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Bronchial Neoplasms

Lorlatinib

Michael Duruisseaux

Denis Moro-Sibilot

Crizotinib is a first-generation ALK tyrosine kinase inhibitor (ITK-ALK). It is the standard first-line treatment for patients with advanced NSCLC with ALK gene rearrangement. Alectinib, ceritinib and brigatinib are second-generation ITK-ALK. They have been shown to be effective in the first line of treatment in randomized trials. Alectinib has shown superiority to crizotinib as the first line of treatment in three randomized therapeutic trials, positioning this ITK-ALK as the treatment of choice in first-line treatment. Despite the effectiveness of these new treatments, all patients will virtually experience a relapse. There is no data on second-generation TKI-ALK resistance mechanisms when given as first-line treatment and the best therapeutic strategy for progression is undefined.

A phase II non-randomized, single group assignment, open-label, multicenter

Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer

A Phase II Non-randomized, Single Group Assignment, Open-label, Multicenter Study of Efficacy and Safety of Lorlatinib Monotherapy After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer

ORR is defined as the proportion of patients achieving an objective response (complete response (CR) or partial response (PR)) according to Response Evaluation Criteria in Solid Tumors (RECIST), v.1.1 (RECIST 1.1), as assessed by the investigators.

Response according to RECIST v.1.1 as assessed by an independent review committee (IRC)

PFS is defined as the time between the date of inclusion and the first date of documented disease progression according to RECIST 1.1 as assessed by the investigator and the IRC or death from any cause during the study, whichever occurs first.

DCR is defined as the percentage of participants with CR, PR, or stable disease (SD) for at least twelve weeks, according to RECIST 1.1.

DOR is defined as the time from the first occurrence of an objective response (CR or PR), based on RECIST 1.1 to first documented disease progression or death assessed by an IRC.

OS is defined as the time from the first lorlatinib dose and death from any cause during the study. OS will be assessed at 6 months, at 12 months and at 18 months.

TTR is defined as the time from the first lorlatinib dose and the first occurrence of an objective response (CR or PR) based on RECIST 1.1 and assessed by an IRC.

CNS ORR is defined as the proportion of patients achieving an objective response (complete response (CR) or partial response (PR)) of the baseline measurable and non-measurable CNS disease according to RECIST 1.1 and Revised Assessment in Neuro Oncology (RANO) criteria, as assessed by an IRC.

CNS PFS is defined as the proportion of patients achieving an objective response (complete response (CR) or partial response (PR)) of the baseline measurable and non-measurable CNS disease according to RECIST 1.1 and Revised Assessment in Neuro Oncology (RANO) criteria, as assessed by an IRC

CNS DOR is defined as the time from the first occurrence of an objective response (CR or PR) of the baseline measurable and non-measurable CNS disease for at least twelve weeks, according to RECIST 1.1. and Revised Assessment in Neuro Oncology (RANO) criteria, as assessed by an IRC.

CNS TTR is defined as the time from the first lorlatinib dose and the first occurrence of an objective response (CR or PR) of the baseline measurable and non-measurable CNS disease, according to RECIST 1.1. and Revised Assessment in Neuro Oncology (RANO) criteria, as assessed by an IRC.

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Spots Global Cancer Trial Database for orakle

Every month we try and update this database with for orakle cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for orakle cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.