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NCT04362072 · ClinicalTrials.gov registry record · Phase 4
Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
NCT04362072: Completed Phase 4 study, sponsored by Pfizer.
NCT04362072 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 71 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04362072, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
Study 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.
Primary Outcome
Confirmed OR based on ICR assessment was defined as complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumor (RECIST) version(v)1.1 from date of first dose until documented progressive disease (PD) or start of new anti-cancer therapy without regard to discontinuation from treatment. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after criteria for response are first met. CR: disappearance of all target and non
Interventions
- DRUG Lorlatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2020-09-29 |
| Est. Completion | 2024-10-23 |
| Phase | Phase 4 |
What the finished NCT04362072 record still lists
NCT04362072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Lorlatinib is the first listed.
NCT04362072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04362072 about?
NCT04362072 is a clinical study titled "Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer". 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 progresse...
What is the current status of trial NCT04362072?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2020-09-29. Estimated completion is 2024-10-23.
What interventions are being tested in trial NCT04362072?
The interventions under investigation include: Lorlatinib (DRUG).
Who is sponsoring clinical trial NCT04362072?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04362072's enrollment target sits among peer trials
71 1040th of 2000 higher than 958 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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