Extensive-stage Small-cell Lung CancerSCLCNCT04894591
To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)
An observational study of Extensive-stage Small-cell Lung Cancer, run by Jazz Pharmaceuticals at 41 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Zepzelca
- Type of treatment
- Injection or infusion
- How many people
- 272 participants
- Where
- 41 sitesin 2 countries
- Study dates
- 28 Jun 2021to 4 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with extensive SCLC treated with Zepzelca.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
United States32 sites
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Central Care Cancer Center
Bolivar, Missouri, 65613
ASCLEPES Research Centers
Brooksville, Florida, 34613
Gabrail Cancer Center Research
Canton, Ohio, 44718
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29414
Goshen Health Center for Cancer Care
Goshen, Indiana, 46526
Benefis Medical Group
Great Falls, Montana, 59405
Regional Cancer Care Associates LLC (RCCA)
Hackensack, New Jersey, 07601
Clearview Cancer Institute
Huntsville, Alabama, 35805
Baptist Health Lexington
Lexington, Kentucky, 40503
West Jefferson Cancer Center
Marrero, Louisiana, 70072
Tri-County Hematology & Oncology Associates, Inc
Massillon, Ohio, 44646
Baptist Cancer Center
Memphis, Tennessee, 38120
Trinity Cancercare Center
Minot, North Dakota, 58701
Mid-Illinois Hematology & Oncology Associates
Normal, Illinois, 61761
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, 06360
Singing River Health System
Pascagoula, Mississippi, 39581
Woodlands Medical Specialists - Woodlands Center For Specialized Medicine
Pensacola, Florida, 32503
Pikeville Medical Center - Leonard Lawson Cancer Center
Pikeville, Kentucky, 41501
Monument Health Cancer Care Institute
Rapid City, South Dakota, 57701
Center for Clinical Research-Rochester General Hospital
Rochester, New York, 14625
Carolina Blood & Cancer Care Associates
Rock Hill, South Carolina, 29732
University of North Carolina NASH Cancer Center
Rocky Mount, North Carolina, 27804
MMCORC - HealthPartners Institute
Saint Louis Park, Minnesota, 55416
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
Sioux City, Iowa, 51101
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508
Montefiore Medical Center (MMC) - Montefiore Medical Park (MMP)
The Bronx, New York, 10461
Stormont-Vail Cancer Center-Stormont-Vail Healthcare - Cotton-O'Neil Cancer Center
Topeka, Kansas, 66606
Tranquil Clinical Research
Webster, Texas, 77598
Lexington Oncology Associates
West Columbia, South Carolina, 29169
Cancer Center of Kansas
Wichita, Kansas, 67214
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
Canada9 sites
Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6
Centre integre de sante et de services sociaux de Chaudiere-Appalaches
Lévis, Quebec, G6V 3Z1
Southlake Regional Health Centre (York County Hospital)
Newmarket, Ontario, L3Y 2P9
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Centre integre de Sante Et De Services Sociaux du Bas-Saint-Laurent Hopital regional de Rimousk
Rimouski, Quebec, G5L 5T1
Universite Laval - Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) (Hopital Laval)
Sainte-Foy, Quebec, G1V 4G5
CIUSSS de L'Estrie - CHUS - Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
Cape Breton Cancer Centre
Sydney, Nova Scotia, B1P 1P3
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official 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
To assess the effectiveness and safety of Zepzelca in adult participants with extensive stage small cell lung cancer (SCLC) in real-world clinical practice.
Read the 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.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Zepzelca
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZepzelcaDrug
Also called lurbinectedin
Zepzelca is administered by intravenous infusion over 60 minutes every 21 days. Date, dose prescribed and received will be collected at each Zepzelca infusion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Measured: up to 6 months after first infusion
Secondary outcomes (13)
Overall Survival (OS)
Measured: up to 6 months after first infusion
Progression-Free Survival (PFS)
Measured: up to 6 months after first infusion
Duration of Response (DoR)
Measured: up to 6 months after first infusion
Disease Control Rate (DCR)
Measured: 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
Measured: 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)
Measured: up to 6 months after first infusion
Time to Response to Zepzelca
Measured: up to 6 months after first infusion
Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires
Measured: up to 6 months after first infusion
Overall Survival (OS) in Other Subgroups of Interest
Measured: up to 6 months after first infusion
Progression-Free Survival (PFS) in Other Subgroups of Interest
Measured: up to 6 months after first infusion
Duration of Response (DoR) in Other Subgroups of Interest
Measured: up to 6 months after first infusion
Disease Control Rate (DCR) in Other Subgroups of Interest
Measured: 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
Measured: up to 6 months after first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start28 Jun 2021
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894591
- Sponsor's protocol ID
- JZP712-402
- Acronym
- SCLC
- Status last verified
- Feb 2026
- First submitted
- 30 Apr 2021
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04894591
- Acronym / sponsor ID
- SCLC / JZP712-402
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with extensive SCLC treated with Zepzelca.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZepzelcaAlso: lurbinectedinZepzelca is administered by intravenous infusion over 60 minutes every 21 days. Date, dose prescribed and received will be collected at each Zepzelca infusion. | Drug | – |
Primary outcome
Overall Response Rate (ORR)
Time frame: up to 6 months after first infusion
13 secondary outcomes
Overall Survival (OS)
Time frame: up to 6 months after first infusion
Progression-Free Survival (PFS)
Time frame: up to 6 months after first infusion
Duration of Response (DoR)
Time frame: up to 6 months after first infusion
Disease Control Rate (DCR)
Time frame: 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
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
Time to Response to Zepzelca
Time frame: 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
Overall Survival (OS) in Other Subgroups of Interest
Time frame: 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
Duration of Response (DoR) in Other Subgroups of Interest
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extensive-stage Small-cell Lung Cancer, run by Jazz Pharmaceuticals at 41 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: up to 6 months after first infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.