Nivolumab plus ipilimumab plus chemo vs pembrolizumab plus chemo in PD-L1 negative metastatic NSCLC patients: comparative effectiveness using the target trial emulation framework.

Study identification

• EU PAS number:
  EUPAS1000001143
• Study ID:
  1000001143
• Official title and acronym:
  Nivolumab plus ipilimumab plus chemo vs pembrolizumab plus chemo in PD-L1 negative metastatic NSCLC patients: comparative effectiveness using the target trial emulation framework.
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This retrospective new user active comparator cohort study adapting the target trial emulation frameowrk enables the head-to-head comparison of nivolumab plus ipilimumab plus platinum doublet chemotherapy (CheckMate 9LA)with pembrolizumab plus platinum doublet chemotherapy (KEYNOTE-189 and KEYNOTE-407) in adults with metastatic stage IV NSCLC; using data from the Dutch Medication Audit (DMA) and the Dutch Lung Cancer Audit - lungcarcinoma (DLCA-L) from the Dutch Institute for Clinical Auditing (DICA). ; ; At the time of writing the protocol, the authors became aware of the planned study EUPAS1000000987, part of the TARGET-EU project. However, this study protocol has been designed and will be executed independently from the TARGET-EU team, and will make use of a different observational data source. As a result, this study provides additional knowledge on the head-to-head effectiveness on top of the original KEYNOTE and CheckMate trials and the TARGET-EU study, and provide knowledge on how to design and execute trial emulations of randomized controlled trials for lung cancer using the estimand framework (to allow for independent comparison with the TARGET-EU study). ; ; Moreover, as secondary analyses in this study, cost-effectiveness will be assessed for both therapies (Track A) and different estimands for the effectiveness will be studied to see their methodological implications (Track B).
• Study status:
  Planned

Research institutions and networks

Institutions

University of Groningen

Netherlands

University Medical Center Groningen

Dutch Institute for Clinical Auditing, Medicines Evaluation Board.

Study timelines

Date when funding contract was signed

Planned:02/03/2026

Study start date

Planned:01/09/2026

Data analysis start date

Planned:01/11/2026

Date of interim report, if expected

Planned:31/12/2026

Date of final study report

Planned:01/02/2027

Sources of funding

EU institutional research programme

More details on funding

This study is funded by the European Union’s Horizon Europe Research and Innovation Actions under grant no. 101095479 (More-EUROPA). Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union nor the granting authority. Neither the European Union nor the granting authority can be held responsible for them.

Regulatory

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