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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03646994
Enrollment
40
Registered
2018-08-24
Start date
2018-08-01
Completion date
2025-12-01
Last updated
2023-12-27

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

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

DRUGCrizotinib

Crizotinib Cap 250 mg po bid

Sponsors

Hunan Province Tumor Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
PFSmay 2018- may 2019 (1 year)progression survival time

Secondary

MeasureTime frameDescription
ORRmay 2018- may 2019 (1 year)objective response rate
OSmay 2018- may 2019 (1 year)over survival time

Countries

China

Contacts

Primary ContactYongchang Zhang, MD
zhangyongchang@csu.edu.cn+8613873123436
Backup ContactNong Yang, MD
yangnong0217@163.com+8613873123436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026