Phase II Study of Osimertinib in Patients with Advanced Non-Small-Cell Lung Carcinoma harboring EGFR mutation detected by Liquid Biopsy
E-Liquid
National Cancer Center Hospital East
6-5-1, Kashiwanoha Kashiwa-shi Chiba, 277-8577 Japan
+81-4-7133-1111
hudagawa@east.ncc.go.jp
IQVIA Services Japan K.K.
3-4-30, Miyahara Yodogawa-ku Osaka, 532-0003, Japan
+81-3-6859-9500
E-Liquid_ManagementOffice@iqvia.com
completed
Nov. 29, 2019
91
Interventional
The study is aimed at treating advanced or recurrent non-small cell lung cancer with EGFR gene mutation positive by liquid NGS analysis without previous chemotherapy, a multicenter, open-label, single-arm study with oral osimertinib.
treatment purpose
2
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
20age old over
No limit
Both
Non-small cell lung cancer with EGFR mutation positive by ctDNA based NGS analysis
investigational material(s)
Generic name etc : AZD9291
INN of investigational material : Osimertinib Mesilate
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Osimertinib Mesilate 80 mg is administered orally once daily.
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -
efficacy
The objective response rate (ORR) assessed by the Independent Radiology Review (IRR). ORR will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
safety
efficacy
ORR (including uncommon mutation or limited to uncommon mutation), ORR by the attending physician, duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and the clinical efficacy of EGFR gene mutations in tumor tissue specimens or cytology specimens (tumor specimens), including the consistency of therapeutic effects.
Department of Thoracic Oncology, National Cancer Center Hospital East
AstraZeneca
Japan Agency for Medical Research and Development
Commission expenses of Practical Research for Innovative Cancer Control
Institutional Review Board of Hokkaido University Hospital
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido 060-8648, Japan
