Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05144997 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Lorlatinib Continuation Study

StatusActive, Not Recruiting
PhasePhase 4
SponsorPfizer
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 9 months later Dec 28, 2026 → Oct 25, 2029
See other at-risk trials from Pfizer

Record History

  1. Primary and study completion pushed from Dec 28, 2026 to Oct 25, 2029 Site details revised at 3 of 27 sites Show all 2 changesShow less
    • Site details revised at 3 of 27 sites
  2. Re-verified, no change to tracked fieldsv23
  3. Enrollment target: 74 to 76 Study sites: 35 to 27v22 Show all 2 changesShow less
    • Study sites: 35 to 27
  4. Enrollment target: 73 to 74v21
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 200 to confirmed 73 · Study sites revised (35)v20 Show all 3 changesShow less
    • Enrollment target: estimated 200 to confirmed 73
    • Study sites revised (35)

    See this version in full on ClinicalTrials.gov ↗

Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 33 to 35v19
  2. Study sites: 31 to 33v18
  3. Study sites: 30 to 31v17
  4. Study sites: 28 to 30v16
  5. Site details revised at 2 of 28 sitesv15
  6. Study sites: 20 to 28v14
  7. Study sites: 17 to 20 Primary and study completion dates: Jun 12, 2027 to Dec 28, 2026v13 Show all 2 changesShow less
    • Primary and study completion dates: Jun 12, 2027 to Dec 28, 2026
  8. Study sites: 10 to 17 Primary and study completion dates: Dec 28, 2026 to Jun 12, 2027v12 Show all 2 changesShow less
    • Primary and study completion dates: Dec 28, 2026 to Jun 12, 2027
  9. Site details revised at 1 of 10 sitesv11
  10. Study sites: 9 to 10v10
  11. Study sites: 8 to 9v9
  12. Study sites: 7 to 8v8
  13. Study sites: 6 to 7v7
  14. Study sites: 4 to 6v6
  15. Study sites: 3 to 4 Eligibility criteria shortened, about 19 wordsv5 Show all 2 changesShow less
    • Eligibility criteria shortened, about 19 words

    See this version in full on ClinicalTrials.gov ↗

  16. Site details revised at 1 of 3 sitesv4
  17. Study sites: 1 to 3v3
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary and study completion dates: Dec 31, 2026 to Dec 28, 2026 · Start date changed from estimate of Dec 31, 2021 to Dec 28, 2021v2 Show all 4 changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: Dec 31, 2026 to Dec 28, 2026
    • Start date changed from estimate of Dec 31, 2021 to Dec 28, 2021
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov