Novocure has announced that the final patient has been enrolled in the phase 3 pivotal LUNAR trial evaluating the efficacy of Tumor Treating Fields (TTFields) together with immune checkpoint inhibitors or docetaxel for treatment of patients with advanced stage 4, non-small cell lung cancer (NSCLC) following progression while on or after platinum-based therapy. Non-small cell lung cancer impacts nearly 200,000 patients every year in the U.S., and lung cancer is the leading cause of cancer-related death globally.
“LUNAR marks Novocure’s second phase 3 pivotal study to complete enrollment this quarter and is our first of several late-stage clinical trials expected to deliver final data over the next two years,” said William Doyle, Novocure’s Executive Chairman. “LUNAR will provide the first randomized dataset to evaluate increased survival when Tumor Treating Fields is used together with immunotherapy, versus immunotherapy alone. I am proud of our employees and am grateful to our principal investigators and patients for their courage and dedication to advancing clinical studies.”
LUNAR is a phase 3 pivotal trial testing the effectiveness of TTFields in combination with immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone for patients with stage 4 NSCLC who progressed during or after platinum-based therapy. It is estimated that approximately 46,000 patients receive second-line treatment for stage 4 NSCLC each year in the U.S. The primary endpoint is superior overall survival of patients treated with TTFields plus immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone. TTFields therapy is intended principally for use in combination with other standard-of-care treatments, and LUNAR was designed to generate data that contemplates multiple outcomes. Patients will be followed for 12 months with final data expected year-end 2022.