Lorlatinib Continuation Study

Running, not enrolling · Phase 4

Conditions studied: Non-Small-Cell Lung Cancer, NSCLC

In brief

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

Key facts

Study ID

NCT05144997

Run by

Pfizer

People needed

76

Starts

2021-12-28

Expected to finish

2026-12-28

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
• The First affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
• Beijing Chest Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China
• Fujian Cancer Hospital — Fuzhou, Fujian, China
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China
• Hunan Provincial Tumor Hospital — Changsha, Hunan, China
• General Hospital of Eastern Theater Command — Nanjing, Jiangsu, China
• Jilin Cancer Hospital — Changchun, Jilin, China
• The first hospital of jilin university — Changchun, Jilin, China
• Sir Run Shaw Hospital — Hangzhou, Qiantang District, China
• The Second Affiliated Hospital of PLA Air Force Medical University — Xi'an, Shaanxi, China
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China
• Sichuan Cancer hospital — Chengdu, Sichuan, China
• The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China
• The Second Affiliated Hospital of Zhejiang University College of Medicine — Hangzhou, Zhejiang, China
• Fudan University Shanghai Cancer Center — Shanghai, China
• CHU de Rennes - Hôpital Pontchaillou — Rennes, France
• Institut Gustave Roussy — Villejuif, France
• Healthcare Global Enterprises — Bengaluru, Karnataka, India
• Bhaktivedanta Hospital & Research Institute — Thane, Maharashtra, India
• Aichi Cancer Center Hospital — Nagoya, Aichi-ken, Japan
• National University Hospital — Singapore, Singapore
• National Cancer Centre Singapore — Singapore, Singapore

Full record on ClinicalTrials.gov

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