Lorlatinib Continuation Study

JRCT ID: jRCT2041210127

Registered date:09/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: *Non-Small-Cell Lung Cancer *NSCLC
• Date of first enrollment: 28/12/2021
• Target sample size: 200
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

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

• Secondary Outcome: not aplicable

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT05144997