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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03646994
• Other study ID #: CORE
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2023
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Crizotinib
Crizotinib Cap 250 mg po bid

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progression survival time	may 2018- may 2019 (1 year)
Secondary	ORR	objective response rate	may 2018- may 2019 (1 year)
Secondary	OS	over survival time	may 2018- may 2019 (1 year)