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A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system).
2. Participant has received 4 cycles of definitive platinum-based chemotherapy with at least 3 cycles of durvalumab
3. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
4. Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.
5. Adequate hematologic and end-organ function for at least 7 days prior to dosing.
6. Has a body weight \> 30 kg.
7. Adequate contraceptive precautions.

Exclusion Criteria:

1. Clinically confirmed leptomeningeal carcinomatosis.
2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
3. Significant cardiovascular disease within 3 months prior to enrollment
4. History of another primary malignancy
5. Presence or history of Central Nervous System (CNS) metastases
6. History of allogeneic organ transplantation.
7. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan.
8. Any concurrent chemotherapy, study intervention, biologic, or hormonal therapy for cancer treatment.
9. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.
10. Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the last dose of study intervention.

About the study

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.

What is being tested

Sponsor: Jazz Pharmaceuticals · Participants: 50 · Started: Nov 30, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07459634

Locations in the U.S.

CaliforniaValkyrie Clinical Trials, Inc., Los Angeles
FloridaCancer Specialists of North Florida, Jacksonville
GeorgiaEmory University, Atlanta
KentuckyBaptist Health, Lexington
South CarolinaCarolina Blood and Cancer Care, Rock Hill

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.