This study is in progress, not accepting new patients

Lorlatinib Continuation Study

a study on Lung Cancer Non-Small Cell Lung Cancer ALK Positive

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Cathleen Park (uci)

Description

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

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

Keywords

Non-Small-Cell Lung Cancer, NSCLC, ALK, anaplastic lymphoma kinase, Non-Small-Cell Lung Carcinoma, lorlatinib

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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.

Locations

  • Chao Family Comprehensive Cancer Center and Ambulatory Care
    Irvine California 92612 United States
  • Aichi Cancer Center Hospital
    Nagoya Aichi-ken 464-8681 Japan

Lead Scientist at University of California Health

  • Cathleen Park (uci)
    Assistant Health Sciences Professor, Medicine, School of Medicine. Authored (or co-authored) 9 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT05144997
Phase
Phase 4 research study
Study Type
Interventional
Participants
About 76 people participating
Last Updated