Prospective Observational Study on the Safety and Effectiveness of Imdelltra (tarlatamab) 20230176

Study identification

• EU PAS number:
  EUPAS1000000778
• Study ID:
  1000000778
• Official title and acronym:
  Prospective Observational Study on the Safety and Effectiveness of Imdelltra (tarlatamab) 20230176
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  20230176 is regulatory mandated prospective observational multicenter study in patients who are prescribed tarlatamab within the approved indication (small cell lung cancer (SCLC)) in a post-marketing setting in South Korea. The primary objective of the study is to evaluate safety and effectiveness of tarlatamab in real world clinical practice.
• Study status:
  Planned

Research institutions and networks

Institutions

Amgen

United States

DreamCIS

Study timelines

Date when funding contract was signed

Planned:16/09/2025

Actual:16/10/2025

Study start date

Planned:15/12/2025

Data analysis start date

Planned:16/02/2030

Date of interim report, if expected

Planned:15/07/2026

Date of final study report

Planned:15/07/2030

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only