Real World Study on First Line Crizotinib in ROS1 Rearranged Advanced Non-squamous Non-small Cell Lung Cancer

Sponsor

Hunan Province Tumor Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03646994

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was designed to explore the efficacy and safety of Crizotinib as a first-line treatment for advanced NSCLC with ROS1 rearrangement positive mutation in the real world, explore the new drug resistance mechanism of ROS1 under Crizotinib treatment and the consistency of plasma and tissue detection driving genes, and finally evaluate the mutation spectrum of plasma dynamic detection driving genes. In predicting the risk of disease progression.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Crizotinib

Detailed Description

This is a research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University. Retrospective study of 40 patients with advanced non-squamous non-small cell lung cancer (NSCLC) using Crizotinib ROS1 rearrangement positive mutation was conducted to observe the efficacy and safety of Crizotinib regimen in the real world.Exploratory research contents are as follows: 1. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the initial diagnosis; 2. Consistency between NGS and plasma gene test (NGS) at the progression of clozotinib treatment; 3. Drug resistance mechanism of clozotinib in ROS1 rearrangement positive NSCLC; 4. Plasma drug resistance. Large panel dynamic driven gene mutation analysis was used to construct disease progression risk model.

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ROS1-rearranged Non-squamous Non-small Cell Lung Cancer

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cohorts 1 ROS1 fusion positive NSCLC patients who received crizotinib	Drug: Crizotinib Crizotinib Cap 250 mg po bid

Arm

Intervention/Treatment

Cohorts 1

ROS1 fusion positive NSCLC patients who received crizotinib

Drug: Crizotinib

Crizotinib Cap 250 mg po bid

Outcome Measures

Primary Outcome Measures

PFS [may 2018- may 2019 (1 year)]
progression survival time

Secondary Outcome Measures

ORR [may 2018- may 2019 (1 year)]
objective response rate
OS [may 2018- may 2019 (1 year)]
over survival time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
ROS1 Arranged Positive
ROS1 Arranged Detection Method is NGS
First Diagnosis and Treatment
Treatment Plan is Kazolinib 250mg po bid