Immunotherapy has drastically altered the treatment of advanced-stage non-small cell lung cancer (NSCLC). For a study, researchers sought to determine if stereotactic body radiation therapy (SBRT) to a single tumor site could significantly improve the prognosis of patients with advanced-stage Programmed Death-Ligand 1 (PD-L1)-negative NSCLC when combined with systemic immunotherapy. Alliance A082002 was based on subgroup analysis from the randomized phase II PEMBRO-RT study., PEMBRO-RT compared pembrolizumab alone or with SBRT and demonstrated increased progression-free and overall survival (PFS and OS) in PD-L1(-) patients when adding SBRT (8 Gy x 3 fractions). A082002 will randomize patients without PD-L1 expression to SBRT (8 Gy x3) plus systemic therapy versus systemic therapy alone. The primary endpoint of the phase II component of the trial would be PFS, and 100 patients would be required. The primary endpoint of the phase III component of the trial would be OS, and an additional 284 patients would be required. This study determined whether adding SBRT to systemic treatment could improve PFS and OS in a larger, multi-institutional population. There were other systemic treatment options, including immunotherapy alone or chemo-immunotherapy. This phase II/III Alliance trial A082002 would examine whether the addition of SBRT to a single tumor site enhanced the antitumor activity of systemic immunotherapy or chemo-immunotherapy in patients with PD-L1(-) NSCLC at stage IV. It was now available through the National Clinical Trials Network (NCTN).

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