SPRING: A Worldwide Innovative Network (WIN) Consortium phase I study of triple therapy (avelumab, axitinib, and palbociclib) in advanced non small cell lung cancer (NSCLC …

9581Background: The Worldwide Innovative Network (WIN) Consortium has developed the Simplified Interventional Mapping System (SIMS) algorithm in order to predict treatment response by comparing tumor and normal tissue biopsies on both genomic and transcriptomic platforms. SPRING is the first trial to assess a SIMS-based tri-therapy regimen in advanced non-small cell lung cancer (NSCLC). Methods: Patients with advanced NSCLC (no EGFR or ALK alterations; no ROS1 alterations if tested; PD-L1 unrestricted; ≤2 prior therapy lines) were treated with avelumab, axitinib, and palbociclib (3+3 dose escalation design). Tumor and normal endobronchial mucosal biopsies were obtained on all patients for retrospective SIMS algorithm validation. Results: Fifteen patients were treated: 6 at dose level 1 (DL1); 6, dose level 2 (DL2); 3, dose level 3 (DL3). Three dose-limiting toxicities (DLTs) at least possibly drug …