NCT07459634RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
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
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 5 Mar 2026
- Start date
- 30 Nov 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Jazz Pharmaceuticals
- Diseases
- Lung cancer
- NCT number
- NCT07459634
- EU CT number
- 2025-524566-13-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 30 Nov 2026 to the primary completion date, 31 Jan 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Significant cardiovascular disease within 3 months prior to enrollment
- 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.
Other illness
- History of another primary malignancy
- Presence or history of Central Nervous System (CNS) metastases
- History of allogeneic organ transplantation.
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan.
Other
- Clinically confirmed leptomeningeal carcinomatosis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the last dose of study intervention.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Cancer Specialists of North Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Baptist Health Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Valkyrie Clinical Trials, Inc Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Carolina Blood and Cancer Care Coordinator of this site? Confirm its status | Rock Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.