Health Condition 1: null- patients with advanced ALK positive non small cell lung cancer
Conditions
Interventions
Intervention1: Lorlatinib (PF 06463922): This study will randomize approximately 280 patients in a 1:1 ratio to receive:
1. Arm A: Lorlatinib single agent
2. Arm B: Crizotinib single agent.
A cycle duration will be 4 weeks (28 days) and will always be considered 4 weeks
irrespective of any dose delays/dosing interruptions or missed doses which may affec
2. Arm B: Crizotinib single agent. A cycle duration will be 4 weeks (28 days) and will always be considered 4 weeks irrespective of any dose delays/dosing interruptions or missed doses which may affec
Sponsors
Pfizer Inc
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients with histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC where ALK status is determined by the FDA-approved (for use in US) and CE (Conformité Européene) marked (for use ex-US) Ventana ALK (D5F3) CDx Assay;
Exclusion criteria
Exclusion criteria: -Spinal cord compression unless the patient has good pain control attained through therapy -Major surgery within 4 weeks prior to randomization -Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation -Gastrointestinal abnormalities, including inability to take oral medication -Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations -Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (eg, in case of known HBsAg or HCV antibody (positivity), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that lorlatinib as a single agent (Arm A) is superior to crizotinib alone (Arm B) in prolonging Progression-Free Survival (PFS) in advanced ALK-positive NSCLC patients who are treatment naïve.Timepoint: PFS based on blinded independent central review (BICR) assessment (RECIST v.1.1). | — |
Secondary
| Measure | Time frame |
|---|---|
| All analyses will be performed using the FA set. The analysis of PFS will be repeated based on the Investigatorâ??s assessment.Timepoint: NA | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Mexico, Netherlands, Poland, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Seema Pai
Pfizer Limited
Outcome results
None listed