DARES: A Phase II Trial of Durvalumab and Ablative Radiation in Extensive-Stage Small Cell Lung Cancer.

Autor: Bestvina CM; Department of Medicine, Section of Hematology and Oncology, The University of Chicago Medicine, Chicago, IL., Hara JHL; Department of Radiation Oncology, The Queen's Medical Center, Honolulu, HI., Karrison T; Department of Public Health Sciences, The University of Chicago, Chicago, IL., Bowar B; Department of Pharmacy, University of Chicago Medical Center, Chicago, IL., Chin J; Department of Medicine, Section of Hematology and Oncology, The University of Chicago Medicine, Chicago, IL., Garassino MC; Department of Medicine, Section of Hematology and Oncology, The University of Chicago Medicine, Chicago, IL., Pitroda SP; Department of Radiation and Cellular Oncology, The University of Chicago Medicine, Chicago, IL., Thawani R; Department of Medicine, Section of Hematology and Oncology, The University of Chicago Medicine, Chicago, IL., Vokes EE; Department of Medicine, Section of Hematology and Oncology, The University of Chicago Medicine, Chicago, IL., Gan G; Department of Radiation Oncology, Department of Cancer Biology, University of Kansas Medical Center, Kansas City, KS., Zhang J; Department of Internal Medicine, Division of Medical Oncology; Department of Cancer Biology, University of Kansas Medical Center, Kansas City, KS., Baschnagel AM; Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, WI., Campbell TC; Department of Medicine, University of Wisconsin-Madison, Madison, WI., Chmura S; Department of Radiation and Cellular Oncology, The University of Chicago Medicine, Chicago, IL., Juloori A; Department of Radiation and Cellular Oncology, The University of Chicago Medicine, Chicago, IL. Electronic address: ajuloori@radonc.uchicago.edu.
Jazyk: angličtina
Zdroj: Clinical lung cancer [Clin Lung Cancer] 2024 Aug 13. Date of Electronic Publication: 2024 Aug 13.
DOI: 10.1016/j.cllc.2024.08.004
Abstrakt: Background: Immunotherapy in combination with chemotherapy is first-line treatment for patients with extensive-stage small-cell lung cancer (ES-SCLC). Growing evidence suggests that radiation, specifically stereotactic body radiation therapy (SBRT), may enhance the immunogenic response as well as cytoreduce tumor burden. The primary objective of the study is to determine the progression free survival for patients with newly diagnosed ES-SCLC treated with combination multisite SBRT and chemo-immunotherapy (carboplatin, etoposide, and durvalumab).
Methods: This is a multicenter, single arm, phase 2 study. Patients with treatment-naïve, ES-SCLC will be eligible for this study. Patients will receive durvalumab 1500mg IV q3w, carboplatin AUC 5 to 6 mg/mL q3w, and etoposide 80 to 100 mg/m2 on days 1 to 3 q3w for four cycles, followed by durvalumab 1500mg IV q4w until disease progression or unacceptable toxicity. Ablative radiation will be delivered 1 to 4 extracranial sites in 3 or 5 fractions, determined by location, during cycle 2. The primary endpoint is progression-free survival, measured from day 1 of chemoimmunotherapy. Secondary endpoints include grade ≥3 toxicity by CTCAE v5.0 within three months of RT, overall survival, response rate, time to second line systemic therapy, and time to new distant progression.
Conclusions: Now that immunotherapy is an established part of ES-SCLC management, it is important to further optimize its use and effect. This study will investigate the progression-free survival of combined SBRT and chemo-immunotherapy in patients with ES-SCLC. In addition, the data from this study may further inform the immunogenic role of SBRT with chemo-immunotherapy, as well as identify clinical, biological, or radiomic prognostic features.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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