Special Drug Use-Results Surveillance (all-case) for sotorasib in patients with KRAS G12C-mutated, unresectable, advanced and/or recurrent non-small-cell lung cancer, that has progressed after systemic anticancer therapy in Japan (20210051)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47965
• EU PAS number:
  EUPAS46655
• Study ID:
  47965
• Official title and acronym:
  Special Drug Use-Results Surveillance (all-case) for sotorasib in patients with KRAS G12C-mutated, unresectable, advanced and/or recurrent non-small-cell lung cancer, that has progressed after systemic anticancer therapy in Japan (20210051)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 20/04/2022

Actual: 20/04/2022

Study start date

Planned: 01/07/2022

Actual: 30/06/2022

Data analysis start date

Planned: 01/08/2026

Date of final study report

Planned: 01/08/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original sotorasib 20210051 .pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only