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

  • End date
    Dec 1, 2023
  • participants needed
  • sponsor
    Hunan Province Tumor Hospital
Updated on 16 March 2022
lung carcinoma
squamous non-small cell lung cancer
proto-oncogene tyrosine-protein kinase ros
non-squamous non-small cell lung cancer
Accepts healthy volunteers


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.


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.

Condition Non-small Cell Lung Cancer
Treatment Crizotinib
Clinical Study IdentifierNCT03646994
SponsorHunan Province Tumor Hospital
Last Modified on16 March 2022


Yes No Not Sure

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
Clear my responses

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