Non-small cell lung cancer with EGFR mutation positive by ctDNA based NGS analysis
Conditions
Interventions
investigational material(s)
Generic name etc : AZD9291
INN of investigational material : Osimertinib Mesilate
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Inves
Sponsors
Department of Thoracic Oncology, National Cancer Center Hospital East
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Outcome results
None listed