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

H

Hunan Province Tumor Hospital

Status

Enrolling

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Crizotinib

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Exclusion criteria

  • Patients received antitumor treatment before
  • Patients with contraindication of chemotherapy
  • Pregnant or breast feeding women

Trial design

40 participants in 1 patient group

Cohorts 1
Description:
ROS1 fusion positive NSCLC patients who received crizotinib
Treatment:
Drug: Crizotinib

Trial contacts and locations

1

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Central trial contact

Yongchang Zhang, MD; Nong Yang, MD

Data sourced from clinicaltrials.gov

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