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

Recruiting now · Phase 2

Conditions studied: Extensive-stage Small-cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT07459634

Run by

Jazz Pharmaceuticals

People needed

50

Starts

2026-08-30

Expected to finish

2028-04-30

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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.

You may not qualify if…

• History of leptomeningeal carcinomatosis.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• 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.
• 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.
• Concurrent enrollment in another clinical study
• Prior enrollment or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
• Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the last dose of study intervention.

Where it is running

• Valkyrie Clinical Trials, Inc. — Los Angeles, California, United States (enrolling)
• Cancer Specialists of North Florida — Jacksonville, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Carolina Blood and Cancer Care — Rock Hill, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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