Phase II Study of Entrectinib in Patients with Advanced Non-Small-Cell Lung Carcinoma harboring ROS1 Rearrangement detected by Liquid Biopsy
- Conditions
- on-small cell lung cancer with ROS1 fusion positive by ctDNA based NGS analysis
- Registration Number
- JPRN-jRCT2031210004
- Lead Sponsor
- osaki Kaname
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
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 ROS1 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 ROS1 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 current/ medical history such as; myocardial infarction, angina, bypass grafting of coronary or periperal arteries, heart failure and stroke including transient ischemic attack within the past 3 months prior to Day 1.
-Pregnancy or breastfeeding
-Patients with a history of hypersensitivity to Entrectinib or Entrectinib vehicles
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), intracranial ORR (iORR), intracranial DoR (iDoR), CNS PFS, concordance between gene expression and treatment response in blood and tissue, and AE profile.