Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
AN EXPANDED ACCESS PROTOCOL FOR LORLATINIB FOR TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS
1 other identifier
expanded_access
N/A
1 country
49
Brief Summary
This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 6, 2017
CompletedNovember 4, 2019
October 1, 2019
June 2, 2017
October 31, 2019
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Ineligibility for participation in any ongoing clinical study of the investigational product
- Age ≥18 years
- Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK rearrangement or a ROS1 rearrangement
- For ALK positive patients: failure to prior treatment with at least one ALK-TKI. If prior ALK-TKI was crizotinib, additional prior treatment required with at least one second generation ALK-TKI registered and commercially available. For patients with resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance mutation), prior treatment with an ALK/ROS1 inhibitor is not required.
- For ROS1 positive patients: failure to prior treatment with at least crizotinib
- Adequate bone marrow, liver, renal, pancreatic functions
- Negative pregnancy test at screening
You may not qualify if:
- Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or participation in other studies with investigational drugs within the timeframe indicated in the protocol
- History of interstitial fibrosis or interstitial lung disease
- Concomitant use of prohibited medication
- Clinically significant cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, second degree or third degree atrioventricular block (unless paced) or any AV block with PR \>220 msec
- Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with QTc \>470 msec, or congenital long QT syndrome
- History of or predisposing characteristics for acute pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (49)
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, 86336, United States
Pacific Shores Medical Group
Huntington Beach, California, 92648, United States
Pacific Shores Medical Group
Irvine, California, 92618, United States
Pacific Shores Medical Group
Long Beach, California, 90808, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Kaiser Permanente, Oakland Medical Center
Oakland, California, 94611, United States
UC Irvine Health / Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
University of California Irvine/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Kaiser Permanente, South Sacramento Medical Center
Sacramento, California, 95823, United States
Kaiser Permanente, San Francisco Medical Center
San Francisco, California, 94115, United States
Kaiser Permanente, Vallejo Medical Center
Vallejo, California, 94589, United States
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
University Cancer & Blood Center, Llc
Athens, Georgia, 30607, United States
University of Chicago Medical Center, CCD
Chicago, Illinois, 60637, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Elmhurst Memorial Hospital Nancy W. Knowles Cancer Center
Elmhurst, Illinois, 60126, United States
Edward Cancer Center
Naperville, Illinois, 60540, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute/Pharmacy
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
Rutgers Cancer Institute Of New Jersey
New Brunswick, New Jersey, 08903, United States
North Shore Hematology Oncology Associates
East Setauket, New York, 11733, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10022, United States
Breast and Imaging Center - 12th floor
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
North Shore Hematology Oncology Associates
Patchogue, New York, 11772, United States
North Shore Hematology Oncology Associates
Port Jefferson Station, New York, 11776, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Ohio State University East Hospital
Columbus, Ohio, 43205, United States
The Ohio State University Investigational Drug Services
Columbus, Ohio, 43210, United States
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212, United States
The Ohio State University Martha Morehouse Medical Plaza
Columbus, Ohio, 43221, United States
CarePoint Gahanna
Gahanna, Ohio, 43230, United States
UPMC Hillman Cancer Center - Patient Clinic
Pittsburgh, Pennsylvania, 15232, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29414, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 6, 2017
Last Updated
November 4, 2019
Record last verified: 2019-10