122TiP Phase III study of durvalumab with SBRT for unresected stage I/II, lymph-node negative NSCLC (PACIFIC-4/RTOG 3515)

Stereotactic body radiation therapy (SBRT) is a standard treatment for pts with unresectable (UR) stage I/II, lymph-node negative NSCLC, with excellent safety and high rates of primary tumor control. Despite predominant regional and distant failure that increases with tumor size, no adjuvant therapy is approved for these pts. Durvalumab (D) is a selective, high-affinity, human IgG1 monoclonal antibody that blocks PD-L1 binding to PD-1/CD80. In the placebo (pbo)-controlled phase (ph) 3 PACIFIC trial of pts with stage III UR-NSCLC without progression on/after concurrent chemoradiotherapy, D improved PFS and OS with manageable safety (Antonia et al, 2017; 2018), leading to its approval in stage III UR-NSCLC.