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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)

NCT ID: NCT04165798

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1065 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-19

Study Completion Date

2032-02-13

Brief Summary

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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.

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KEYMAKER-U01 Substudy 2: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Treatment-naïve Participants With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B/KEYMAKER-U01B)

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KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

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KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C)

NCT04165096

Carcinoma, Non-Small-Cell Lung
COMPLETED PHASE2

Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)

NCT06788912

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RECRUITING PHASE2

A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)

NCT06731907

Non-small Cell Lung Cancer
RECRUITING PHASE2

Detailed Description

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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) - NCT number pending
* 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) - NCT number pending

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective NSCLC Participants

Male and female participants with histologically-confirmed diagnosis of squamous or nonsquamous NSCLC will be screened for participation in 1 of several pembrolizumab substudies.

Tumor Imaging

Intervention Type DIAGNOSTIC_TEST

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

Tumor Tissue Collection

Intervention Type PROCEDURE

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

Blood Sample Collection

Intervention Type PROCEDURE

Participants will have blood samples drawn for analysis of:

* genetics
* ribonucleic acid (RNA)
* serum biomarker
* plasma biomarker
* circulating tumor DNA (ctDNA)

Interventions

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Tumor Imaging

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

Intervention Type DIAGNOSTIC_TEST

Tumor Tissue Collection

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

Intervention Type PROCEDURE

Blood Sample Collection

Participants will have blood samples drawn for analysis of:

* genetics
* ribonucleic acid (RNA)
* serum biomarker
* plasma biomarker
* circulating tumor DNA (ctDNA)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Banner MD Anderson Cancer Center ( Site 0001)

Gilbert, Arizona, United States

Site Status RECRUITING

City of Hope ( Site 0014)

Duarte, California, United States

Site Status COMPLETED

UCSF Medical Center at Mission Bay ( Site 0007)

San Francisco, California, United States

Site Status COMPLETED

Georgetown University ( Site 0036)

Washington D.C., District of Columbia, United States

Site Status COMPLETED

University of Kentucky Markey Cancer Center ( Site 0019)

Lexington, Kentucky, United States

Site Status RECRUITING

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

Massachusetts General Hospital ( Site 0003)

Boston, Massachusetts, United States

Site Status RECRUITING

Dana Farber Cancer Institute ( Site 0002)

Boston, Massachusetts, United States

Site Status RECRUITING

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

Omaha, Nebraska, United States

Site Status RECRUITING

Dartmouth Hitchcock Medical Center ( Site 0016)

Lebanon, New Hampshire, United States

Site Status RECRUITING

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

Hackensack, New Jersey, United States

Site Status COMPLETED

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

New York, New York, United States

Site Status RECRUITING

Sanford Fargo Medical Center ( Site 0039)

Fargo, North Dakota, United States

Site Status RECRUITING

Cleveland Clinic Main ( Site 0006)

Cleveland, Ohio, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center ( Site 0015)

Columbus, Ohio, United States

Site Status RECRUITING

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

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Sanford Cancer Center ( Site 0038)

Sioux Falls, South Dakota, United States

Site Status RECRUITING

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

Houston, Texas, United States

Site Status RECRUITING

Petz Aladar Megyei Oktato Korhaz ( Site 0062)

Győr, Győr-Moson-Sopron, Hungary

Site Status RECRUITING

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

Szolnok, Jász-Nagykun-Szolnok, Hungary

Site Status RECRUITING

Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)

Budapest, , Hungary

Site Status RECRUITING

Soroka Medical Center ( Site 0072)

Beersheba, , Israel

Site Status COMPLETED

Rambam Health Care Campus-Oncology ( Site 0076)

Haifa, , Israel

Site Status ACTIVE_NOT_RECRUITING

Shaare Zedek Medical Center ( Site 0075)

Jerusalem, , Israel

Site Status RECRUITING

Meir Medical Center ( Site 0071)

Kfar Saba, , Israel

Site Status ACTIVE_NOT_RECRUITING

Rabin Medical Center ( Site 0074)

Petah Tikva, , Israel

Site Status ACTIVE_NOT_RECRUITING

Chaim Sheba Medical Center ( Site 0070)

Ramat Gan, , Israel

Site Status RECRUITING

Sourasky Medical Center ( Site 0077)

Tel Aviv, , Israel

Site Status ACTIVE_NOT_RECRUITING

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, Firenze, Italy

Site Status COMPLETED

IRCCS Ospedale San Raffaele ( Site 0171)

Milan, , Italy

Site Status COMPLETED

Policlinico Gemelli di Roma ( Site 0174)

Roma, , Italy

Site Status RECRUITING

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

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

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

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

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

Koszalin, West Pomeranian Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Seoul National University Bundang Hospital ( Site 0081)

Seongnam-si, Kyonggi-do, South Korea

Site Status RECRUITING

Severance Hospital ( Site 0080)

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center ( Site 0082)

Seoul, , South Korea

Site Status RECRUITING

ICO L Hospitalet ( Site 0090)

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Hospital Clínic de Barcelona ( Site 0092)

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Quiron Madrid ( Site 0091)

Madrid, , Spain

Site Status RECRUITING

Countries

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United States Hungary Israel Italy Poland South Korea Spain

Central Contacts

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Toll Free Number

Role: CONTACT

[email protected]
1-888-577-8839

Facility Contacts

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Study Coordinator

Role: primary

480-256-3425

Study Coordinator

Role: primary

859-218-0131

Study Coordinator

Role: primary

617-724-4000

Study Coordinator

Role: primary

617-632-4767

Study Coordinator

Role: primary

402-691-6971

Study Coordinator

Role: primary

603-650-4428

Study Coordinator

Role: primary

929-455-2428

Study Coordinator

Role: primary

701-234-2000

Study Coordinator

Role: primary

216-636-6888

Study Coordinator

Role: primary

614-366-0233

Study Coordinator

Role: primary

215-220-9703

Study Coordinator

Role: primary

605-328-8000

Study Coordinator

Role: primary

713-792-6363

Study Coordinator

Role: primary

+3696418244

Study Coordinator

Role: primary

+36209323256

Study Coordinator

Role: primary

+3613913364

Study Coordinator

Role: primary

+972587040620

Study Coordinator

Role: primary

+97235307096

Study Coordinator

Role: primary

+390630155202

Study Coordinator

Role: primary

+48225463066

Study Coordinator

Role: primary

+48 58 584 44 66

Study Coordinator

Role: primary

+82215883369

Study Coordinator

Role: primary

+82222280880

Study Coordinator

Role: primary

+82215993114

Study Coordinator

Role: primary

0034932607744

Study Coordinator

Role: primary

34 932275402

Study Coordinator

Role: primary

+34914521987

Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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MK-3475-U01

Identifier Type: OTHER

Identifier Source: secondary_id

KEYMAKER-U01

Identifier Type: OTHER

Identifier Source: secondary_id

3475-U01

Identifier Type: -

Identifier Source: org_study_id

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