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Be Part of Research - Trial Details - DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
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DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

London London Manchester Sutton

Medical Conditions

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2020 Jul 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab.

Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin. All participants will receive DS-8201a at the RDE in combination with pembrolizumab.

Intervention Arm Group : HER2-expressing NSCLC (Part 2 Dose Expansion);HER2-low breast cancer (Part 2 Dose Expansion);HER2-mutant NSCLC (Part 2 Dose Expansion);HER2-positive breast cancer (Part 2 Dose Expansion);

Intervention Type : DRUG
Intervention Description : Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab.

Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin.

Intervention Arm Group : Part 1 (Dose Escalation);

Intervention Type : DRUG
Intervention Description : All participants will receive pembrolizumab (200 mg Q3W) via intravenous (IV) infusion prior to DS-8201a in Parts 1 and 2 of the study.

Intervention Arm Group : HER2-expressing NSCLC (Part 2 Dose Expansion);HER2-low breast cancer (Part 2 Dose Expansion);HER2-mutant NSCLC (Part 2 Dose Expansion);HER2-positive breast cancer (Part 2 Dose Expansion);Part 1 (Dose Escalation);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden NHS Foundation Trust
    London
    SW3 6JJ
  • Sarah Cannon Research Institute (SCRI)
    London
    W1G 6AD
  • The Christie NHS Fond. Trust
    Manchester
    M20 4BX
  • Royal Marsden Hosptial
    Sutton
    SM2 5PT


The study is sponsored by Daiichi Sankyo and is in collaboration with AstraZeneca UK Limited; Merck Sharp & Dohme LLC.



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Read full details for Trial ID: NCT04042701
Last updated 21 February 2025

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