Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
- Conditions
- Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
- Registration Number
- NCT03178071
- Lead Sponsor
- Pfizer
- 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
- Detailed Description
Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol B7461020 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted. This statement has been placed in the Detailed Description section of the protocol registration on ClinicalTrials.gov.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Memorial Cancer Institute at Memorial Hospital West
🇺🇸Pembroke Pines, Florida, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
UC Irvine Health / Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Arizona Oncology Associates, PC - NAHOA
🇺🇸Sedona, Arizona, United States
Kaiser Permanente, Oakland Medical Center
🇺🇸Oakland, California, United States
University of California Irvine/Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Kaiser Permanente, Vallejo Medical Center
🇺🇸Vallejo, California, United States
Kaiser Permanente, South Sacramento Medical Center
🇺🇸Sacramento, California, United States
Kaiser Permanente, San Francisco Medical Center
🇺🇸San Francisco, California, United States
University Cancer & Blood Center, Llc
🇺🇸Athens, Georgia, United States
University of Chicago Medical Center, CCD
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Edward Cancer Center
🇺🇸Naperville, Illinois, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
🇺🇸Farmington Hills, Michigan, United States
Siteman Cancer Center - West County
🇺🇸Creve Coeur, Missouri, United States
Siteman Cancer Center - St Peters
🇺🇸Saint Peters, Missouri, United States
North Shore Hematology Oncology Associates
🇺🇸Port Jefferson Station, New York, United States
Siteman Cancer Center - South County
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Ohio State University East Hospital
🇺🇸Columbus, Ohio, United States
The Ohio State University Investigational Drug Services
🇺🇸Columbus, Ohio, United States
Breast and Imaging Center - 12th floor
🇺🇸New York, New York, United States
CarePoint Gahanna
🇺🇸Gahanna, Ohio, United States
The Ohio State University James Cancer Hospital
🇺🇸Columbus, Ohio, United States
Stefanie Spielman Comprehensive Breast Center
🇺🇸Columbus, Ohio, United States
The Ohio State University Martha Morehouse Medical Plaza
🇺🇸Columbus, Ohio, United States
Charleston Hematology Oncology Associates, PA
🇺🇸Charleston, South Carolina, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
UPMC Hillman Cancer Center - Patient Clinic
🇺🇸Pittsburgh, Pennsylvania, United States
Rutgers Cancer Institute Of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute/Pharmacy
🇺🇸Boston, Massachusetts, United States
Elmhurst Memorial Hospital Nancy W. Knowles Cancer Center
🇺🇸Elmhurst, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States