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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 - Lorlatinib Continuation Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2041210127
Enrollment
200
Registered
2022-01-09
Start date
2021-12-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

*Non-Small-Cell Lung Cancer *NSCLC

Interventions

Drug: Lorlatinib ALK-positive NSCL treatment Other Name: PF-06463922

Sponsors

Kawai Norisuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1 - Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal 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 criteria. 3- Adequate Bone Marrow, Liver, Renal, Pancreatic Function

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1 - Female participants who are pregnant or breastfeeding. 2- Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Primary Outcome Measures : 1.Number of participants with adverse events leading to permanent discontinuation of study intervention

Secondary

MeasureTime frame
not aplicable

Countries

China, France, India, Japan, Singapore, Spain, Taiwan, United States

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026