NCT04362072

Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer

Single-Arm Study of Lorlatinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) Whose Disease Progressed After One Prior Second-Generation ALK Tyrosine Kinase Inhibitor (TKI)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to learn whether the study medicine (called lorlatinib) is safe and effective for the treatment of non-small cell lung cancer that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene. This study is seeking participants whose lung cancer has progressed after receiving either alectinib or ceritinib as their first treatment. Participants will take part in this study for up to approximately 4 years, depending on when the study is completed and how their cancer responds to the study treatment. They will take lorlatinib orally (by mouth) once daily. Participants will visit the study site about every six weeks to meet with the study team. During these visits, the study team will monitor the safety and effects of lorlatinib.

Conditions

• Carcinoma
• Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Lorlatinib	25 milligram (mg) tablet

Timeline

• Start date: 2020-09-29
• Primary completion: 2024-05-29
• Completion: 2024-10-23
• First posted: 2020-04-24
• Last updated: 2025-06-11
• Results posted: 2025-06-11

Locations

31 sites across 7 countries: United States, India, Italy, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study