The FDA has approved nivolumab in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adults with resectable non-small cell lung cance r (NSCLC) with tumors 4 cm or larger and/or node-positive. Following surgery, nivolumab will be used as a single-agent adjuvant therapy. This approval is for patients without known EGFR mutations or ALK rearrangements.

Clinical Trials The efficacy of nivolumab was evaluated in the CHECKMATE-77T trial (NCT04025879), a randomized, double-blind, placebo-controlled study. It involved 461 patients with previously untreated, resectable non-small cell lung cancer ( NSCLC ) ranging from Stage IIA to select Stage IIIB. Participants were randomized 1:1 to receive either nivolumab or placebo, alongside platinum-based chemotherapy every three weeks for up to four cycles as neoadjuvant therapy, followed by single-agent nivolumab or placebo…