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

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ClinicalTrials.gov Identifier: NCT03178071
Expanded Access Status : Available
First Posted : June 6, 2017
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
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

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 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 Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: An Expanded Access Protocol For Lorlatinib For Treatment Of Patients With Advanced Non-small Cell Lung Cancer Harboring Specific Molecular Alterations

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer


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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03178071


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 43 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03178071     History of Changes
Other Study ID Numbers: B7461020
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

Keywords provided by Pfizer:
NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms