Clinical trial NCT05144997: Lorlatinib Continuation Study
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Non-Small-Cell Lung Cancer
NSCLC
Keywords: ALK
anaplastic lymphoma kinase
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-12-06
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Number of participants with adverse events leading to permanent discontinuation of study intervention
timeFrame: Baseline up to approximately 5 years
measure: Number of serious adverse events reported for all participants
timeFrame: Baseline up to approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: Hefei
country: China
facility: The First affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: General Hospital of Eastern Theater Command
state: Jiangsu
city: Changchun City
country: China
facility: The first hospital of jilin university
state: Jilin
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Hangzhou
country: China
facility: Sir Run Shaw Hospital
state: Qiantang District
city: Xi'an City
country: China
facility: The Second Affiliated Hospital of PLA Air Force Medical University
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College of Medicine
state: Zhejiang
city: Beijing
country: China
facility: University Cancer Hospital
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Pontchaillou
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Bengaluru
country: India
facility: Healthcare Global Enterprises
state: Karnataka
city: Thane/Mumbai
country: India
facility: Bhakti Vedanta Hospital & Research Institute
state: Maharashtra
city: Thane
country: India
facility: Bhaktivedanta Hospital & Research Institute
state: Maharashtra
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Barcelona
country: Spain
facility: Hospital Vall D´Hebron
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: