PStudy with investigational drug PF-06463922 and comparator crizotinib in patients with a specific type of advanced lung cancer
- Conditions
- Health Condition 1: null- patients with advanced ALK positive non small cell lung cancer
- Registration Number
- CTRI/2018/01/011325
- Lead Sponsor
- Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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;
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate that lorlatinib as a single <br/ ><br>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 Outcome Measures
Name Time Method All analyses will be performed using the FA set. The analysis of PFS will be repeated based on the Investigatorâ??s assessment.Timepoint: NA