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NCT05144997 Clinical Trial

Lorlatinib Continuation Study

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05144997
Other study ID # B7461039
Secondary ID 2021-005569-42
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 28, 2021
Est. completion date December 28, 2026

Study information
Verified date May 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 28, 2026
Est. primary completion date December 28, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lorlatinib
ALK-positive NSCL treatment

Locations
Country Name City State
China Beijing Cancer Hospital Beijing Beijing
China Beijing Chest Hospital, Capital Medical University Beijing Beijing
China Beijing Chest Hospital, Capital Medical University Beijing
China University Cancer Hospital Beijing
China Jilin Cancer Hospital Changchun Jilin
China Jilin Cancer Hospital Changchun Jilin
China The first hospital of jilin university Changchun City Jilin
China Hunan Cancer Hospital Changsha Hunan
China Sichuan Cancer Hospital Chengdu Sichuan
China Sichuan Cancer Hospital Chengdu Sichuan
China Fujian Cancer Hospital Fuzhou Fujian
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Sir Run Shaw Hospital Hangzhou Qiantang District
China The First affiliated Hospital of Anhui Medical University Hefei Anhui
China General Hospital of Eastern Theater Command Nanjing Jiangsu
China Fudan University Shanghai Cancer Center Shanghai
China Shanghai Chest Hospital Shanghai Shanghai
China The Second Affiliated Hospital of PLA Air Force Medical University Xi'an City Shaanxi
France CHU de Rennes - Hôpital Pontchaillou Rennes
France Institut Gustave Roussy Villejuif Cedex
Japan Aichi Cancer Center Hospital Nagoya Aichi
Singapore National Cancer Centre Singapore Singapore
Singapore National Cancer Centre Singapore Singapore
Singapore National University Hospital Singapore
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Vall D´Hebron Barcelona Cataluña
Taiwan National Taiwan University Hospital Taipei
United States UC Irvine Health Orange California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  China,  France,  Japan,  Singapore,  Spain,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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