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

RecruitingPhase 2Ages 18 Years - anyAllJazz Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • Lurbinectedin
  • Durvalumab
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Where

5 sites
Valkyrie Clinical Trials, Inc.
Los Angeles, United States
Cancer Specialists of North Florida
Jacksonville, United States
Emory University
Atlanta, United States
Baptist Health
Lexington, United States
Carolina Blood and Cancer Care
Rock Hill, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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