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2023/4/25更新:Sponsor由康方变成Summit Therapeutics;U.S. FDA-regulated Drug,从No变成YES;增加OS作为双终点;招募标准仍然是“Have previously received EGFR-TKI treatment and the treatment has failed”;
同年5/23更新:招募标准修改为:Have previously received 3rd generation EGFR-TKI treatment and have progressed on or following;
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国内部分,January 1, 2022就开始入组了。
2022年12月交流就说得很清楚了,中国入组的病人,80%接受过三代EGFR Tki,也是基于此,FDA同意把中国数据纳入global trial里面。