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NCT Number: NCT04894591

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cape Breton Cancer Centre, Sydney, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Patients initiating Zepzelca treatment in second-line.
  • 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.
  • Eastern Cooperative Oncology Group performance status (ECOG) ≤1

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.
  • Known CNS involvement prior to Zepzelca treatment.
  • Patients who were treated with Zepzelca in later lines rather than in second-line treatment

Treatment and study plan

Zepzelca

Drug

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 names: lurbinectedin

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: up to 6 months after first infusion

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: up to 6 months after first infusion

  2. Progression-Free Survival (PFS)

    Time frame: up to 6 months after first infusion

  3. Duration of Response (DoR)

    Time frame: up to 6 months after first infusion

  4. Disease Control Rate (DCR)

    Time frame: up to 6 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 6 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 6 months after first infusion

  7. Time to Response to Zepzelca

    Time frame: up to 6 months after first infusion

  8. Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires

    Time frame: up to 6 months after first infusion

  9. Overall Survival (OS) in Other Subgroups of Interest

    Time frame: up to 6 months after first infusion

  10. Progression-Free Survival (PFS) in Other Subgroups of Interest

    Time frame: up to 6 months after first infusion

  11. Duration of Response (DoR) in Other Subgroups of Interest

    Time frame: up to 6 months after first infusion

  12. Disease Control Rate (DCR) in Other Subgroups of Interest

    Time frame: up to 6 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 6 months after first infusion

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: SCLC

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 20, 2021
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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