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

Description

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 Start Date

April, 14 2017

Estimated Completion Date

October 2023

Interventions

  • Drug: Lorlatinib
  • Drug: Crizotinib

Study ID

Pfizer -- B7461006

Status

Recruiting

Trial ID

NCT03052608

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

280

Sponsor

Pfizer

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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (158)

Study Location Distance Name Phone Email
The William P Beetham Eye Institute Joslin Diabetes Center - Boston, Massachusetts 2.4 miles None None None
The William P Beetham Eye Institute Joslin Diabetes Center - Boston, Massachusetts 2.4 miles None None None
The William P Beetham Eye Institute Joslin Diabetes Center - Boston, Massachusetts 2.4 miles None None None
The William P Beetham Eye Institute Joslin Diabetes Center - Boston, Massachusetts 2.4 miles None None None
The William P Beetham Eye Institute Joslin Diabetes Center - Boston, Massachusetts 2.4 miles None None None
Massachusetts Eye and Ear Infirmary - Boston, Massachusetts 2.8 miles None None None
Ophthalmic Consultants of Boston Inc - Boston, Massachusetts 2.8 miles None None None
Ophthalmic Consultants of Boston Inc - Boston, Massachusetts 2.8 miles None None None
Ophthalmic Consultants of Boston Inc - Boston, Massachusetts 2.8 miles None None None
Ophthalmic Consultants of Boston Inc - Boston, Massachusetts 2.8 miles None None None
Massachusetts Eye and Ear Infirmary - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts Eye and Ear Infirmary - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
WVU Medicine Inpatient Pharmacy - Morgantown, West Virginia 501.0 miles None None None
West Virginia University - Morgantown, West Virginia 501.0 miles None None None
West Virginia University - Morgantown, West Virginia 501.0 miles None None None
WVU Clinical Trials Research Unit - Morgantown, West Virginia 501.0 miles None None None
WVU Clinical Trials Research Unit - Morgantown, West Virginia 501.0 miles None None None
WVU CTRU Co Biospecimen Processing Core - Morgantown, West Virginia 501.0 miles None None None
WVU Medicine Inpatient Pharmacy - Morgantown, West Virginia 501.0 miles None None None
WVU Clinical Trials Research Unit - Morgantown, West Virginia 501.0 miles None None None
WVU CTRU Co Biospecimen Processing Core - Morgantown, West Virginia 501.0 miles None None None
WVU CTRU Co Biospecimen Processing Core - Morgantown, West Virginia 501.0 miles None None None
West Virginia University - Morgantown, West Virginia 501.0 miles None None None
WVU Clinical Trials Research Unit - Morgantown, West Virginia 501.0 miles None None None
WVU CTRU Co Biospecimen Processing Core - Morgantown, West Virginia 501.0 miles None None None
WVU CTRU Co Biospecimen Processing Core - Morgantown, West Virginia 501.0 miles None None None
WVU Medicine Inpatient Pharmacy - Morgantown, West Virginia 501.0 miles None None None
West Virginia University - Morgantown, West Virginia 501.0 miles None None None
WVU Medicine Inpatient Pharmacy - Morgantown, West Virginia 501.0 miles None None None
WVU Medicine Inpatient Pharmacy - Morgantown, West Virginia 501.0 miles None None None
West Virginia University - Morgantown, West Virginia 501.0 miles None None None
WVU Clinical Trials Research Unit - Morgantown, West Virginia 501.0 miles None None None
Ohio State University East Hospital - Columbus, Ohio 640.0 miles None None None
Ohio State University East Hospital - Columbus, Ohio 640.0 miles None None None
Ohio State University East Hospital - Columbus, Ohio 640.0 miles None None None
Ohio State University East Hospital - Columbus, Ohio 640.0 miles None None None
Ohio State University East Hospital - Columbus, Ohio 640.0 miles None None None
The Ohio State University James Cancer Hospital - Columbus, Ohio 641.8 miles None None None
The Ohio State University James Cancer Hospital - Columbus, Ohio 641.8 miles None None None
The Ohio State University Wexner Medical Center Thoracic Oncology Clinic - Columbus, Ohio 641.8 miles None None None
The Ohio State University Wexner Medical Center Thoracic Oncology Clinic - Columbus, Ohio 641.8 miles None None None
The Ohio State University Wexner Medical Center Investigational Drug Services - Columbus, Ohio 641.8 miles None None None
The Ohio State University Wexner Medical Center Investigational Drug Services - Columbus, Ohio 641.8 miles None None None
