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Trial record 1 of 1 for:    b7461020
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Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03178071
Expanded Access Status : No longer available
First Posted : June 6, 2017
Last Update Posted : November 4, 2019
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer ALK Positive or ROS1 Positive Drug: 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, however Basic Results will not be posted. This statement has been placed in the Detailed Description section of the protocol registration on

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Study Type : Expanded Access
Expanded Access Type : Individual Patients

Resource links provided by the National Library of Medicine

Drug Information available for: Lorlatinib

Intervention Details:
  • Drug: Lorlatinib
    oral tablets, administered daily, continuously
    Other Name: PF-06463922

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03178071

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT03178071    
Other Study ID Numbers: B7461020
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Keywords provided by Pfizer:
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms