Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000056

EU PAS number

EUPAS1000000056

Study ID

1000000056

Official title and acronym

Comparative effectiveness of sotorasib versus docetaxel in second line and beyond (2L+) among patients with advanced non-small cell lung cancer (NSCLC) in the Flatiron Health (FH) Enhanced Datamart (EDM)

DARWIN EU® study

No

Study countries

United States

Study description

To compare overall survival in KRAS G12C advanced NSCLC patients initiating treatment with sotorasib monotherapy versus docetaxel monotherapy or combination therapy in 2L setting.

Study status

Ongoing
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 interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
No external funding
Regulatory

Was the study required by a regulatory body?

No

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

Non-EU RMP only