The Ohio State University Wexner Medical Center Investigational Drug Services - Columbus, Ohio 641.8 miles None None None
The Ohio State University Wexner Medical Center Thoracic Oncology Clinic - Columbus, Ohio 641.8 miles None None None
The Ohio State University James Cancer Hospital - Columbus, Ohio 641.8 miles None None None
The Ohio State University James Cancer Hospital - Columbus, Ohio 641.8 miles None None None
The Ohio State University Wexner Medical Center Investigational Drug Services - Columbus, Ohio 641.8 miles None None None
The Ohio State University James Cancer Hospital - Columbus, Ohio 641.8 miles None None None
The Ohio State University Wexner Medical Center Investigational Drug Services - Columbus, Ohio 641.8 miles None None None
The Ohio State University Wexner Medical Center Thoracic Oncology Clinic - Columbus, Ohio 641.8 miles None None None
The Ohio State University Wexner Medical Center Thoracic Oncology Clinic - Columbus, Ohio 641.8 miles None None None
Ohio State Eye and Ear Institute - Columbus, Ohio 643.4 miles None None None
Ohio State Eye and Ear Institute - Columbus, Ohio 643.4 miles None None None
Ohio State Eye and Ear Institute - Columbus, Ohio 643.4 miles None None None
Ohio State Eye and Ear Institute - Columbus, Ohio 643.4 miles None None None
Ohio State Eye and Ear Institute - Columbus, Ohio 643.4 miles None None None
Ohio State Outpatient Care Upper Arlington - Columbus, Ohio 644.2 miles None None None
The Ohio State University Martha Morehouse Medical Plaza - Columbus, Ohio 644.2 miles None None None
The Ohio State University Martha Morehouse Medical Plaza - Columbus, Ohio 644.2 miles None None None
Ohio State Outpatient Care Upper Arlington - Columbus, Ohio 644.2 miles None None None
Ohio State Outpatient Care Upper Arlington - Columbus, Ohio 644.2 miles None None None
Ohio State Outpatient Care Upper Arlington - Columbus, Ohio 644.2 miles None None None
The Ohio State University Martha Morehouse Medical Plaza - Columbus, Ohio 644.2 miles None None None
Ohio State Outpatient Care Upper Arlington - Columbus, Ohio 644.2 miles None None None
The Ohio State University Martha Morehouse Medical Plaza - Columbus, Ohio 644.2 miles None None None
The Ohio State University Martha Morehouse Medical Plaza - Columbus, Ohio 644.2 miles None None None
Tennessee Oncology PLLC - Gallatin, Tennessee 918.5 miles None None None
Tennessee Oncology PLLC - Gallatin, Tennessee 918.5 miles None None None
Tennessee Oncology PLLC - Gallatin, Tennessee 918.5 miles None None None
Tennessee Oncology PLLC - Gallatin, Tennessee 918.5 miles None None None
Tennessee Oncology PLLC - Gallatin, Tennessee 918.5 miles None None None
Tennessee Oncology PLLC - Lebanon, Tennessee 920.6 miles None None None
Tennessee Oncology PLLC - Lebanon, Tennessee 920.6 miles None None None
Tennessee Oncology PLLC - Lebanon, Tennessee 920.6 miles None None None
Tennessee Oncology PLLC - Lebanon, Tennessee 920.6 miles None None None
Tennessee Oncology PLLC - Lebanon, Tennessee 920.6 miles None None None
Tennessee Oncology PLLC - Hermitage, Tennessee 932.8 miles None None None
Tennessee Oncology PLLC - Hermitage, Tennessee 932.8 miles None None None
Tennessee Oncology PLLC - Hermitage, Tennessee 932.8 miles None None None
Tennessee Oncology PLLC - Hermitage, Tennessee 932.8 miles None None None
Tennessee Oncology PLLC - Hermitage, Tennessee 932.8 miles None None None
Tennessee Oncology PLLC - Murfreesboro, Tennessee 936.8 miles None None None
Tennessee Oncology PLLC - Murfreesboro, Tennessee 936.8 miles None None None
Tennessee Oncology PLLC - Murfreesboro, Tennessee 936.8 miles None None None
Tennessee Oncology PLLC - Murfreesboro, Tennessee 936.8 miles None None None
Tennessee Oncology PLLC - Murfreesboro, Tennessee 936.8 miles None None None
Tennessee Oncology PLLC - Smyrna, Tennessee 936.9 miles None None None
Tennessee Oncology PLLC - Smyrna, Tennessee 936.9 miles None None None
Tennessee Oncology PLLC - Smyrna, Tennessee 936.9 miles None None None
Tennessee Oncology PLLC - Smyrna, Tennessee 936.9 miles None None None
Tennessee Oncology PLLC - Smyrna, Tennessee 936.9 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 939.7 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 939.7 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 939.7 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 939.7 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 939.7 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 942.5 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 942.5 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 942.5 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 942.5 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 942.5 miles None None None
The Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles None None None
The Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 942.8 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 942.8 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 942.8 miles None None None
The Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles None None None
The Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles None None None
The Sarah Cannon Research Institute - Nashville, Tennessee 942.8 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 942.8 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 942.8 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 948.2 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 948.2 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 948.2 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 948.2 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 948.2 miles None None None
Tennessee Oncology PLLC - Franklin, Tennessee 952.1 miles None None None
Tennessee Oncology PLLC - Franklin, Tennessee 952.1 miles None None None
Tennessee Oncology PLLC - Franklin, Tennessee 952.1 miles None None None
Tennessee Oncology PLLC - Franklin, Tennessee 952.1 miles None None None
Tennessee Oncology PLLC - Franklin, Tennessee 952.1 miles None None None
Tennessee Oncology PLLC - Shelbyville, Tennessee 953.7 miles None None None
Tennessee Oncology PLLC - Shelbyville, Tennessee 953.7 miles None None None
Tennessee Oncology PLLC - Shelbyville, Tennessee 953.7 miles None None None
Tennessee Oncology PLLC - Shelbyville, Tennessee 953.7 miles None None None
Tennessee Oncology PLLC - Shelbyville, Tennessee 953.7 miles None None None
Tennessee Oncology PLLC - Dickson, Tennessee 976.0 miles None None None
Tennessee Oncology PLLC - Dickson, Tennessee 976.0 miles None None None
Tennessee Oncology PLLC - Dickson, Tennessee 976.0 miles None None None
Tennessee Oncology PLLC - Dickson, Tennessee 976.0 miles None None None
Tennessee Oncology PLLC - Dickson, Tennessee 976.0 miles None None None
Florida Cancer Specialists - Altamonte Springs, Florida 1,109.7 miles None None None
Boca Raton Regional Hospital Lynn Cancer Institute - Boca Raton, Florida 1,221.8 miles None None None
Boca Raton Regional Hospital Lynn Cancer Institute - Boca Raton, Florida 1,221.8 miles None None None
MidAmerica Division Inc co Research Medical Center - Kansas City, Missouri 1,249.4 miles None None None
MidAmerica Division Inc co Research Medical Center - Kansas City, Missouri 1,249.4 miles None None None
MidAmerica Division Inc co Research Medical Center - Kansas City, Missouri 1,249.4 miles None None None
MidAmerica Division Inc co Research Medical Center - Kansas City, Missouri 1,249.4 miles None None None
MidAmerica Division Inc co Research Medical Center - Kansas City, Missouri 1,249.4 miles None None None
MidAmerica Division Inc co Menorah Medical Center - Overland Park, Kansas 1,255.8 miles None None None
MidAmerica Division Inc co Menorah Medical Center - Overland Park, Kansas 1,255.8 miles None None None
MidAmerica Division Inc co Menorah Medical Center - Overland Park, Kansas 1,255.8 miles None None None
MidAmerica Division Inc co Menorah Medical Center - Overland Park, Kansas 1,255.8 miles None None None
MidAmerica Division Inc co Menorah Medical Center - Overland Park, Kansas 1,255.8 miles None None None
University of Washington Medical Center - Seattle, Washington 2,487.7 miles None None None
University of Washington Medical Center - Seattle, Washington 2,487.7 miles None None None
University of Washington Medical Center - Seattle, Washington 2,487.7 miles None None None
University of Washington Medical Center - Seattle, Washington 2,487.7 miles None None None
University of Washington Medical Center - Seattle, Washington 2,487.7 miles None None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles None None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles None None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles None None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles None None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles None None None

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