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

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Crizotinib

• Registration Number: NCT03646994
• Lead Sponsor: Hunan Province Tumor Hospital

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-25
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohorts 1	Crizotinib	ROS1 fusion positive NSCLC patients who received crizotinib

Primary Outcome Measures

Name	Time	Method
PFS	may 2018- may 2019 (1 year)	progression survival time

Secondary Outcome Measures

Name	Time	Method
ORR	may 2018- may 2019 (1 year)	objective response rate
OS	may 2018- may 2019 (1 year)	over survival time

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China