Effectiveness of LORlatinib as a Real-World, first-line treatment in ALK-positive Advanced Non-Small Cell Lung Cancer Patients in Germany. (LOR-ALK).

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000583
• Study ID:
  1000000583
• Official title and acronym:
  Effectiveness of LORlatinib as a Real-World, first-line treatment in ALK-positive Advanced Non-Small Cell Lung Cancer Patients in Germany. (LOR-ALK).
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Research Question:; This is an observational, prospective study to address the data gaps in the real world setting on effectiveness, safety and Quality of Life data of first line Lorlatinib treatment.; ; - What is the effectiveness and spectrum of adverse events, mitigation strategies and patient reported quality of life aspects associated with lorlatinib as a first line treatment in an ALK+ NSCLC real-world population in Germany.; Primary objectives:; - To describe the real-world Progression Free Survival (rwPFS) rate: RwPFS rate 12-months and 18-months.; - To describe Time to the next treatment defined as the period from the start of the treatment to the start of the next line of treatment.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:29/11/2024

Study start date

Planned:10/08/2026

Date of interim report, if expected

Planned:30/03/2027

Date of final study report

Planned:30/09/2030

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

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