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

February 24, 2026 updated by: Jazz Pharmaceuticals

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

To assess the effectiveness and safety of Zepzelca in adult participants with extensive stage small cell lung cancer (SCLC) in real-world clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
272

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Cape Breton Cancer Centre
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre (York County Hospital)
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean
      • Lévis, Quebec, Canada, G6V 3Z1
        • Centre integre de sante et de services sociaux de Chaudiere-Appalaches
      • Rimouski, Quebec, Canada, G5L 5T1
        • Centre integre de Sante Et De Services Sociaux du Bas-Saint-Laurent Hopital regional de Rimousk
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • Universite Laval - Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) (Hopital Laval)
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Clearview Cancer Institute
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology and Oncology
    • Florida
      • Brooksville, Florida, United States, 34613
        • Asclepes Research Centers
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists - Woodlands Center For Specialized Medicine
    • Illinois
      • Normal, Illinois, United States, 61761
        • Mid-Illinois Hematology & Oncology Associates
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Goshen Health Center for Cancer Care
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Stormont-Vail Cancer Center-Stormont-Vail Healthcare - Cotton-O'Neil Cancer Center
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Pikeville, Kentucky, United States, 41501
        • Pikeville Medical Center - Leonard Lawson Cancer Center
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • West Jefferson Cancer Center
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • MMCORC - HealthPartners Institute
    • Mississippi
      • Pascagoula, Mississippi, United States, 39581
        • Singing River Health System
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center
    • Montana
      • Great Falls, Montana, United States, 59405
        • Benefis Medical Group
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Regional Cancer Care Associates LLC (RCCA)
    • New York
      • Rochester, New York, United States, 14625
        • Center for Clinical Research-Rochester General Hospital
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center (MMC) - Montefiore Medical Park (MMP)
    • North Carolina
      • Rocky Mount, North Carolina, United States, 27804
        • University of North Carolina NASH Cancer Center
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Trinity Cancercare Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center Research
      • Massillon, Ohio, United States, 44646
        • Tri-County Hematology & Oncology Associates, Inc
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Institute for Medical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology Associates, PA
      • Rock Hill, South Carolina, United States, 29732
        • Carolina Blood & Cancer Care Associates
      • West Columbia, South Carolina, United States, 29169
        • Lexington Oncology Associates
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Monument Health Cancer Care Institute
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Cancer Center
    • Texas
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Medical Center - Temple
      • Webster, Texas, United States, 77598
        • Tranquil Clinical Research
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • ThedaCare Regional Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult participants with extensive SCLC treated with Zepzelca.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Response Rate (ORR)
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion
Progression-Free Survival (PFS)
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion
Duration of Response (DoR)
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion
Disease Control Rate (DCR)
Time Frame: up to 6 months after first infusion
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
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion
Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion
Time to Response to Zepzelca
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion
Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion
Overall Survival (OS) in Other Subgroups of Interest
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion
Progression-Free Survival (PFS) in Other Subgroups of Interest
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion
Duration of Response (DoR) in Other Subgroups of Interest
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion
Disease Control Rate (DCR) in Other Subgroups of Interest
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion
Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with SAEs and AESI in Subgroups of Interest
Time Frame: up to 6 months after first infusion
up to 6 months after first infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jazz Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JZP712-402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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