Who is eligible for clinical trial NCT03052608?

Participants must meet the protocol's inclusion criteria for Carcinoma, Non-Small-Cell Lung. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT03052608 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-11-19

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC (NCT03052608)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Pfizer

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (17 items).

Location: Florida Cancer Specialists — Altamonte Springs, Florida

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC; at least 1 extracranial measurable target lesion not previously irradiated. CNS metastases allowed if asymptomatic and not currently requiring corticosteroid treatment.
Availability of an archival FFPE tissue specimen.
No prior systemic NSCLC treatment.
ECOG PS 0, 1, or 2.
Age ≥18 years .
Adequate Bone Marrow, Liver, Renal, Pancreatic Function
Negative pregnancy test for females of childbearing potential

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Spinal cord compression unless good pain control attained
Major surgery within 4 weeks prior to randomization.
Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Whole brain irradiation within 4 weeks prior to randomization
Active bacterial, fungal, or viral infection
Clinically significant cardiovascular disease, active or within 3 months prior to enrollment. Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation, bradycardia or congenital long QT syndrome
Predisposing characteristics for acute pancreatitis in the last month prior to randomization.
History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease
Active malignancy (other than NSCLC, non melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, LCIS/DCIS of the breast, or localized prostate cancer) within the last 3 years prior to randomization.
Concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib.
known strong CYP3A inhibitors .
known strong CYP3A inducers

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (166 Sites)

Showing the first 25 of 166 sites.

Florida Cancer Specialists — Altamonte Springs, Florida
Florida Cancer Specialists — Brandon, Florida
Florida Cancer Specialists — Clearwater, Florida
Florida Cancer Specialists — Gainesville, Florida
Florida Cancer Specialists — Largo, Florida
Florida Cancer Specialists — Lecanto, Florida
Florida Cancer Specialists — Orange City, Florida
Florida Cancer Specialists — Orlando, Florida
Florida Cancer Specialists — Spring Hill, Florida
Florida Cancer Specialists — St. Petersburg, Florida
Florida Cancer Specialists — Tampa, Florida
Florida Cancer Specialists — Tavares, Florida
Florida Cancer Specialists — The Villages, Florida
Florida Cancer Specialists — Winter Park, Florida
Massachusetts Eye and Ear Infirmary — Boston, Massachusetts
Massachusetts General Hospital — Boston, Massachusetts
Ophthalmic Consultants of Boston Inc — Boston, Massachusetts
The William P. Beetham Eye Institute, Joslin Diabetes Center — Boston, Massachusetts
University of Rochester Cancer Center Pharmacy — Rochester, New York
University of Rochester Medical Center — Rochester, New York
Tennessee Oncology, PLLC — Dickson, Tennessee
Tennessee Oncology, PLLC — Franklin, Tennessee
Tennessee Oncology, PLLC — Gallatin, Tennessee
Tennessee Oncology, PLLC — Hermitage, Tennessee
Tennessee Oncology, PLLC — Lebanon, Tennessee

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