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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment50 people
  • Recruiting US sites5
  • SponsorJazz Pharmaceuticals
  • RegistryNCT07459634

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC: a one-minute explainerNCT074596341 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join 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 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.

You cannot join if

  • 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.
  • 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

lurbinectedin. A synthetic tetrahydropyrrolo [4, 3, 2-de]quinolin-8(1H)-one alkaloid analogue with potential antineoplastic activity. Lurbinectedin covalently binds to residues lying in the minor groove of DNA, which may result in delayed progression through S phase, cell cycle arrest in the G2/M phase and cell death. NCI Drug Dictionary

durvalumab. A monoclonal antibody directed against B7H1 (B7 homolog 1; programmed cell death ligand 1) with potential immunostimulating activity. Upon intravenous administration, durvalumab binds to the cell surface antigen B7H1, thereby blocking B7H1 signaling. This may activate the immune system to exert a cytotoxic T-lymphocyte (CTL) response against B7H1-expressing tumor cells. B7H1, a member of the B7 protein superfamily and a negative regulator of cytokine synthesis, is overexpressed on certain tumor cell types. NCI Drug Dictionary

Treatments listed in the registry

  • Lurbinectedin (Drug): Administered by intravenous (IV) infusion
  • Durvalumab (Drug): Administered by intravenous (IV) infusion

The study

Treatment groups

Na · Single Group · masking: None

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.

Goals

What the study measures

Main goals

  • Investigator assessed PFS rate (6 months)

Other goals

  • Investigator assessed PFS
  • Investigator-assessed confirmed ORR
  • Number of participants requiring dose modification
  • Number of participants requiring discontinuations of any component of the combination therapy
  • Plasma Concentrations of lurbinectedin

Planned enrollment: 50 (estimated).

Where

Recruiting US sites

  • Valkyrie Clinical Trials, Inc., Los Angeles, California
  • Cancer Specialists of North Florida, Jacksonville, Florida
  • Emory University, Atlanta, Georgia
  • Baptist Health, Lexington, Kentucky
  • Carolina Blood and Cancer Care, Rock Hill, South Carolina

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 16, 2026. Public record; not medical advice.

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