Supplemental Application accepted for Toripalimab + Chemo as Perioperative Treatment for Resectable Stage II-III NSCLC
The supplemental application is principally based on NEOTORCH (NCT04158440), a randomized, double-blind, placebo-controlled phase 3 clinical study aiming to compare the efficacy and safety of toripalimab or placebo in combination with chemotherapy as perioperative treatment for resectable stage II/III NSCLC patients. Led by principal investigator Professor Shun LU of Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, the study enrolled a total of 501 patients with resectable stage II-III NSCLC. The primary endpoints are event-free survival (EFS) in patients with stage III and stage II-III disease as assessed by researchers, and major pathological response (MPR) rate in patients with stage III and stage II-III disease as assessed by the Blind Independent Pathology Review Committee (BIPR). The secondary endpoints include overall survival (OS), EFS as assessed by the Independent Review Committee (IRC), pathological complete remission rate (pCR rate), disease-free survival (DFS) and safety.
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