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TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

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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.

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