DARWIN EU® Overall survival in patients with locally advanced or metastatic non-small cell lung cancer treated with selected immunotherapies as first line of treatment

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000112
• EU PAS number:
  EUPAS1000000112
• Study ID:
  1000000112
• Official title and acronym:
  DARWIN EU® Overall survival in patients with locally advanced or metastatic non-small cell lung cancer treated with selected immunotherapies as first line of treatment
• DARWIN EU® study:
  Yes
• Study countries:
  France

  Netherlands

  Spain
• Study description:
  Comparative Effectiveness Study
• Study status:
  Ongoing

Research institution and networks

Institutions

Department of Medical Informatics - Health Data Science, Erasmus Medical Center (ErasmusMC)

Netherlands

Real-World-Evidence, IQVIA NL

Netherlands

Parc de Salut Mar Barcelona (PSMAR)

Spain

Networks

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Belgium

Croatia

Denmark

Estonia

Finland

France

Germany

Hungary

Netherlands

Norway

Portugal

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 26/06/2023

Actual: 26/06/2023

Study start date

Planned: 29/02/2024

Actual: 26/03/2024

Date of interim report, if expected

Planned: 28/06/2024

Date of final study report

Planned: 07/03/2025

Sources of funding

EMA

Study protocol

Initial protocol

DARWIN EU_D2.2.3_Protocol_P2-C3-003_NSCLC_v3.2_Clean.pdf

Updated protocol

DARWIN EU_Protocol_P2-C3-003_NSCLC_V5_Amendment.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable