WCLC 2025 - Posters & ePosters-P3.18.12 ARIAN, Adjuvant Treatment With Sacituzumab and ZimberelimAb in Resected Patients: A Phase III Study

P3.18.12 ARIAN, Adjuvant Treatment With Sacituzumab and ZimberelimAb in Resected Patients: A Phase III Study - Trial in Progress

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The ARIAN study is a phase III, multicenter, open-label, randomized clinical trial evaluating the efficacy and safety of adjuvant treatments in patients with resected non-small cell lung cancer (NSCLC) who did not achieve pathological complete response (pCR) after neoadjuvant platinum-based chemotherapy and immunotherapy. Surgery remains the standard curative treatment for early and locally advanced NSCLC, but absence of pCR post-neoadjuvant therapy is linked to poorer outcomes. The trial investigates therapeutic synergy between immune checkpoint inhibitors (ICI) and the antibody-drug conjugate (ADC) Sacituzumab Govitecan targeting TROP-2.<br /><br />Key eligibility criteria include histologically confirmed stage IB to IIIB (T3N2) NSCLC, complete surgical resection (R0), no pCR, ECOG performance status 0–1, and no prior radiation or immune checkpoint inhibitor therapy. Patients with certain mutations (EGFR, ALK, STK11, KEAP1), autoimmune diseases, infections, or other comorbidities are excluded.<br /><br />A total of 129 patients are randomized into three arms based on PD-L1 status:<br />- Arm 1: Observation and chemotherapy as per investigator discretion (no immunotherapy).<br />- Arm 2: 13 cycles of Zimberelimab (anti-PD-1 antibody).<br />- Arm 3: Combination of 8 cycles Sacituzumab Govitecan plus Zimberelimab followed by 5 Zimberelimab monotherapy cycles.<br /><br />Primary endpoint is disease-free survival (DFS), with secondary endpoints including overall survival at 12, 24, and 36 months and safety evaluation. Exploratory endpoints involve assessing circulating tumor DNA (ctDNA) dynamics, resistance mechanisms, and immune response correlations.<br /><br />The study aims to demonstrate improved 2-year DFS probabilities of 48% (Arm 1), 65% (Arm 2), and 77% (Arm 3), with hazard ratios of 0.59 and 0.36 for Arms 2 and 3 respectively, using 80% power and 5% significance. The trial is approved by health authorities with 30 sites participating in Spain, funded by Gilead Sciences. Results will be analyzed using Cox models and survival analyses.

Asset Subtitle

Mariano Provencio

Meta Tag

Speaker Mariano Provencio

Topic Clinical Trials in Progress

Keywords

ARIAN study

non-small cell lung cancer

NSCLC

adjuvant treatment

neoadjuvant chemotherapy

immune checkpoint inhibitors

Sacituzumab Govitecan

Zimberelimab

disease-free survival

clinical trial