N/A
Completed N=73
A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled
Source: ClinicalTrials.gov NCT06282991 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Number of Participants According to First Line Therapy Treatment Pattern From Initial Diagnosis to Current Lorlatinib Treatment — 25; 3; 40; 2 Participants
Summary
The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled.
This study is seeking participants who:
* have lung cancer that could not be controlled.
* have a type of gene called anaplastic lymphoma kinase. A gene is a part of your DNA that has instructions for making things your body needs to work.
* have received at least 1 treatment before.
All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take dacomitinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants According to First Line Therapy Treatment Pattern From Initial Diagnosis to Current Lorlatinib Treatment |
25; 3; 40; 2; 3 | — |
| PRIMARY Objective Response Rate (ORR) During Lorlatinib Treatment |
25.0 | — |
| PRIMARY Overall Survival |
19.6 | — |
| PRIMARY Progression Free Survival (PFS) For Lorlatinib Treatment |
15.4 | — |
| PRIMARY 1-year OS Rate on Lorlatinib |
79.0 | — |
| PRIMARY Time to Treatment Failure (TTF) for All NSCLC Treatment |
7.3 | — |
| PRIMARY TTF for Lorlatinib Treatment Failure |
6.7 | — |
| PRIMARY Number of Participants With Common Adverse Drug Reaction (ADRs) |
43; 2; 2; 5; 6; 9 | — |
| PRIMARY Duration of Common ADRs |
18.1; 17.9; 14.7; 17.4; 10.8; 19.7 | — |
| PRIMARY Number of Participants According to Severity of Common ADRs |
12; 26; 4; 1; 0; 0 | — |
| PRIMARY Number of Participants According to Type of Outcome of Common ADRs |
9; 2; 2; 29; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 20 years old
- Patients who were approved to join Lorlatinib CUP on or before 31 Jul 2019 while initiate Lorlatinib treatment before 30 Sep 2019,
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria
- Patient treated Lorlatinib other than CUP.
Data sourced from ClinicalTrials.gov (NCT06282991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.