Trials / Active Not Recruiting
Active Not RecruitingNCT05144997
Lorlatinib Continuation Study
LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES
- Status
- Active Not Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lorlatinib | ALK-positive NSCL treatment |
Timeline
- Start date
- 2021-12-28
- Primary completion
- 2026-12-28
- Completion
- 2026-12-28
- First posted
- 2021-12-06
- Last updated
- 2025-12-17
Locations
27 sites across 8 countries: United States, China, France, India, Japan, Singapore, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05144997. Inclusion in this directory is not an endorsement.