Novocure Gets FDA Approval For Reducing Sample Size For Late-Stage Pivotal LUNAR Lung Cancer Study

The FDA has approved Novocure Ltd's NVCR Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for its LUNAR Phase 3 trial to 276 patients with 12 months follow-up.
The trial is testing the effectiveness of Tumor Treating Fields in combination with immune checkpoint inhibitors or docetaxel for patients with stage 4 non-small cell lung cancer (NSCLC) who progressed during or after platinum-based therapy.
The independent data monitoring committee (DMC) recommended reducing the sample size, which it believes will provide sufficient overall power for both primary and secondary endpoints.
Novocure remains blinded to all data.
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die.
Price Action: NVCR shares closed at $175 on Monday.

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