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)

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

Study timelines

Date when funding contract was signed

Planned: 03/01/2024

Actual: 15/01/2024

Study start date

Planned: 05/02/2024

Actual: 10/02/2024

Data analysis start date

Planned: 15/02/2024

Actual: 15/02/2024

Date of interim report, if expected

Planned: 30/06/2024

Date of final study report

Planned: 12/12/2025

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

Other study registration identification numbers and links

20230266