Non-small Cell Lung Cancer
Conditions
Keywords
Non-small Cell Lung Cancer, Crizotinib, ROS1 Rearranged
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.
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.
Interventions
Crizotinib Cap 250 mg po bid
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | may 2018- may 2019 (1 year) | progression survival time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | may 2018- may 2019 (1 year) | objective response rate |
| OS | may 2018- may 2019 (1 year) | over survival time |
Countries
China