Phase II Study of Entrectinib in Patients with Advanced Non-Small-Cell Lung Carcinoma harboring ROS1 Rearrangement detected by Liquid Biopsy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210004

Enrollment

Registered

2021-04-02

Start date

2020-12-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer with ROS1 fusion positive by ctDNA based NGS analysis

Interventions

Entrectinib 600mg administered orally once daily

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 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

Exclusion criteria

Exclusion criteria: -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

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), intracranial ORR (iORR), intracranial DoR (iDoR), CNS PFS, concordance between gene expression and treatment response in blood and tissue, and AE profile.	—

Contacts

Public ContactOperations Clicnial

IQVIA Services Japan G.K.

RET-Liquid_ManagementOffice@iqvia.com+81-3-6859-9500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026