A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

Official Title

A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF LORLATINIB (PF-06463922) MONOTHERAPY VERSUS CRIZOTINIB MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER

Summary:

A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population

Trial Description

Primary Outcome:

• Progression-free survival (PFS) based on blinded independent central review (BICR) assessment

• Overall Survival (OS)
• PFS based on Investigator's assessment
• Objective Response (OR) based on BICR and on Investigator's assessments
• Intracranial Objective Response (IC-OR) based on BICR assessment
• Intracranial Time to Progression (IC-TTP) based on BIRC assessment
• Duration of Response (DR) based on BIRC assessment
• intracranial Duration of Response (IC-DR) based on BICR assessment
• Time to Tumour Response (TTR) based on BIRC assessment
• Intracranial Time to Tumour Response (IC-TTR) based on BICR assessment
• PFS2 based on investigator's assessment
• Adverse Event (AE) as graded by NCI CTCAE v 4.03)
• Laboratory abnormalities as graded by NCI CTCAE v 4.03)
• Vital signs (blood pressure, pulse rate) and body weight
• Electrocardiograms (ECG)
• Echocardiograms or multigated acquisition scan (MUGA)
• Ophthalmology
• PRO as assessed by EORTC QLQ-C30, EORTC QLQ LC13, and EQ-5D-5L
• Tumour tissue biomarkers
• Peripheral blood cfDNA (circulating free Deoxyribonucleic acid) biomarkers

View this trial on ClinicalTrials.gov