Non-small cell lung cancer with RET fusion positive by Liquid NGS analysis
Conditions
Interventions
Selpercatinib 160 mg administered orally twice daily
Sponsors
Nosaki Kaname
Eligibility
Sex/Gender
All
Inclusion criteria
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 revealed that the RET fusion gene. -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: -Participating in another trial and receiving treatment -History of RET inhibitor administration -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, diagnosed at screening, or myocardial infarction within the past 6 months prior to Day 1. -Pregnancy or breastfeeding -Patients with a history of hypersensitivity to Selpelcatiinib or Selpelcatiinib vehicles -Patients who have been taking drug sthat have a strong inhibiting/inducing effect on CYP3A4, for at least 5 days before the intinal dose of the study drug. -Patients who have been taking drugs that may cause QTc prolongation for at least 5 days before the intinal dose of the study drug. -Patients who have been taking PPI for at least 7 days before the intinal dose of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective response rate (ORR) assessed by the Independent Radiology Review (IRR). | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR by the investigator, duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), Overall survival (OS), and AE rate. | — |
Contacts
Public ContactOperations Clicnial
IQVIA Services Japan G.K.
Outcome results
None listed