LUNAR研究的主要终点是使用TTFields联合免疫检查点抑制剂或者联合多西他赛治疗的患者总生存期 (OS) 优于单独使用免疫检查点抑制剂或者多西他赛的患者。最终分析还将包括对免疫检查点抑制剂和多西他赛亚组的总生存分析。Zhitong Financial APP learned that on April 13, Zaiding Pharmaceutical (ZLAB.US,09688) and Novocure (NVCR.US) jointly announced the latest progress of a phase III critical clinical study of LUNAR in patients with stage IV non-small cell lung cancer who received advanced platinum-containing chemotherapy.
After a routine review of the study by the independent data monitoring committee (DMC), Novocure was told that the predetermined interim analysis of the LUNAR study would be accelerated based on the current enrollment time and the number of events observed. A mid-term analysis of the LUNAR study included data from 210 patients accumulated up to February 2021. After reviewing the interim analysis report, DMC said that there is no evidence that tumor electric field therapy increases systemic toxicity and that LUNAR research should continue.
DMC also noted that continued recruitment up to 534 patients may be unnecessary and unethical for patients randomly assigned to the control group and followed up for 18 months. DMC recommends that the sample size of the study be reduced to 276 and the follow-up time be reduced to 12 months, which would also provide sufficient statistical efficiency for both primary and secondary endpoints of the study. In addition, DMC made no other comments on the design of the LUNAR study. At present, all data is still kept secret from Novocure.
The main end point of the LUNAR study was that the overall survival (OS) of patients treated with TTFields combined with immunocheckpoint inhibitors or combined with docetaxel was better than those treated with immunocheckpoint inhibitors or docetaxel alone. The final analysis will also include an overall survival analysis of immune checkpoint inhibitors and docetaxel groups.
Novocure has notified the US Food and Drug Administration (FDA) (FDA), of DMC's recommendations and has indicated that it will integrate the adjustments proposed by DMC into the (IDE) supplementary materials for the device exemption study.
