PStudy with investigational drug PF-06463922 and comparator crizotinib in patients with a specific type of advanced lung cancer
- Conditions
- patients with advanced ALK positive non small cell lung cancer
- Registration Number
- CTRI/2018/01/011325
- Lead Sponsor
- Pfizer Inc
- Brief Summary
This is a Phase 3, multinational, multicenter (at approximately 160 sites) , randomized, openlabel, parallel 2-arm study in which approximately 280 patients with previously untreated advanced ALK-positive NSCLC will be randomized 1:1 to receive lorlatinib monotherapy or crizotinib monotherapy
This study will randomize approximately 280 patients in a 1:1 ratio to receive:
- Arm A: Lorlatinib single agent;
- 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 affect nominal days of each cycle.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 280
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 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. PFS based on blinded independent central review (BICR) assessment (RECIST v.1.1). To demonstrate that lorlatinib as a single 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 Investigator’s assessment. NA
Trial Locations
- Locations (6)
Apollo Research and Innovations
🇮🇳Hyderabad, ANDHRA PRADESH, India
Artemis Hospital
🇮🇳Gurgaon, HARYANA, India
Manipal Hospitals
🇮🇳Bangalore, KARNATAKA, India
Sahyadri Clinical Research and Development Center
🇮🇳Pune, MAHARASHTRA, India
Sir Ganga Ram Hospital
🇮🇳Delhi, DELHI, India
Srinivasam Cancer Care Hosptials India Pvt.Ltd
🇮🇳Bangalore, KARNATAKA, India
Apollo Research and Innovations🇮🇳Hyderabad, ANDHRA PRADESH, IndiaDr MudduVamshi KrishnaPrincipal investigator8106667893drmvkrishnaonco@gmail.com