Actively Recruiting
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)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-17
1065
Participants Needed
47
Research Sites
634 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC
- Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1
You will not qualify if you...
- Active autoimmune disease requiring systemic treatment in the past 2 years
- History of pneumonitis or interstitial lung disease that needed steroids or current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
Banner MD Anderson Cancer Center ( Site 0001)
Gilbert, Arizona, United States, 85234
Completed
2
City of Hope ( Site 0014)
Duarte, California, United States, 91010
Completed
3
UCSF Medical Center at Mission Bay ( Site 0007)
San Francisco, California, United States, 94158
Completed
4
Georgetown University ( Site 0036)
Washington D.C., District of Columbia, United States, 20007
Completed
5
University of Kentucky Markey Cancer Center ( Site 0019)
Lexington, Kentucky, United States, 40536-0293
Completed
6
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, United States, 21237
Completed
7
Massachusetts General Hospital ( Site 0003)
Boston, Massachusetts, United States, 02114
Completed
8
Dana Farber Cancer Institute ( Site 0002)
Boston, Massachusetts, United States, 02215
Completed
9
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)
Omaha, Nebraska, United States, 68130
Completed
10
Dartmouth Hitchcock Medical Center ( Site 0016)
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
11
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)
Hackensack, New Jersey, United States, 07601
Completed
12
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)
New York, New York, United States, 10016
Completed
13
Sanford Fargo Medical Center ( Site 0039)
Fargo, North Dakota, United States, 58102
Actively Recruiting
14
Cleveland Clinic Main ( Site 0006)
Cleveland, Ohio, United States, 44195
Completed
15
Ohio State University Comprehensive Cancer Center ( Site 0015)
Columbus, Ohio, United States, 43210
Actively Recruiting
16
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
17
Sanford Cancer Center ( Site 0038)
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
18
The University of Texas MD Anderson Cancer Center ( Site 0009)
Houston, Texas, United States, 77030
Actively Recruiting
19
Petz Aladar Megyei Oktato Korhaz ( Site 0062)
Győr, Győr-Moson-Sopron, Hungary, 9024
Completed
20
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok, Hungary, 5004
Completed
21
Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)
Budapest, Hungary, 1121
Completed
22
Soroka Medical Center ( Site 0072)
Beersheba, Israel, 8457108
Completed
23
Rambam Health Care Campus-Oncology ( Site 0076)
Haifa, Israel, 3109601
Completed
24
Shaare Zedek Medical Center ( Site 0075)
Jerusalem, Israel, 9103102
Actively Recruiting
25
Meir Medical Center ( Site 0071)
Kfar Saba, Israel, 4428132
Completed
26
Rabin Medical Center ( Site 0074)
Petah Tikva, Israel, 4941492
Completed
27
Chaim Sheba Medical Center ( Site 0070)
Ramat Gan, Israel, 5262000
Actively Recruiting
28
Sourasky Medical Center ( Site 0077)
Tel Aviv, Israel, 6423906
Completed
29
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Firenze, Italy, 50134
Completed
30
IRCCS Ospedale San Raffaele ( Site 0171)
Milan, Italy, 20132
Completed
31
Policlinico Gemelli di Roma ( Site 0174)
Roma, Italy, 00168
Completed
32
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
33
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Completed
34
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)
Koszalin, West Pomeranian Voivodeship, Poland, 75-581
Active, Not Recruiting
35
Seoul National University Bundang Hospital ( Site 0081)
Seongnam-si, Kyonggi-do, South Korea, 13620
Completed
36
Severance Hospital ( Site 0080)
Seoul, South Korea, 03722
Completed
37
Samsung Medical Center ( Site 0082)
Seoul, South Korea, 06351
Completed
38
ICO L Hospitalet ( Site 0090)
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
39
Hospital Clínic de Barcelona ( Site 0092)
Barcelona, Spain, 08008
Actively Recruiting
40
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, Spain, 28223
Actively Recruiting
41
Changhua Christian Hospital ( Site 0181)
Changhua, Taiwan, 50006
Actively Recruiting
42
Taipei Medical University Hospital ( Site 0180)
Taipei, Taiwan, 110301
Actively Recruiting
43
Chang Gung Medical Foundation-Linkou Branch ( Site 0182)
Taoyuan, Taiwan, 33305
Actively Recruiting
44
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)
Cherkasy, Cherkasy Oblast, Ukraine, 18009
Actively Recruiting
45
Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 0460)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
Actively Recruiting
46
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)
Rivne, Rivne Oblast, Ukraine, 33010
Actively Recruiting
47
Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)
Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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