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Lorlatinib Continuation Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05144997
Recruitment Status : Recruiting
First Posted : December 6, 2021
Last Update Posted : September 19, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer NSCLC Drug: Lorlatinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES
Actual Study Start Date : December 28, 2021
Estimated Primary Completion Date : December 28, 2026
Estimated Study Completion Date : December 28, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Lorlatinib

Arm Intervention/treatment
Experimental: Lorlatinib
Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously
Drug: Lorlatinib
ALK-positive NSCL treatment
Other Name: PF-06463922




Primary Outcome Measures :
  1. Number of participants with adverse events leading to permanent discontinuation of study intervention [ Time Frame: Baseline up to approximately 5 years ]
    Safety collection in this study will permit further characterization of the safety profile of lorlatinib

  2. Number of serious adverse events reported for all participants [ Time Frame: Baseline up to approximately 5 years ]
    Safety collection in this study will permit further characterization of the safety profile of lorlatinib



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

1 - Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study.

2- Participants must agree to follow the reproductive criteria. 3- Adequate Bone Marrow, Liver, Renal, Pancreatic Function

Exclusion Criteria:

1 - Female participants who are pregnant or breastfeeding. 2- Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.


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): NCT05144997


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

Locations
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France
Gustave Roussy Not yet recruiting
Villejuif Cedex, France, 94805
Japan
Aichi Cancer Center Hospital Recruiting
Nagoya, Aichi, Japan, 464-8681
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05144997    
Other Study ID Numbers: B7461039
2021-005569-42 ( EudraCT Number )
First Posted: December 6, 2021    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
ALK
anaplastic lymphoma kinase
Additional relevant MeSH terms:
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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