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Recruiting NCT07459634

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

Phase II Interventional Extensive-stage Small-cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lurbinectedin, Durvalumab.
Who it may be relevant to
Registry conditions: Extensive-stage Small-cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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 durvalumab and platinum plus etoposide containing regimen induction treatment.

Interventions

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

Primary outcome measures

  • Investigator assessed PFS rate [Time frame: 6 months]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Valkyrie Clinical Trials, Inc. — Los Angeles
  • Cancer Specialists of North Florida — Jacksonville
  • Emory University — Atlanta
  • Carolina Blood and Cancer Care — Rock Hill

Identifiers

NCT: NCT07459634 · JZP712-203 · 2025-524566-13-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