RAStik: A Retrospective Cohort Analysis of Survival and Treatment Outcomes of Docetaxel in KRAS G12C Mutated Locally Advanced or Metastatic NSCLC (20190411)

Study identification

• EU PAS number:
  EUPAS38357
• Study ID:
  49082
• Official title and acronym:
  RAStik: A Retrospective Cohort Analysis of Survival and Treatment Outcomes of Docetaxel in KRAS G12C Mutated Locally Advanced or Metastatic NSCLC (20190411)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This is a retrospective, observational cohort study of KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) patients. Patients are identified from Network Genomic Medicine (NGM) Network Database. The study period is from 01 July 2015 through to 31 December 2019. Approximately 150 patients will be randomly selected from the NGM (Network Genomic Medicine) database. The patients will be over the age of 18 with a pathologically documented locally advanced or metastatic NSCLC, who have a record of treatment with docetaxel (monotherapy or combination) in ≥second-line. The primary objectives of the study are to evaluate the real-world effectiveness of docetaxel (monotherapy or combination) and estimate overall and progression-free survival.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 300 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:25/06/2020

Actual:25/06/2020

Study start date

Planned:31/10/2020

Actual:31/10/2020

Data analysis start date

Planned:01/03/2021

Actual:23/05/2022

Date of final study report

Planned:31/07/2023

Actual:25/07/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

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