MedTrace Logo

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

NCT04362072 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-06-11

Study results available
· View outcomes & findings →

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

DRUG

Lorlatinib

25 milligram (mg) tablet

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2024-05-29
Completion
2024-10-23
FDA Drug
Yes

Countries

  • United States
  • India
  • Italy
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04362072 on ClinicalTrials.gov