Novocure a global oncology company have announced the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) 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 4 NSCLC who progressed during or after platinum-based therapy.
The IDE supplement incorporates recommended changes from the interim analysis of the LUNAR trial conducted by an independent data monitoring committee (DMC). After review of the interim analysis report earlier this year, the DMC concluded that the LUNAR trial should continue with no evidence of increased systemic toxicity. The DMC also stated that it is likely unnecessary and possibly unethical for patients randomized to the control arm of the trial to continue accrual according to the original protocol. The DMC recommended a reduced sample size of approximately 276 patients with 12 months follow-up which it believes will provide sufficient overall power for both primary and secondary endpoints. The DMC recommended no other changes to the trial design. Novocure remains blinded to all data.
“We are very pleased with the FDA approval of the DMC’s recommended protocol adjustments and are grateful for the FDA’s prompt review,” said Asaf Danziger, Novocure’s CEO. “We now anticipate last patient enrollment in the LUNAR trial in the fourth quarter of 2021 with final data available in 2022 and look forward to sharing data from the LUNAR trial as quickly as possible.”