Observational study to investigate safety and effectiveness of lorlatinib as first line treatment for ALK-gene rearranged unresectable advanced/recurrent NSCLC patients in Japan clinical setting

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000117
• EU PAS number:
  EUPAS1000000117
• Study ID:
  1000000117
• Official title and acronym:
  Observational study to investigate safety and effectiveness of lorlatinib as first line treatment for ALK-gene rearranged unresectable advanced/recurrent NSCLC patients in Japan clinical setting
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The overall objective is to describe special interested AEs with information regarding dose modification, and effectiveness of lorlatinib as first line treatment in clinical setting in Japan.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 12/04/2024

Actual: 12/04/2024

Study start date

Planned: 14/04/2024

Actual: 27/05/2024

Date of final study report

Planned: 31/08/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

Non-Interventional Study Protocol_Ver1.0_reducted.pdf

Updated protocol

Non-Interventional Study Protocol_Ver2.0_reducted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable