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Investigator-Initiated Studies Main Article

Investigator-Initiated Studies

Daiichi Sankyo is committed to supporting research to address unmet medical needs of patients around the world.

Daiichi Sankyo offers the opportunity for external researchers who are interested in conducting their own research related to Daiichi Sankyo therapeutic areas of interest to submit an independent research concept that is subsequently reviewed by an internal review committee. Daiichi Sankyo may provide funding and other forms of support, such as clinical trial material, to support studies initiated and sponsored by external researchers.

If you would like to read about our current therapeutic areas of focus click Product Pipeline. If you are interested in submitting a concept, or have a question, please review  the Investigator-Initiated Study (IIS) Reference Guide and submit your concept to https://daiichisankyo-iis.com/.

When you are ready, please submit your concept to:

If you are interested in submitting a concept related to trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki in the United States only), please review the Areas of Interest prior to making your submission.

Please note for all submissions:

  •  Concepts will be prioritized accordingly based on scientific merit and fit with the clinical program.
     
HER2+ mBC
  • Data to enable adverse event management guidelines and improvement in adherence to treatment
  • Data on efficacy and safety in special populations not adequately represented in DESTINY clinical trials
  • Real world data on standard of care across geographies and lines of treatment
HER2 Low mBC
  • Optimization of practice parameters that enhance reliability and accuracy of identification of patients with HER2 low mBC
  • Real world efficacy, adverse event, and patient reported outcome in mBC, including special populations not adequately represented in DESTINY clinical trials
  • Biomarker studies, including circulating tumor (ct) DNA, to explore mechanisms of resistant to standard of care therapy and/or T-DXd, as well as identify patients with high response to T-DXd
HER2+ mGC
  • Patient selection and outcomes with liquid biopsy and concordance with tissue biopsy
  • Data on optimal sequencing and maintenance therapy
  • Clinical activity and safety in additional populations (e.g., performance status 2, peritoneal only disease, esophageal adenocarcinoma)
HER2 Targetable NSCLC
  • Interstitial lung disease management/mechanism in lung cancer and optimization of adverse event management
  • Efficacy/safety in special patient population with HER2 mutated NSCLC (eg: Brain mets)
  • Approaches and validated technologies to inform more efficient patient selection in HER2 mutated NSCLC