P2.07-02 Association between OS and Subsequent ICI in Control Arm Patients of First Line ICI-based RCTs of Advanced/Metastatic NSCLC: FDA Analysis

Immune checkpoint inhibitors (ICI), alone or in combination with chemotherapy (chemo) improved overall survival (OS) compared to chemo alone in patients with advanced/metastatic non-small cell lung cancer (mNSCLC) in multiple randomized controlled trials (RCTs) conducted in both first line (1L) and later-line treatment settings. However, many RCTs evaluating the efficacy of ICI-based regimens for the 1L treatment of mNSCLC do not permit crossover from chemo control arms to ICI-based arm(s) due to concerns that such crossover may negatively impact trial OS outcomes.