Viewing Study NCT03215693



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Last Modification Date: 2024-10-26 @ 12:27 PM
Study NCT ID: NCT03215693
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-08-16
First Post: 2017-07-11

Brief Title: X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Sponsor: Betta Pharmaceuticals Co Ltd
Organization: Betta Pharmaceuticals Co Ltd

Study Overview

Official Title: A Phase II Multicenter Single-arm Study to Evaluate Safety and Efficacy of X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-07
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: The main purpose of the study is to evaluate safety and efficacy of X-396Ensartinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinibWhile exploring the relationship between biomarkers and drug efficacy and safety
Detailed Description: This is a phase II multicenter single-arm study in which the safety and efficacy of X-396Ensartinib will be assessed in adult Chinese patients with ALK-positiverearrangement non-small cell lung cancer previously treated with crizotinib Approximately 144 patients with locally advanced or metastatic NSCLC which carry ALK -rearrangement will be enrolled in the study

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