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
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 
Study protocol
Initial protocol
English (436.79 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable