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Carcinoma, Non-Small-Cell LungNCT04165798

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)

An observational study of Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 48 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Tumor Imaging, Tumor Tissue Collection and Blood Sample Collection
Type of treatment
Surgery or procedure
How many people
1,065 participants
Where
48 sitesin 10 countries
Study dates
19 Dec 2019to 13 Feb 2032
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Male and female participants with histologically-confirmed diagnosis of squamous or nonsquamous NSCLC

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

48 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

48 sites in 10 countries

United States18 sites, 6 recruiting

  • MedStar Franklin Square Medical Center ( Site 0033)

    Baltimore, Maryland, 21237

    Completed

  • Massachusetts General Hospital ( Site 0003)

    Boston, Massachusetts, 02114

    Completed

  • Dana Farber Cancer Institute ( Site 0002)

    Boston, Massachusetts, 02215

    Completed

  • Cleveland Clinic Main ( Site 0006)

    Cleveland, Ohio, 44195

    Completed

  • Ohio State University Comprehensive Cancer Center ( Site 0015)

    Columbus, Ohio, 43210

    Study Coordinator, 614-366-0233

    Recruiting

  • City of Hope ( Site 0014)

    Duarte, California, 91010

    Completed

  • Sanford Fargo Medical Center ( Site 0039)

    Fargo, North Dakota, 58102

    Study Coordinator, 701-234-2000

    Recruiting

  • Banner MD Anderson Cancer Center ( Site 0001)

    Gilbert, Arizona, 85234

    Completed

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)

    Hackensack, New Jersey, 07601

    Completed

  • The University of Texas MD Anderson Cancer Center ( Site 0009)

    Houston, Texas, 77030

    Study Coordinator, 713-792-6363

    Recruiting

  • Dartmouth Hitchcock Medical Center ( Site 0016)

    Lebanon, New Hampshire, 03766

    Study Coordinator, 603-650-4428

    Recruiting

  • University of Kentucky Markey Cancer Center ( Site 0019)

    Lexington, Kentucky, 40536-0293

    Completed

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)

    New York, New York, 10016

    Completed

  • Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)

    Omaha, Nebraska, 68130

    Completed

  • Abramson Cancer Center of the University of Pennsylvania ( Site 0010)

    Philadelphia, Pennsylvania, 19104

    Study Coordinator, 215-220-9703

    Recruiting

  • UCSF Medical Center at Mission Bay ( Site 0007)

    San Francisco, California, 94158

    Completed

  • Sanford Cancer Center ( Site 0038)

    Sioux Falls, South Dakota, 57104

    Study Coordinator, 605-328-8000

    Recruiting

  • Georgetown University ( Site 0036)

    Washington D.C., District of Columbia, 20007

    Completed

Other trials in United States

Israel7 sites, 2 recruiting

  • Soroka Medical Center ( Site 0072)

    Beersheba, 8457108

    Completed

  • Rambam Health Care Campus-Oncology ( Site 0076)

    Haifa, 3109601

    Completed

  • Shaare Zedek Medical Center ( Site 0075)

    Jerusalem, 9103102

    Study Coordinator, +972587040620

    Recruiting

  • Meir Medical Center ( Site 0071)

    Kfar Saba, 4428132

    Completed

  • Rabin Medical Center ( Site 0074)

    Petah Tikva, 4941492

    Completed

  • Chaim Sheba Medical Center ( Site 0070)

    Ramat Gan, 5262000

    Study Coordinator, +97235307096

    Recruiting

  • Sourasky Medical Center ( Site 0077)

    Tel Aviv, 6423906

    Completed

Other trials in Israel

Ukraine4 sites, 4 recruiting

  • COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)

    Cherkasy, Cherkasy Oblast, 18009

    Study Coordinator, +380472370123

    Recruiting

  • Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 0460)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Study Coordinator, +380978411455

    Recruiting

  • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)

    Rivne, Rivne Oblast, 33010

    Study Coordinator, +380362633075

    Recruiting

  • Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)

    Uzhhorod, Zakarpattia Oblast, 88017

    Study Coordinator, +380506847086

    Recruiting

Other trials in Ukraine

Hungary3 sites

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)

    Budapest, 1121

    Completed

  • Petz Aladar Megyei Oktato Korhaz ( Site 0062)

    Győr, Győr-Moson-Sopron, 9024

    Completed

  • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)

    Szolnok, Jász-Nagykun-Szolnok, 5004

    Completed

Other trials in Hungary

Italy3 sites

  • Azienda Ospedaliera Universitaria Careggi ( Site 0173)

    Florence, Firenze, 50134

    Completed

  • IRCCS Ospedale San Raffaele ( Site 0171)

