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Trial record 1 of 1 for:    emerge 402
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To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC) (SCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04894591
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

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.

Condition or disease Intervention/treatment
Extensive-stage Small-cell Lung Cancer Drug: Zepzelca

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer


Intervention Details:
  • 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.
    Other Name: lurbinectedin


Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: up to 24 months after first infusion ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: up to 24 months after first infusion ]
  2. Progression-Free Survival (PFS) [ Time Frame: up to 24 months after first infusion ]
  3. Duration of Response (DoR) [ Time Frame: up to 24 months after first infusion ]
  4. Disease Control Rate (DCR) [ Time Frame: up to 24 months after first infusion ]
  5. 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 24 months after first infusion ]
  6. 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 24 months after first infusion ]
  7. Time to Response to Zepzelca [ Time Frame: up to 24 months after first infusion ]
  8. Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires [ Time Frame: up to 24 months after first infusion ]
  9. Overall Survival (OS) in Other Subgroups of Interest [ Time Frame: up to 24 months after first infusion ]
  10. Progression-Free Survival (PFS) in Other Subgroups of Interest [ Time Frame: up to 24 months after first infusion ]
  11. Duration of Response (DoR) in Other Subgroups of Interest [ Time Frame: up to 24 months after first infusion ]
  12. Disease Control Rate (DCR) in Other Subgroups of Interest [ Time Frame: up to 24 months after first infusion ]
  13. Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with SAEs and AESI in Subgroups of Interest [ Time Frame: up to 24 months after first infusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult participants with extensive SCLC treated with Zepzelca.
Criteria

Inclusion Criteria:

  • Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information.
  • Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.
  • Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken.

Exclusion Criteria:

  • Patients who discontinued a prior Zepzelca treatment due to adverse events.
  • Patient who received more than 2 cycles of Zepzelca treatment in their current treatment schedule.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894591


Contacts
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Contact: Clinical Trial Disclosure & Transparency 215-832-3750 ClinicalTrialDisclosure@JazzPharma.com

Locations
Show Show 39 study locations
Sponsors and Collaborators
Jazz Pharmaceuticals
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04894591    
Other Study ID Numbers: JZP712-402
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022

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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
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms