An observational study to assess the effectiveness and safety of cemiplimab in patients with advanced non-small cell lung cancer (NSCLC) in routine clinical practice settings in Europe (CEMI-LUNG)

Study identification

• EU PAS number:
  EUPAS1000001128
• Study ID:
  1000001128
• Official title and acronym:
  An observational study to assess the effectiveness and safety of cemiplimab in patients with advanced non-small cell lung cancer (NSCLC) in routine clinical practice settings in Europe (CEMI-LUNG)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Italy

  Spain
• Study description:
  This study is focused on patients with non-small cell lung cancer (NSCLC) and have been prescribed a cemiplimab (Libtayo®) based treatment regimen under standard care. The goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with NSCLC.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Regeneron Pharmaceuticals

Study timelines

Date when funding contract was signed

Actual:20/12/2021

Study start date

Actual:26/10/2022

Data analysis start date

Planned:04/12/2028

Date of final study report

Planned:30/01/2029

Sources of funding

Other

More details on 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

Other study registration identification numbers and links

R2810-ONC-2325, NCT05363319, U1111-1275-9867