研究单位:[1]Takeda[2]Sichuan Cancer Hospital & Institute Chengdu,China,610041[3]St George Hospital Kogarah,New South Wales,Australia,2137[4]GenesisCare North Shore St Leonards,New South Wales,Australia,2065[5]Princess Alexandra Hospital Woolloongabba,Queensland,Australia,4102[6]Flinders Medical Centre Bedford Park,South Australia,Australia,5042[7]Royal Hobart Hospital Hobart,Tasmania,Australia,7000[8]Medizinische Universitat Graz Graz,Austria,8036[9]Cliniques Universitaires Saint-Luc Bruxelles,Brussels,Belgium,1200[10]Grand Hopital de Charleroi asbl Charleroi,Hainaut,Belgium,6000[11]AZ Sint-Lucas Aalst,Oost-Vlaanderen,Belgium,9300
研究目的:
The purpose of this study is to compare the effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group.
Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC),intolerable harmful effects or another discontinuation criteria.