Viewing Study NCT03647111



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Last Modification Date: 2024-10-26 @ 12:52 PM
Study NCT ID: NCT03647111
Status: RECRUITING
Last Update Posted: 2023-12-27
First Post: 2018-08-23

Brief Title: Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer
Sponsor: Hunan Province Tumor Hospital
Organization: Hunan Province Tumor Hospital

Study Overview

Official Title: A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ALK Rearranged Advanced Non Squamous Non-small Cell Lung Cancer
Status: RECRUITING
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study aims to explore the efficacy and safety of Crizotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world
Detailed Description: According to the study of P11014 and P1029 Crizotinib is a first-line therapy for advanced non squamous non small cell lung cancer with positive ALK rearrangementThis study aims to explore the efficacy and safety of clozotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world Among them ALK positive was based on NGS test results exploring the new drug resistance mechanism of ALK under clozotinib treatment mode and consistency between plasma and tissue detection driving genes and finally assessing the role of plasma dynamic detection driving gene mutation spectrum in predicting disease progression risk A retrospective study of 120 patients with advanced NSCLC using clozotinib ALK positive mutation was conducted to observe the efficacy and safety of clozotinib regimen in the real world

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None