Phase II Study of Selpercatinib in Patients with Advanced Non-Small-Cell Lung Carcinoma harboring RET Rearrangement detected by Liquid Biopsy
- Conditions
- on-small cell lung cancer with RET fusion positive by Liquid NGS analysis
- Registration Number
- JPRN-jRCT2031210005
- Lead Sponsor
- osaki Kaname
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 21
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
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective response rate (ORR) assessed by the Independent Radiology Review (IRR).
- Secondary Outcome Measures
Name Time Method 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.