Tarlatamab vs. Real-world Physicians’ Choice Therapies in Patients with Relapsed or Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment: Patient-level Indirect Treatment Comparison (ITC) of DeLLphi-301 vs. Flatiron Real-world Data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000298
• EU PAS number:
  EUPAS1000000298
• Study ID:
  1000000298
• Official title and acronym:
  Tarlatamab vs. Real-world Physicians’ Choice Therapies in Patients with Relapsed or Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment: Patient-level Indirect Treatment Comparison (ITC) of DeLLphi-301 vs. Flatiron Real-world Data
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is an indirect treatment comparison study estimating the relative treatment effect of tarlatamab vs. real-world physician’s choice of therapy (RWPT). Efficacy data of tarlatamab was informed by the long-term follow-up data of the DeLLphi-301 trial (Oct 2023 data cutoff); while data of RWPT was obtained from an external control cohort created using the US Flatiron Health Research Database (Jan 2013 – Oct 2021).
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 03/04/2024

Actual: 03/04/2024

Study start date

Planned: 03/04/2024

Actual: 03/04/2024

Data analysis start date

Planned: 04/05/2024

Actual: 04/05/2024

Date of final study report

Planned: 31/08/2024

Actual: 05/08/2024

Sources of funding

Pharmaceutical company and other private sector 

Study protocol

Initial protocol

20240049_tarlatamab_Protocol-Published Amendment.pdf

Regulatory

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