Novocure, Inc. announced the US FDA has approved the company’s Investigational Device Exemption supplement, reducing the enrollment requirement for its LUNAR trial to 276 patients with 12 months follow-up. LUNAR is a phase 3 pivotal trial testing the effectiveness of Tumor Treating Fields in combination with immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone for patients with stage IV NSCLC who progressed during or after platinum-based therapy.
[Novocure, Inc. (Business Wire, Inc.)]