Lorlatinib Continuation Study

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

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

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, Lung Neoplasms, 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

  • UC Irvine Health accepting new patients
    Orange California 92868-3201 United States
  • Aichi Cancer Center Hospital accepting new patients
    Nagoya Aichi 464-8681 Japan

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT05144997
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated
Contact us about this trial