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CompletedNCT03844464Updated Sep 4, 2025

Safety and Efficacy of Lorbrena

An observational study in Non-small Cell Lung Cancer, sponsored by Pfizer. Completed at 1 site in Japan. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Pfizer · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,290
Ages
0 Years and older
Sex
All
01

Study summary

To investigate the following matters under post-marketing use of Lorbrena in patients who received this drug

  1. Factors affecting the onset of central nervous system disorder
  2. Effect of Lorbrena in combination with CYP3A inducers on the onset of hepatic dysfunction
02

Conditions studied

  • Non-small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 1,290 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

683 patients

Inclusion criteria

  • All administered patients

Exclusion criteria

Exclusion Criteria:

  • Nothing
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,290 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence of adverse drug reactions of central nervous system disorder and hepatic dysfunction

    Time frame: 52 weeks

07

Study locations

1 site
  • 3-22-7, Yoyogi, Shibuya-ku
    Tokyo, 151-8589, Japan
08

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03844464
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 18, 2019
Start date
Jan 21, 2019
Primary completion
Jul 30, 2025
Completion
Jul 30, 2025
Last update
Sep 4, 2025

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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