Lorlatinib Continuation Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Lorlatinib: ALK-positive NSCL treatment

Study 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

Eligibility

Primary outcome measure(s)

• 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

Trial sites (27)