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

Introduction: PRIMALung is an EORTC-sponsored study, endorsed in the UK by Cancer Research UK. 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 UK 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, including 8 UK participating sites aiming to recruit 76 patients. Methods: Key eligibility: Diagnosis of SCLC (Limited or Extensive- Stage, stage I-IV). Standard therapy completed prior to randomisation. Absence of progression, brain metastases or leptomeningeal disease after completing therapy. ≤ 16 weeks from day 1 of last cycle of chemotherapy to randomisation. ECOG performance status ≤ 2. 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. Results: Open to recruitment 27/10/2022. 3 countries open to date (Belgium, Switzerland, UK). Conclusion: 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. Further information: https://clinicaltrials.gov/ct2/show/NCT04790253 or contact: UK Chief Investigator Corinne Faivre-Finn (corinne. [email protected]); UK Project Manager Clare Dempsey ([email protected]); EORTC ([email protected]); Liz Hackett ([email protected]) Disclosure: No significant relationships. [Figure presented]