Non Small Cell Lung Cancer ALK Positive or ROS1 PositiveNCT03178071
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
A study testing Lorlatinib in people with Non Small Cell Lung Cancer ALK Positive or ROS1 Positive, run by Pfizer at 49 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
- What is being tested?
- Lorlatinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 49 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
University Cancer & Blood Center, Llc
Athens, Georgia, 30607
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute/Pharmacy
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29414
University of Chicago Medical Center, CCD
Chicago, Illinois, 60637
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, 63376
Ohio State University East Hospital
Columbus, Ohio, 43205
The Ohio State University Investigational Drug Services
Columbus, Ohio, 43210
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210
The Ohio State University
Columbus, Ohio, 43210
Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
The Ohio State University Martha Morehouse Medical Plaza
Columbus, Ohio, 43221
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
Henry Ford Hospital
Detroit, Michigan, 48202
North Shore Hematology Oncology Associates
East Setauket, New York, 11733
Elmhurst Memorial Hospital Nancy W. Knowles Cancer Center
Elmhurst, Illinois, 60126
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
CarePoint Gahanna
Gahanna, Ohio, 43230
Pacific Shores Medical Group
Huntington Beach, California, 92648
Pacific Shores Medical Group
Irvine, California, 92618
Pacific Shores Medical Group
Long Beach, California, 90808
Pacific Shores Medical Group
Long Beach, California, 90813
Edward Cancer Center
Naperville, Illinois, 60540
Rutgers Cancer Institute Of New Jersey
New Brunswick, New Jersey, 08903
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
Breast and Imaging Center - 12th floor
New York, New York, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Kaiser Permanente, Oakland Medical Center
Oakland, California, 94611
UC Irvine Health / Chao Family Comprehensive Cancer Center
Orange, California, 92868
University of California Irvine/Chao Family Comprehensive Cancer Center
Orange, California, 92868
North Shore Hematology Oncology Associates
Patchogue, New York, 11772
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, 33028
UPMC Hillman Cancer Center - Patient Clinic
Pittsburgh, Pennsylvania, 15232
North Shore Hematology Oncology Associates
Port Jefferson Station, New York, 11776
Kaiser Permanente, South Sacramento Medical Center
Sacramento, California, 95823
Kaiser Permanente, San Francisco Medical Center
San Francisco, California, 94115
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, 86336
Washington University School of Medicine
St Louis, Missouri, 63110
Siteman Cancer Center - South County
St Louis, Missouri, 63129
Kaiser Permanente, Vallejo Medical Center
Vallejo, California, 94589
About this study
Official title: AN EXPANDED ACCESS PROTOCOL FOR LORLATINIB FOR TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS
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
Read the 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.
- Being tested
- Lorlatinib
- Keywords
- NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorlatinibDrug
Also called PF-06463922
oral tablets, administered daily, continuously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer ALK Positive or ROS1 PositiveStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178071
- Sponsor's protocol ID
- B7461020
- Status last verified
- Oct 2019
- First submitted
- 2 Jun 2017
- Last updated
- 4 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN EXPANDED ACCESS PROTOCOL FOR LORLATINIB FOR TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS
- ClinicalTrials.gov ID
- NCT03178071
- Acronym / sponsor ID
- B7461020
- Keywords
- NSCLC
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorlatinibAlso: PF-06463922oral tablets, administered daily, continuously | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lorlatinib in people with Non Small Cell Lung Cancer ALK Positive or ROS1 Positive, run by Pfizer at 49 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.