Lorlatinib Continuation Study

Pfizer

Status and phase: Active, not recruiting; Phase 4

Conditions: Non-Small-Cell Lung Cancer; NSCLC

Treatments: Drug: Lorlatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05144997

B7461039

2023-508952-21-00 (Registry Identifier)

2021-005569-42 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

2- Participants must agree to follow the reproductive criteria. 3- Adequate Bone Marrow, Liver, Renal, Pancreatic Function

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Lorlatinib

Experimental group

Description:

Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously

Treatment:

Drug: Lorlatinib