    Milan, 20132

    Completed

  • Policlinico Gemelli di Roma ( Site 0174)

    Roma, 00168

    Completed

Other trials in Italy

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

    Gdansk, Pomeranian Voivodeship, 80-952

    Completed

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)

    Koszalin, West Pomeranian Voivodeship, 75-581

    Active, not recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)

    Warsaw, Masovian Voivodeship, 02-781

    Completed

Other trials in Poland

South Korea3 sites

  • Seoul National University Bundang Hospital ( Site 0081)

    Seongnam-si, Kyonggi-do, 13620

    Completed

  • Severance Hospital ( Site 0080)

    Seoul, 03722

    Completed

  • Samsung Medical Center ( Site 0082)

    Seoul, 06351

    Completed

Other trials in South Korea

Spain3 sites, 1 recruiting

  • Hospital Clinic de Barcelona ( Site 0092)

    Barcelona, 08008

    Study Coordinator, 34 932275402

    Recruiting

  • ICO L Hospitalet ( Site 0090)

    L'Hospitalet de Llobregat, Barcelona, 08907

    Completed

  • Hospital Universitario Quiron Madrid ( Site 0091)

    Madrid, 28223

    Completed

Other trials in Spain

Taiwan3 sites, 3 recruiting

  • Changhua Christian Hospital ( Site 0181)

    Changhua, 50006

    Study Coordinator, +88647238595

    Recruiting

  • Taipei Medical University Hospital ( Site 0180)

    Taipei, 110301

    Study Coordinator, +886227372181x7810

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch ( Site 0182)

    Taoyuan, 33305

    Study Coordinator, +886975368109

    Recruiting

Other trials in Taiwan

Canada1 site, 1 recruiting

  • Cross Cancer Institute ( Site 0291)

    Edmonton, Alberta, T6G 1Z2

    Study Coordinator, 780-432-8771

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the detailed description

The following pembrolizumab substudies will evaluate the efficacy of different investigational agents in combination with pembrolizumab given in sequence or in combination with pembrolizumab PLUS chemotherapy:

  • KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A) - NCT04165070
  • KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Treatment Naïve Patients with PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B) - NCT04165083
  • KEYMAKER-U01 Substudy 3: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated with anti-PD-(L)1 Therapy (MK-3475-01C) - NCT04165096
  • KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E) - NCT06788912
  • KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Second-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations (MK-3475-01F) - NCT07286149
  • KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01G) - NCT06731907
  • KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants with Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H) - NCT06780085
  • KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I) - NCT06780098
  • KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations (MK-3475-01J) - NCT07252739
Being tested
Tumor Imaging, Tumor Tissue Collection, Blood Sample Collection
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tumor ImagingDiagnostic test

    Participants will undergo tumor imaging using either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.

  • Tumor Tissue CollectionProcedure or surgery

    Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue.

  • Blood Sample CollectionProcedure or surgery

    Participants will have blood samples drawn for analysis of:

    • genetics
    • ribonucleic acid (RNA)
    • serum biomarker
    • plasma biomarker
    • circulating tumor DNA (ctDNA)
Study groups in NCT04165798
Study groupRoleWhat they receive
Prospective NSCLC ParticipantsMale and female participants with histologically-confirmed diagnosis of squamous or nonsquamous NSCLC will be screened for participation in 1 of several pembrolizumab substudies.
Receives: Diagnostic Test: Tumor Imaging; Procedure: Tumor Tissue Collection; Procedure: Blood Sample Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1%

    Participants' tumors will be evaluated for their PD-L1 tumor expression level using archival tumor tissue samples or newly obtained tumor tissue. The percentage of participants who have a Tumor Proportion Score (TPS) <1% vs. a TPS =1% will be presented.

    Measured: Up to approximately 1 month

  2. Tumor Histology Status: Squamous Non-small Cell Lung Cancer (NSCLC) vs. Nonsquamous NSCLC

    Participants' tumors will be evaluated for their tumor histology status as being either squamous vs. nonsquamous NSCLC using archival or newly obtained tumor tissue samples. The percentage of participants who have squamous vs. nonsquamous NSCLC will be presented.

    Measured: Up to approximately 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2019
  2. Study start19 Dec 2019
  3. Primary completion13 Feb 2032 (estimated)
  4. Study completion13 Feb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,065 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04165798
Sponsor's protocol ID
3475-U01
Other IDs
MK-3475-U01, KEYMAKER-U01
Status last verified
Oct 2026
First submitted
13 Nov 2019
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 48 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Israel, Ukraine, Hungary, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1% (time frame: Up to approximately 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04165798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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