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NCT04165798Recruiting

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)

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)

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1065 (estimated)
First submitted
13 Nov 2019
Start date
19 Dec 2019
Primary completion date
13 Feb 2032
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
Lung cancer
NCT number
NCT04165798

What you commit to

  • Study type: Observational
  • Planned participants: 1065
  • From 19 Dec 2019 to the primary completion date, 13 Feb 2032
  • 48 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • The main exclusion criteria include but are not limited to the following:

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (48)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cross Cancer Institute ( Site 0291)
Coordinator of this site? Confirm its status
EdmontonCanadaRecruiting
Hospital Clinic de Barcelona ( Site 0092)
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
ICO L Hospitalet ( Site 0090)
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario Quiron Madrid ( Site 0091)
Coordinator of this site? Confirm its status
MadridSpainCompleted
Országos Korányi Pulmonológiai Intézet ( Site 0060)
Coordinator of this site? Confirm its status
BudapestHungaryCompleted
Petz Aladar Megyei Oktato Korhaz ( Site 0062)
Coordinator of this site? Confirm its status
GyőrHungaryCompleted
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)
Coordinator of this site? Confirm its status
SzolnokHungaryCompleted
Soroka Medical Center ( Site 0072)
Coordinator of this site? Confirm its status
BeershebaIsraelCompleted
Rambam Health Care Campus-Oncology ( Site 0076)
Coordinator of this site? Confirm its status
HaifaIsraelCompleted
Shaare Zedek Medical Center ( Site 0075)
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
Meir Medical Center ( Site 0071)
Coordinator of this site? Confirm its status
Kfar SabaIsraelCompleted
Rabin Medical Center ( Site 0074)
Coordinator of this site? Confirm its status
Petah TikvaIsraelCompleted
Chaim Sheba Medical Center ( Site 0070)
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
Sourasky Medical Center ( Site 0077)
Coordinator of this site? Confirm its status
Tel AvivIsraelCompleted
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Coordinator of this site? Confirm its status
FlorenceItalyCompleted
IRCCS Ospedale San Raffaele ( Site 0171)
Coordinator of this site? Confirm its status
MilanItalyCompleted
Policlinico Gemelli di Roma ( Site 0174)
Coordinator of this site? Confirm its status
RomaItalyCompleted
Seoul National University Bundang Hospital ( Site 0081)
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaCompleted
Severance Hospital ( Site 0080)
Coordinator of this site? Confirm its status
SeoulSouth KoreaCompleted
Samsung Medical Center ( Site 0082)
Coordinator of this site? Confirm its status
SeoulSouth KoreaCompleted
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Coordinator of this site? Confirm its status
GdanskPolandCompleted
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)
Coordinator of this site? Confirm its status
KoszalinPolandActive, not recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Changhua Christian Hospital ( Site 0181)
Coordinator of this site? Confirm its status
ChanghuaTaiwanRecruiting
Taipei Medical University Hospital ( Site 0180)
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Chang Gung Medical Foundation-Linkou Branch ( Site 0182)
Coordinator of this site? Confirm its status
TaoyuanTaiwanRecruiting
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)
Coordinator of this site? Confirm its status
CherkasyUkraineRecruiting
Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 0460)
Coordinator of this site? Confirm its status
Ivano-FrankivskUkraineRecruiting
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)
Coordinator of this site? Confirm its status
RivneUkraineRecruiting
Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)
Coordinator of this site? Confirm its status
UzhhorodUkraineRecruiting
MedStar Franklin Square Medical Center ( Site 0033)
Coordinator of this site? Confirm its status
BaltimoreUnited StatesCompleted
Massachusetts General Hospital ( Site 0003)
Coordinator of this site? Confirm its status
BostonUnited StatesCompleted
Dana Farber Cancer Institute ( Site 0002)
Coordinator of this site? Confirm its status
BostonUnited StatesCompleted
Cleveland Clinic Main ( Site 0006)
Coordinator of this site? Confirm its status
ClevelandUnited StatesCompleted
Ohio State University Comprehensive Cancer Center ( Site 0015)
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
City of Hope ( Site 0014)
Coordinator of this site? Confirm its status
DuarteUnited StatesCompleted
Sanford Fargo Medical Center ( Site 0039)
Coordinator of this site? Confirm its status
FargoUnited StatesRecruiting
Banner MD Anderson Cancer Center ( Site 0001)
Coordinator of this site? Confirm its status
GilbertUnited StatesCompleted
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)
Coordinator of this site? Confirm its status
HackensackUnited StatesCompleted
The University of Texas MD Anderson Cancer Center ( Site 0009)
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Dartmouth Hitchcock Medical Center ( Site 0016)
Coordinator of this site? Confirm its status
LebanonUnited StatesRecruiting
University of Kentucky Markey Cancer Center ( Site 0019)
Coordinator of this site? Confirm its status
LexingtonUnited StatesCompleted
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)
Coordinator of this site? Confirm its status
New YorkUnited StatesCompleted
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)
Coordinator of this site? Confirm its status
OmahaUnited StatesCompleted
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
UCSF Medical Center at Mission Bay ( Site 0007)
Coordinator of this site? Confirm its status
San FranciscoUnited StatesCompleted
Sanford Cancer Center ( Site 0038)
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesRecruiting
Georgetown University ( Site 0036)
Coordinator of this site? Confirm its status
Washington D.C.United StatesCompleted

This page is information, not medical advice. Discuss any trial with your doctor.