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
- Changhua, Taipei, and Taoyuan, TaiwanSee the 3 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage IV non-small cell lung cancer (squamous or nonsquamous) who have measurable disease.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Stage IV squamous or nonsquamous non-small cell lung cancer (NSCLC), confirmed by tissue or cell tests, with measurable disease per RECIST version 1.1
Main reasons for not taking part
- Active autoimmune disease that needed systemic treatment in the past 2 years
- History of pneumonitis or interstitial lung disease that needed steroids, or current pneumonitis or interstitial lung disease
- Active infection that needs systemic therapy
Read by machine on 12 November 2026.
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 Taiwan
- Changhua Christian Hospital (Site 0181)Changhua, TaiwanContact: Study CoordinatorTaking people
- Taipei Medical University Hospital (Site 0180)Taipei, TaiwanContact: Study CoordinatorTaking people
- Chang Gung Medical Foundation-Linkou Branch (Site 0182)Taoyuan, TaiwanContact: Study CoordinatorTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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:.