Viewing Study NCT06092086



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Last Modification Date: 2024-10-26 @ 3:11 PM
Study NCT ID: NCT06092086
Status: RECRUITING
Last Update Posted: 2023-10-23
First Post: 2023-07-21

Brief Title: Lorlatinib as the First-line Treatment in China Advanced ALK NSCLC
Sponsor: Guangdong Association of Clinical Trials
Organization: Guangdong Association of Clinical Trials

Study Overview

Official Title: A Patient-Centric Open-Label Multicenter Phase II Study of Lorlatinib Monotherapy in The First-Line Treatment of Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer
Status: RECRUITING
Status Verified Date: 2023-10
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 phase II study is aim to investigate the efficacy resistance mechanism safety profile of first-line lorlatinib in China advanced ALK non-small cell lung cancer NSCLC Participants will receive continuous daily PO dosing of lorlatinib 100mg QD
Detailed Description: This is a patient-centric two cohorts open-label multi-center phase II study in China designed to prospectively enroll 126 advanced ALKNSCLC patients including 84 subjects fulfilled CROWN criteria as CROWN criteria CC cohort and another 42 subjects beyond CROWN criteria as compassionate use CU cohort Subjects will receive continuous daily PO dosing of lorlatinib 100mg QD from the date of first dosing until disease progression unacceptable toxicity or withdrawal for any reason or death whichever occurs first The primary endpoints are progression-free survival PFS of CC cohort per investigator and resistance mechanism of first-line lorlatinib Secondary endpoints are 123-year PFS cumulative rate of central nervous system CNS progression intracranial-time to progression IC-TTP objective response rate ORR and intracranial ORR IC-ORR overall survival OS safety and PRO Exploratory endpoints include evaluation of candidate biomarkers of sensitivity or resistance to lorlatinib dynamic ctDNA change during treatment and effective treatment after lorlatinib resistance

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