Comparative Effectiveness of Sotorasib Versus Docetaxel Monotherapy in Second Line and Beyond (2L+) Among Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) in the Cancer Analysis System Database in England (20240164)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000405
• EU PAS number:
  EUPAS1000000405
• Study ID:
  1000000405
• Official title and acronym:
  Comparative Effectiveness of Sotorasib Versus Docetaxel Monotherapy in Second Line and Beyond (2L+) Among Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) in the Cancer Analysis System Database in England (20240164)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 22/05/2024

Actual: 22/05/2024

Study start date

Planned: 10/12/2024

Actual: 10/12/2024

Data analysis start date

Planned: 17/03/2025

Actual: 17/03/2025

Date of final study report

Planned: 30/09/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

This study is being funded by Amgen Inc.

Study protocol

Initial protocol

Protocol-Published Original sotorasib 20240164 (2).pdf

Regulatory

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

Other study registration identification numbers and links

20240164