Study identification

PURI

https://redirect.ema.europa.eu/resource/49082

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
First published:
21/02/2024
Institution
Multiple centres: 300 centres are involved in the study

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 final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol

Protocol-Published Original Sotorasib 20190411

English (649.17 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable