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Lorlatinib Continuation Study

StatusActive, Not Recruiting
PhasePhase 4
SponsorPfizer
Started2021-12-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 33 months later Dec 28, 2026 → Oct 25, 2029
See other at-risk trials from Pfizer

Amendment history

2026-09-24
Primary completion pushed: 2026-12-28 → 2029-10-25
Completion pushed: 2026-12-28 → 2029-10-25
2026-08-25
Study Status v22
Re-verified, no change to tracked fields
2025-12-11
Study Identification, Study Status, Study Design, Contacts/Locations v21
Enrollment target74→76
Study sites35→27
2024-11-11
Study Status, Study Design v20
Enrollment target73→74
2024-10-08
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v19
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 200→confirmed 73
Study sites35 entries, revised
JilinThe CancerSecond Affiliated Hospital of Zhejiang University College of Medicine SichuanBhaktivedanta CancerHospital hospital& Research Institute
Show 18 earlier versions
2024-09-04
Study Status, Contacts/Locations v18
Study sites33→35
2024-08-26
Study Identification, Study Status, Contacts/Locations v17
Study sites31→33
2024-07-23
Study Status, Contacts/Locations v16
Study sites30→31
2024-07-01
Study Status, Contacts/Locations v15
Study sites28→30
2024-06-24
Study Status, Contacts/Locations v14
Study sitesdetails revised at 2 of 28 sites
2024-05-31
Study Status, Contacts/Locations v13
Study sites20→28
2024-05-01
Study Status, Contacts/Locations v12
Primary completion date2027-06-12→2026-12-28
Completion date2027-06-12→2026-12-28
Study sites17→20
2024-03-29
Study Status, Contacts/Locations v11
Primary completion date2026-12-28→2027-06-12
Completion date2026-12-28→2027-06-12
Study sites10→17
2023-08-04
Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 10 sites
2023-03-23
Study Status, Contacts/Locations v9
Study sites9→10
2023-02-22
Study Status, Contacts/Locations v8
Study sites8→9
2023-01-10
Study Status, Contacts/Locations v7
Study sites7→8
2022-12-07
Study Status, Contacts/Locations v6
Study sites6→7
2022-10-17
Study Status, Contacts/Locations v5
Study sites4→6
2022-09-16
Study Status, Eligibility, Contacts/Locations v4
Study sites3→4
Eligibility criteria-111 characters
[...] Investigator) in a Pfizer-sponsored Lorlatinib Parent Study with no ongoing NCI CTCAE Grade ≥3 or intolerable Grade 2 AEs considered to be related to lorlatinib treatment. 2- Participants must agree to follow the reproductive crit [...]
2022-07-21
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 3 sites
2022-05-27
Study Status, Contacts/Locations v2
Study sites1→3
2022-01-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-12-31→2026-12-28
Completion date2026-12-31→2026-12-28
Start dateestimated 2021-12-31→confirmed 2021-12-28
Study sites0→1
2021-11-22
Original filing
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
Trial Details
NCT Number NCT05144997
Lead Sponsor Pfizer
Conditions Non-Small-Cell Lung Cancer, NSCLC
Enrollment 76 participants
Start Date 2021-12-28
Primary Completion 2029-10-25 (estimated)
Study Completion 2029-10-25 (estimated)
Updated on ClinicalTrials.gov 2026-09-23