tri-County Hematology & Oncology Associates, Inc

    Massillon, Ohio 44646
    United States

    Site Not Available

  • Tri-County Hematology and Oncology Associate, Inc.

    Massillon, Ohio 44646
    United States

    Active - Recruiting

  • 27889

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania 19096
    United States

    Site Not Available

  • Charleston Hematology Oncology Associates, PA

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Charleston Oncology

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Carolina Blood & Cancer Care Associates

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Carolina Blood and Cancer Care Associates, PA

    Rock Hill, South Carolina 29732
    United States

    Active - Recruiting

  • Lexington Oncology Associates

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Monument Health Cancer Care Institute

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Baptist Cancer Center

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Research Institute & Clinical Alliance

    Houston, Texas 77089
    United States

    Site Not Available

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas 76508
    United States

    Site Not Available

  • Renovatio Clinical

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

  • Renovatio Clinical - The Woodlands Research Center

    The Woodlands, Texas 77380
    United States

    Site Not Available

  • Tranquil Clinical Research

    Webster, Texas 77598
    United States

    Site Not Available

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin 54911
    United States

    Site Not Available

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