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



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:April 14, 2017
End Date:February 1, 2024
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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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

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


Inclusion Criteria:

- 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

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.

1. known strong CYP3A inhibitors .

2. known strong CYP3A inducers

3. known P gp substrates with a narrow therapeutic index

- Concurrent use of CYP3A substrates with narrow therapeutic indices within 12 days
prior to the first dose of lorlatinib or crizotinib.

- Other severe acute or chronic medical or psychiatric condition, including recent or
active suicidal ideation or behavior, or laboratory abnormality that may increase the
risk associated with study participation or interfere with the interpretation of study
results

- Investigational site staff members directly involved in the conduct of the study and
their family members, or Pfizer employees, including their family members, directly
involved in the conduct of the study.

- Participation in other studies involving investigational drug(s) within 2 weeks prior
to study entry and/or during study participation.
We found this trial at
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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601 East Altamonte Drive
Altamonte Springs, Florida 32701
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243 Charles St
Boston, Massachusetts 02114
(617) 523-7900
Massachusetts Eye & Ear Infirmary Whether you see our physicians at Mass. Eye and Ear's...
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Boston, Massachusetts 02114
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1 Joslin Place
Boston, Massachusetts 02215
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403 South Kings Avenue
Brandon, Florida 33511
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3280 McMullen Booth Road
Clearwater, Florida 33761
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Dickson, Tennessee 37055
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Franklin, Tennessee 37067
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Gainesville, Florida
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Gallatin, Tennessee 37066
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Hermitage, Tennessee 37076
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1301 2nd Avenue Southwest
Largo, Florida 33770
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Lebanon, Tennessee 37087
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521 North Lecanto Highway
Lecanto, Florida 34461
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Murfreesboro, Tennessee 37130
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New Port Richey, Florida 34655
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1630 Southeast 18th Street
Ocala, Florida 34471
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765 Image Way
Orange City, Florida 32763
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Orlando, Florida 32806
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1115 Avenida de Mayo
Pergamino, Buenos Aires
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Saint Petersburg, Florida 33705
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Shelbyville, Tennessee 37160
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Smyrna, Tennessee 37167
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Spring Hill, Florida 34608
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3402 West Doctor Martin Luther King Junior Boulevard
Tampa, Florida 33607
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4100 Waterman Way
Tavares, Florida 32778
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1400 U.S. 441
The Villages, Florida 32159
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2100 Glenwood Drive
Winter Park, Florida 32792
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