NVCR - Novocure gets FDA approval of IDE supplement for late-stage lung cancer study

Novocure (NVCR) announces that the U.S. FDA has approved the company’s Investigational Device Exemption ((IDE)) supplement, reducing the enrollment requirement for its LUNAR trial to 276 non-small cell lung cancer ((NSCLC)) patients with a 12 months follow-up.Shares up nearly 8% premarket.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.After review of the interim analysis report earlier this year, an independent data monitoring committee ((DMC)) concluded that the LUNAR trial should continue with no evidence of increased systemic toxicity, the company said.The company anticipates last patient enrollment in the trial in the fourth quarter of 2021 with final data available next year.

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Novocure gets FDA approval of IDE supplement for late-stage lung cancer study