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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


Description

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

Trial 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 Info

Organization

Pfizer


Primary Outcome

Number of participants with adverse events leading to permanent discontinuation of study intervention


Outcome Timeframe Baseline up to approximately 5 years

NCTID NCT05144997

Phases PHASE4

Primary Purpose TREATMENT

Start Date 2021-12-28

Completion Date 2026-12-28

Enrollment Target 200

Interventions

DRUG Lorlatinib

Locations Recruiting

UC Irvine Health

United States, California, Orange


The First affiliated Hospital of Anhui Medical University

China, Anhui, Hefei


Beijing Chest Hospital, Capital Medical University

China, Beijing, Beijing


Beijing Cancer Hospital

China, Beijing, Beijing


Fujian Cancer Hospital

China, Fujian, Fuzhou


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