Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

NO_LONGER_AVAILABLE

Conditions studied: Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

In brief

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

Key facts

Study ID

NCT03178071

Run by

Pfizer

Last updated by the study team

2019-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Arizona Oncology Associates, PC - NAHOA — Sedona, Arizona, United States
• Pacific Shores Medical Group — Huntington Beach, California, United States
• Pacific Shores Medical Group — Irvine, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Kaiser Permanente, Oakland Medical Center — Oakland, California, United States
• UC Irvine Health / Chao Family Comprehensive Cancer Center — Orange, California, United States
• University of California Irvine/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Kaiser Permanente, South Sacramento Medical Center — Sacramento, California, United States
• Kaiser Permanente, San Francisco Medical Center — San Francisco, California, United States
• Kaiser Permanente, Vallejo Medical Center — Vallejo, California, United States
• Memorial Cancer Institute at Memorial Hospital West — Pembroke Pines, Florida, 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
• Elmhurst Memorial Hospital Nancy W. Knowles Cancer Center — Elmhurst, Illinois, United States
• Edward Cancer Center — Naperville, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute/Pharmacy — Boston, Massachusetts, 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

Full record on ClinicalTrials.gov

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