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

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: Active, not recruiting
• Conditions: NSCLC; Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: Lorlatinib

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100000
      • Beijing Chest Hospital, Capital Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Provincial Tumor Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • General Hospital of Eastern Theater Command
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130000
      • Jilin Cancer Hospital
  • Qiantang District
    • Hangzhou, Qiantang District, China, 310016
      • Sir Run Shaw Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • The Second Affiliated Hospital of PLA Air Force Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Shanghai Chest Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Sichuan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310052
      • The Second Affiliated Hospital of Zhejiang University College of Medicine
• France
  • Rennes, France, 35033
    • CHU de Rennes - Hôpital Pontchaillou
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• India
  • Karnataka
    • Bengaluru, Karnataka, India, 560027
      • Healthcare Global Enterprises
  • Maharashtra
    • Thāne, Maharashtra, India, 401107
      • Bhaktivedanta Hospital & Research Institute
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center Hospital
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 168583
    • National Cancer Centre Singapore
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
• United States
  • California
    • Irvine, California, United States, 92612
      • Chao Family Comprehensive Cancer Center and Ambulatory Care

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

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 (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: anaplastic lymphoma kinase; ALK
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; lorlatinib
• Other Study ID Numbers: B7461039; 2023-508952-21-00 (Registry Identifier: CTIS (EU))

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