Phase II Study of Osimertinib in Patients with Advanced Non-Small-Cell Lung Carcinoma harboring EGFR mutation detected by Liquid Biopsy

Department of Thoracic Oncology, National Cancer Center Hospital East0 个研究点目标入组 91 人开始时间: 2020年2月12日最近更新: 2023年10月17日

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•Main Inclusion Criteria
•-Histologically- or cytologically-confirmed diagnosis of NSCLC.
•-Stage III , IV or postoperative recurrence with unresectable and incapable radical radiation therapy.
•-Liquid NGS analysis using Guardant360 revealed that the EGFR gene mutation other than the exon 20 insertion mutation (common mutation [exon19 deletion, exon21 L858R point mutation], or uncommon mutation [exon18 G719X point mutation, exon20 S768I point mutation, exon21 L861Q point mutation]). Compound mutations without the exon 20 insertion mutation are also eligible. (Regardless of EGFR gene mutation in histology or cytology)
•-one or more non-irradiated measurable lesions according to RECIST v1.1
•-Males and females age >= 20 years on the date of informed consent for study participation
•-An ECOG PS score of 0-2
•-Has sufficient organ functions
•-The patient has signed a written consent form after receiving written information about the trial prior to enrollment

•Main exclusion Criteria
•-Participating in another trial and receiving treatment
•-History of EGFR inhibitor administration
•-History of administration of immune checkpoint inhibitors.
•-Patient treated chemotherapy for lung cancer (excluding preoperative and postoperative chemotherapy whose administration has been completed at least 6 months prior to enrollment) or chest radiotherapy.
•-Has not recovered to grade 1 from acute toxicity of prior treatment
•-Symptomatic central nervous system metastasis
•-CT-confirmed or a history of interstitial pulmonary fibrosis, pneumonitis or interstitial lung disease
•-Patients with poor control or clinically problematic heart disease, such as myocardial infarction, unstable angina, congestive heart failure, congenital long QT syndrome diagnosed at screening.
•-It has factors that increase the risk of QTc prolongation or arrhythmia.
•-Pregnancy or breastfeeding
•-Patients who have been taking drugsthat have a strong inducing effect on CYP3A4, chinese medicine, or herbal supplements for at least 21 days before.
•-Patients with a history of hypersensitivity to Osimertinib or Osimertinib vehicles

发起方

Department of Thoracic Oncology, National Cancer Center Hospital East