Extensive-stage Small-cell Lung CancerPhase 2NCT07459634
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
A Phase 2 study testing Lurbinectedin and Durvalumab in people with Extensive-stage Small-cell Lung Cancer, run by Jazz Pharmaceuticals at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy. 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?
- Lurbinectedin and Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Nov 2026to 30 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system).
- Participant has received 4 cycles of definitive platinum-based chemotherapy with at least 3 cycles of durvalumab
- Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.
- Adequate hematologic and end-organ function for at least 7 days prior to dosing.
- Has a body weight > 30 kg.
- Adequate contraceptive precautions.
Who cannot join
- Clinically confirmed leptomeningeal carcinomatosis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Significant cardiovascular disease within 3 months prior to enrollment
- History of another primary malignancy
- Presence or history of Central Nervous System (CNS) metastases
- History of allogeneic organ transplantation.
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- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan.
- Any concurrent chemotherapy, study intervention, biologic, or hormonal therapy for cancer treatment.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.
- Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the last dose of study intervention.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
- Recruiting
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
- Recruiting
Baptist Health
Lexington, Kentucky, 40503
- Recruiting
Valkyrie Clinical Trials, Inc.
Los Angeles, California, 90067
- Recruiting
Carolina Blood and Cancer Care
Rock Hill, South Carolina, 29732
About this study
Official title: A Phase 2, Multicenter, Open-Label, Single-Arm Study of Lurbinectedin in Combination With Durvalumab as First-line Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer Following Induction Treatment With Platinum Based Chemotherapy and Durvalumab
The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy.
Read the detailed description
The study will evaluate the safety and efficacy of lurbinectedin in combination with durvalumab as maintenance therapy in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen. In order to be considered for eligibility screening for the maintenance phase, participants need to have an ongoing CR, PR, or stable disease (SD) per RECIST v1.1 criteria after completion of 4 cycles of platinum plus etoposide containing regimen with at least 3 cycles of durvalumab during induction treatment.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Lurbinectedin, Durvalumab
- Keywords
- Zepzelca, Lurbinectedin, Durvalumab, Imfinzi
- 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.
LurbinectedinDrug
Also called Zepzelca
Administered by intravenous (IV) infusion
DurvalumabDrug
Also called Imfinzi
Administered by intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab and lurbinectedin treatment arm | Experimental | Durvalumab taken in combination with lurbinectedin in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen. Receives: Drug: Lurbinectedin; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator assessed PFS rate
Progression Free Survival (PFS) rate is the proportion of participants who have not experienced disease progression (as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) or death from any cause
Measured: 6 months
Secondary outcomes (5)
Investigator assessed PFS
PFS is defined as the time from the start of maintenance treatment until the first documentation of disease progression (as determined by the investigator according to RECIST v1.1) or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Investigator-assessed confirmed ORR
Confirmed Objective Response Rate (ORR) is the proportion of participants with Complete Response (CR) or Partial Response (PR) on 2 consecutive occasions ≥ 4 weeks apart, after the start of maintenance treatment, as determined by the investigator according to RECIST v1.1.
Measured: Up to 2 years
Number of participants requiring dose modification
Measured: Up to 2 years
Number of participants requiring discontinuations of any component of the combination therapy
Measured: Up to 2 years
Plasma Concentrations of lurbinectedin
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jazz Pharmaceuticals Ireland Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459634
- Sponsor's protocol ID
- JZP712-203
- Other IDs
- 2025-524566-13-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 5 Mar 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-Label, Single-Arm Study of Lurbinectedin in Combination With Durvalumab as First-line Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer Following Induction Treatment With Platinum Based Chemotherapy and Durvalumab
- ClinicalTrials.gov ID
- NCT07459634
- Acronym / sponsor ID
- JZP712-203
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Keywords
- Zepzelca, Lurbinectedin, Durvalumab, Imfinzi
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Jazz Pharmaceuticals Ireland Limited
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 10 Mar 2026 (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.
The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy.
Detailed description
The study will evaluate the safety and efficacy of lurbinectedin in combination with durvalumab as maintenance therapy in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen. In order to be considered for eligibility screening for the maintenance phase, participants need to have an ongoing CR, PR, or stable disease (SD) per RECIST v1.1 criteria after completion of 4 cycles of platinum plus etoposide containing regimen with at least 3 cycles of durvalumab during induction treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab and lurbinectedin treatment arm | Experimental | Drug: Lurbinectedin, Drug: DurvalumabDurvalumab taken in combination with lurbinectedin in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system).
- Participant has received 4 cycles of definitive platinum-based chemotherapy with at least 3 cycles of durvalumab
- Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.
- Adequate hematologic and end-organ function for at least 7 days prior to dosing.
Key exclusion criteria (10 listed)
- Clinically confirmed leptomeningeal carcinomatosis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Significant cardiovascular disease within 3 months prior to enrollment
- History of another primary malignancy
- Presence or history of Central Nervous System (CNS) metastases
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 |
|---|---|---|
| LurbinectedinAlso: ZepzelcaAdministered by intravenous (IV) infusion | Drug | Durvalumab and lurbinectedin treatment arm |
| DurvalumabAlso: ImfinziAdministered by intravenous (IV) infusion | Drug | Durvalumab and lurbinectedin treatment arm |
Primary outcome
Investigator assessed PFS rate
Time frame: 6 months
Progression Free Survival (PFS) rate is the proportion of participants who have not experienced disease progression (as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) or death from any cause
5 secondary outcomes
Investigator assessed PFS
Time frame: Up to 2 years
Investigator-assessed confirmed ORR
Time frame: Up to 2 years
Number of participants requiring dose modification
Time frame: Up to 2 years
Number of participants requiring discontinuations of any component of the combination therapy
Time frame: Up to 2 years
Plasma Concentrations of lurbinectedin
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lurbinectedin and Durvalumab in people with Extensive-stage Small-cell Lung Cancer, run by Jazz Pharmaceuticals at 5 sites in United States.
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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Disclosure & Transparency (215-832-3750, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator assessed PFS rate (time frame: 6 months). 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 17 Sep 2026.