A multi-center prospective non-interventional study to understand the use of next generation sequencing (NGS) in patients with metastatic non-small cell lung cancer and metastatic colorectal cancer in Belgium.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107703
• EU PAS number:
  EUPAS107702
• Study ID:
  107703
• Official title and acronym:
  A multi-center prospective non-interventional study to understand the use of next generation sequencing (NGS) in patients with metastatic non-small cell lung cancer and metastatic colorectal cancer in Belgium.
• DARWIN EU® study:
  No
• Study countries:
  Belgium
• Study description:
  There is a lack of real-world data relating to how next generation sequencing (NGS) is being implemented and adopted in real-world clinical practice and associated clinical outcomes. Belgium has recently implemented a national policy to make NGS use available to all cancer patients, thus representing an ideal population to examine the use of NGS in standard clinical practice and associated treatment patterns and outcomes. The primary objectives of this study are to describe the real-world time from diagnosis of metastatic colorectal cancer (mCRC) or metastatic non-small cell lung cancer (mNSCLC) to NGS test result and the real-world time from NGS test result to treatment in the overall cohort and across selected patient, clinical, disease, treatment and healthcare resource utilization (HCRU) characteristics for patients who undergo NGS testing within routine clinical practice in Belgium and the HRUC and overall survival of patients. The secondary objectives of this study are to describe the current practices for implementing NGS testing in clinical settings, the baseline characteristics, and clinical and disease characteristics in patients with mNSCLC or mCRC who undergo NGS testing within routine clinical practice in Belgium.
• Study status:
  Planned

Research institution and networks

Institutions

Merck & Co.

OPEN Health

Study timelines

Date when funding contract was signed

Actual: 02/06/2022

Study start date

Planned: 26/02/2024

Data analysis start date

Planned: 31/12/2024

Date of final study report

Planned: 31/03/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp &amp, Dohme LLC

Regulatory

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