Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
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
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 4, 2019 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Expanded Access
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Expanded Access
- Phase
- Not applicable
- Sponsor
- Pfizer
- Interventions being studied
- Drug: Lorlatinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Arizona Oncology Associates, PC - NAHOASedona, Arizona
- Pacific Shores Medical GroupHuntington Beach, California
- Pacific Shores Medical GroupIrvine, California
- Pacific Shores Medical GroupLong Beach, California
- Pacific Shores Medical GroupLong Beach, California
- Kaiser Permanente, Oakland Medical CenterOakland, California
- UC Irvine Health / Chao Family Comprehensive Cancer CenterOrange, California
- University of California Irvine/Chao Family Comprehensive Cancer CenterOrange, California
- Kaiser Permanente, South Sacramento Medical CenterSacramento, California
- Kaiser Permanente, San Francisco Medical CenterSan Francisco, California
- Kaiser Permanente, Vallejo Medical CenterVallejo, California
- Memorial Cancer Institute at Memorial Hospital WestPembroke Pines, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 4, 2019. Always confirm current availability with the study team.