Non-Small-Cell Lung Cancer, NSCLC
Conditions
Keywords
ALK, anaplastic lymphoma kinase
Brief summary
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
Interventions
DRUGLorlatinib
ALK-positive NSCL treatment
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events leading to permanent discontinuation of study intervention | Baseline up to approximately 5 years | Safety collection in this study will permit further characterization of the safety profile of lorlatinib |
| Number of serious adverse events reported for all participants | Baseline up to approximately 5 years | Safety collection in this study will permit further characterization of the safety profile of lorlatinib |
Countries
China, France, India, Japan, Singapore, Spain, Taiwan, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed