Lorlatinib Continuation Study

May 1, 2024 updated by: Pfizer

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100000
        • Not yet recruiting
        • University Cancer Hospital
      • Shanghai, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
    • Beijing
      • Beijing, Beijing, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • Jilin Cancer Hospital
      • Changchun, Jilin, China, 130028
        • Not yet recruiting
        • Jilin Cancer Hospital
    • Qiantang District
      • Hangzhou, Qiantang District, China, 310016
        • Not yet recruiting
        • Sir Run Shaw Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Not yet recruiting
        • Shanghai Chest Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Sichuan cancer hospital
  • France
      • Rennes, France, 35033
        • Recruiting
        • CHU de Rennes - Hôpital Pontchaillou
      • Villejuif Cedex, France, 94805
        • Recruiting
        • Institut Gustave Roussy
  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital
  • Singapore
      • Singapore, Singapore, 169610
        • Recruiting
        • National Cancer Centre Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital
      • Singapore, Singapore, 168583
        • Active, not recruiting
        • National Cancer Centre Singapore
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
    • Cataluña
      • Barcelona, Cataluña, Spain, 08035
        • Recruiting
        • Hospital Vall D´Hebron
  • Taiwan
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
  • United States
    • California
      • Orange, California, United States, 92868-3201
        • Recruiting
        • UC Irvine Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • PF-06463922

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline up to approximately 5 years
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
Baseline up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2021

Primary Completion (Estimated)

December 28, 2026

Study Completion (Estimated)

December 28, 2026

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7461039
  • 2021-005569-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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