Screens lung cancer patients for studies of new drugs with pembrolizumab
Screens adults with non-small cell lung cancer for later drug studies using pembrolizumab.
Plain-language title generated from the registry record
Registry title: KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
Key facts
- Where
- Edmonton, CanadaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT04165798, who can take part
Where in Canada
- Cross Cancer Institute (Site 0291)Edmonton, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT04165798
- Record updated
- 29 October 2026
- Original description
This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.Read full original descriptionShow less
KEYMAKER-U01 Master Study: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants With Non-small Cell Lung Cancer (NSCLC)
This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.
Inclusion: The main inclusion criteria include but are not limited to the following:; Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC; Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1.
Exclusion: Has an active autoimmune disease that has required systemic treatment in the past 2 years; Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; Has an active infection requiring systemic therapy; The main exclusion criteria include but are not limited to the following:.