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
Secondary Outcome:
  • 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
  • Time to Tumour Response (TTR) based on BIRC assessment
  • Clinical Benefit Response (CBR) based on BIRC 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

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society