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Background: Concurrent chemotherapy and thoracic radiotherapy (CRT) followed by prophylactic cranial irradiation (PCI) is the standard strategy in limited stage small cell lung cancer (LS-SCLC). Methods: STIMULI is a 1:1 randomized phase II international trial aiming to demonstrate superiority of consolidation immunotherapy treatment (C) vs observation (O) after standard CRT and PCI, in patients (pts) with LS-SCLC. C consisted of four cycles of nivolumab (1 mg/kg, Q3W) plus ipilimumab (3 mg/kg, Q3W), followed by nivolumab monotherapy (240 mg, Q2W) for up to 12 months (m). The trial was designed to test two co-primary endpoints, progression-free survival (PFS) by RECIST 1.1 criteria, and overall survival (OS), at 1-sided alpha of 1% and 4%, respectively. Trial enrollment closed prematurely due to slow accrual, after half the initial sample size. The statistical analyses plan was updated to address PFS as primary endpoint to be tested at the full 5% 1-sided significance level. 81 PFS events were needed to achieve a power of 80% for testing an HR of 0.57. Secondary endpoints include OS, time to treatment failure (TTF), and safety.

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