Clinical Trial: NCT03052608
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Pfizer |
| Information Provided By: | Pfizer |
| Last Update Posted: | 2025-11-25 |
Study Overview
Brief 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
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
Conditions
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment
- Drug: Lorlatinib
- Drug: Crizotinib
Other Study ID Numbers
- B7461006
- 2023-509169-19-00
- 2023
Start Date (Actual)
2017-04-27
Primary Completion Date (Actual)
2020-03-20
Study Completion Date (Estimated)
2028-12-31
Enrollment (Actual)
296
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Pfizer |
| Information Provided By: | Pfizer |
| Last Update Posted: | 2025-11-25 |
Study Overview
Brief 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
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
Conditions
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment
- Drug: Lorlatinib
- Drug: Crizotinib
Other Study ID Numbers
- B7461006
- 2023-509169-19-00
- 2023
Start Date (Actual)
2017-04-27
Primary Completion Date (Actual)
2020-03-20
Study Completion Date (Estimated)
2028-12-31
Enrollment (Actual)
296
Study Type
Interventional
Phase
Phase 3