Viewing Study NCT05498064



Ignite Creation Date: 2024-05-06 @ 5:58 PM
Last Modification Date: 2024-10-26 @ 2:39 PM
Study NCT ID: NCT05498064
Status: RECRUITING
Last Update Posted: 2022-08-11
First Post: 2022-05-17

Brief Title: A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
Sponsor: Peking Union Medical College Hospital
Organization: Peking Union Medical College Hospital

Study Overview

Official Title: A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer NSCLC
Status: RECRUITING
Status Verified Date: 2022-08
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 primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer and the mechanisms of population pharmacokinetics and resistance to Ensartinib
Detailed Description: Participants will receive Ensartinib at 225 mg orally once a day QD Treatments will continue until disease progression meeting one of treatment discontinuation criteria eg patient decision adverse event pregnancy At the time of disease progression participants will enter a survival follow-up until death withdrawal of consent or study closure whichever occurs earlier Collection of venous blood sample from participants included 3 times before treatment 8 weeks of treatment and disease progression Blood specimens of 8 ml were collected each time for ctDNA NGS testing and evaluation of Ensartinib population pharmacokinetics with blood sampling after 8 weeks

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