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NCT03052608 · ClinicalTrials.gov registry record · Phase 3
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 296
- Enrollment target
- 20
- Study locations
NCT03052608: Active Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Pfizer.
NCT03052608 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 296 participants, roughly in line with the 322-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target. The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03052608, a Phase 3 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 296 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by the independent radiologist or death due to any cause, whichever occurred first. PFS (in months) was calculated as (date of event or censoring-randomization+1)/30.4375. Progressive disease is defined per RECIST version 1.1, as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a refe
Conditions Studied
Interventions
- DRUG Lorlatinib
- DRUG Crizotinib
Study Locations (20)
Florida
- Florida Cancer Specialists - Altamonte Springs
- Florida Cancer Specialists - Brandon
- Florida Cancer Specialists - Clearwater
- Florida Cancer Specialists - Gainesville
- Florida Cancer Specialists - Largo
- Florida Cancer Specialists - Lecanto
- Florida Cancer Specialists - Orange City
- Florida Cancer Specialists - Orlando
- Florida Cancer Specialists - Spring Hill
- Florida Cancer Specialists - St. Petersburg
- Florida Cancer Specialists - Tampa
- Florida Cancer Specialists - Tavares
- Florida Cancer Specialists - The Villages
- Florida Cancer Specialists - Winter Park
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
- Massachusetts General Hospital - Boston
- Ophthalmic Consultants of Boston Inc - Boston
- The William P. Beetham Eye Institute, Joslin Diabetes Center - Boston
New York
- University of Rochester Cancer Center Pharmacy - Rochester
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2017-04-27 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
What the registry record for NCT03052608 still lists
NCT03052608 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 322-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target.
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 2 interventions - of which Lorlatinib is the first listed.
NCT03052608 names 20 study sites across 3 states, led by Florida, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT03052608 about?
NCT03052608 is a clinical study titled "A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC". 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 popu...
What is the current status of trial NCT03052608?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2017-04-27. Estimated completion is 2028-12-31.
What conditions does trial NCT03052608 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT03052608?
The interventions under investigation include: Lorlatinib (DRUG), Crizotinib (DRUG).
Who is sponsoring clinical trial NCT03052608?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03052608 being conducted?
This trial has 20 study locations across Florida, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Carcinoma, Non-Small Cell Lung
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03052608's enrollment target sits among peer trials
296 43rd of 130 higher than 88 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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