CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 296 enrolled
Drug / intervention
Lorlatinib +1 moredrug
Likely dose
Lorlatinib (specific dose not stated in provided text); Crizotinib (specific dose not stated in provided text)AI-extracted
Key inclusion· 6
  • ✓Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC
  • ✓At least 1 extracranial measurable target lesion not previously irradiated
  • ✓Availability of an archival FFPE tissue specimen
  • ✓No prior systemic NSCLC treatment
Key exclusion· 8
  • ✕Spinal cord compression unless good pain control attained
  • ✕Major surgery within 4 weeks prior to randomization
  • ✕Radiation therapy within 2 weeks prior to randomization; whole brain irradiation within 4 weeks prior to randomization
  • ✕Active bacterial, fungal, or viral infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03052608
NCT03052608Phase 3Active
CompareCT.gov

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

Pfizer·interventional·Posted Feb 14, 2017·Updated Nov 25, 2025

In Brief

A Phase 3 clinical trial evaluating Lorlatinib and Crizotinib for Carcinoma, Non-Small-Cell Lung. Active but no longer recruiting, targeting 296 participants across 166 sites in 23 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesArgentina, Australia, Belgium, Canada, China, Czechia, France, Germany, Hong Kong, India, Italy, Japan, Mexico, Netherlands, Poland, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
2017201820192020202120222023202420252026202720282029
First PostedFeb 14, 2017
Enrollment StartApr 27, 2017
Primary CompletionMar 20, 2020
Study CompletionDec 31, 2028
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.4 years ago

Interventions

Lorlatinibdrug

ALK-positive NSCL treatment

Crizotinibdrug

ALK-positive NSCL treatment