NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2041210127

Registered date:09/01/2022

Lorlatinib Continuation Study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studied*Non-Small-Cell Lung Cancer *NSCLC
Date of first enrollment28/12/2021
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Drug: Lorlatinib ALK-positive NSCL treatment Other Name: PF-06463922

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaInclusion 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 criteriaExclusion 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

Contact

Public contact
Name Clinical Trials Information Desk
Address Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo Tokyo Japan 151-8589
Telephone +81-3-5309-7000
E-mail clinical-trials@pfizer.com
Affiliation Pfizer R&D Japan G.K.
Scientific contact
Name Norisuke Kawai
Address Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo Tokyo Japan 151-8589
Telephone +81-3-5309-7000
E-mail clinical-trials@pfizer.com
Affiliation Pfizer R&D Japan G.K.