Prophylactic cerebral irradiation or active brain magnetic resonance imaging surveillance in small-cell lung cancer patients (EORTC-1901: PRIMALung).

person Antonin Levy Gustave Roussy, Villejuif, France info_outline Antonin Levy, Thierry Berghmans, Nicolaus Andratschke, Giulia Leonetti, Michael Koller, Corinne Faivre-Finn

Authors person Antonin Levy Gustave Roussy, Villejuif, France info_outline Antonin Levy, Thierry Berghmans, Nicolaus Andratschke, Giulia Leonetti, Michael Koller, Corinne Faivre-Finn Organizations Gustave Roussy, Villejuif, France, Jules Bordet Institute, Hôpitaux Universitaires de Bruxelles, Université Libre de Bruxelles, Brussels, Belgium, Department of Radiation Oncology, University Hospital Zurich, Zurich, Switzerland, EORTC, Brussels, Belgium, Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany, Christie Hospital, Withington Manchester, United Kingdom Abstract Disclosures Research Funding Other Government Agency Astra Zeneca, EORTC LCG, PHRC-K (France), Ligue contre le Cancer (France), CE (Belgium), Swiss Cancer League (Switzerland) Background: PRIMALung is an EORTC-sponsored study. Primary objective is to show that overall survival with brain MRI surveillance alone is non-inferior to brain MRI surveillance combined with PCI in patients with SCLC. PCI is currently SOC in most institutions, but can be associated with neurocognitive toxicity and impact quality of life. 600 patients will be recruited from 50 EORTC centres in 10 countries. This study is currently recruiting and will play an important role in clarifying whether MRI surveillance is a viable strategy in SCLC. Furthermore, it will answer important questions about the role of PCI in the era of immunotherapy, particularly in ES-SCLC. Methods: Key eligibility: ECOG performance status ≤ 2 patients with SCLC (Limited or Extensive-Stage, stage I-IV) who did not progress after (≤ 16 weeks from day 1 of last cycle of chemotherapy to randomisation) completed standard therapy. Absence of progression, brain metastases or leptomeningeal disease after completing therapy. Trial Interventions: Patients will be randomised 1:1 to receive brain MRI surveillance with or without PCI (25Gy in 10 fractions). Primary objective - to show that overall survival with brain MRI surveillance alone is non-inferior to brain MRI surveillance combined with PCI. Secondary objectives - cognitive failure-free survival, quality of life and acute/late toxicities according to CTCAE v5.0. The trial was open to recruitment on 27/10/2022. Three countries open to date (Belgium, Switzerland, UK). Further sites in France, Poland and Austria will be open to recruitment Q1 2023. The first patient has been randomized on the 4 th of January 2023. Further information: https://clinicaltrials.gov/ct2/show/NCT04790253 contact: 1901@EORTC.org. Clinical trial information: NCT04790253.

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