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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Investigator assessed PFS rate [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Investigator assessed PFS [Срок оценки: Up to 2 years]
• Investigator-assessed confirmed ORR [Срок оценки: Up to 2 years]
• Number of participants requiring dose modification [Срок оценки: Up to 2 years]
• Number of participants requiring discontinuations of any component of the combination therapy [Срок оценки: Up to 2 years]
• Plasma Concentrations of lurbinectedin [Срок оценки: Up to 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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