Lorlatinib Continuation Study
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
2 other identifiers
interventional
76
8 countries
27
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2021
Longer than P75 for phase_4
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2021
CompletedFirst Posted
Study publicly available on registry
December 6, 2021
CompletedStudy Start
First participant enrolled
December 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 28, 2026
December 17, 2025
December 1, 2025
5 years
November 22, 2021
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with adverse events leading to permanent discontinuation of study intervention
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
Safety collection in this study will permit further characterization of the safety profile of lorlatinib
Baseline up to approximately 5 years
Study Arms (1)
Lorlatinib
EXPERIMENTALLorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously
Interventions
Eligibility Criteria
You may qualify if:
- Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study.
- Participants must agree to follow the reproductive criteria. 3- Adequate Bone Marrow, Liver, Renal, Pancreatic Function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (27)
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
The First affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410013, China
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210002, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
The first hospital of jilin university
Changchun, Jilin, 130021, China
Sir Run Shaw Hospital
Hangzhou, Qiantang District, 310016, China
The Second Affiliated Hospital of PLA Air Force Medical University
Xi'an, Shaanxi, 710038, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Sichuan Cancer hospital
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, Zhejiang, 310052, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
Institut Gustave Roussy
Villejuif, 94805, France
Healthcare Global Enterprises
Bengaluru, Karnataka, 560027, India
Bhaktivedanta Hospital & Research Institute
Thane, Maharashtra, 401107, India
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre Singapore
Singapore, 168583, Singapore
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
National Taiwan University Hospital
Taipei, 10002, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2021
First Posted
December 6, 2021
Study Start
December 28, 2021
Primary Completion (Estimated)
December 28, 2026
Study Completion (Estimated)
December 28, 2026
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
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.