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)

NCT04165798 · tracked via the Priya Life Science Taiwan tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Observational

Started

2019-12-19

Last updated

2026-08-25

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

Tumor ImagingTumor Tissue CollectionBlood Sample Collection

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

Tumor Tissue Collection: Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue.

Blood Sample Collection: Participants will have blood samples drawn for analysis of: * genetics * ribonucleic acid (RNA) * serum biomarker * plasma biomarker * circulating tumor DNA (ctDNA)

Study 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. Each substudy will enroll a different population of NSCLC participants.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Primary outcome measure(s)

Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1% — Up to approximately 1 month
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.
Tumor Histology Status: Squamous Non-small Cell Lung Cancer (NSCLC) vs. Nonsquamous NSCLC — Up to approximately 1 month
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.

Trial sites (47)

Facility	City	Region	Status
Banner MD Anderson Cancer Center ( Site 0001)	Gilbert	Arizona	Active Not Recruiting
City of Hope ( Site 0014)	Duarte	California	Completed
UCSF Medical Center at Mission Bay ( Site 0007)	San Francisco	California	Completed
Georgetown University ( Site 0036)	Washington D.C.	District of Columbia	Completed
University of Kentucky Markey Cancer Center ( Site 0019)	Lexington	Kentucky	Completed
MedStar Franklin Square Medical Center ( Site 0033)	Baltimore	Maryland	Completed
Massachusetts General Hospital ( Site 0003)	Boston	Massachusetts	Active Not Recruiting
Dana Farber Cancer Institute ( Site 0002)	Boston	Massachusetts	Active Not Recruiting
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)	Omaha	Nebraska	Completed
Dartmouth Hitchcock Medical Center ( Site 0016)	Lebanon	New Hampshire	Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)	Hackensack	New Jersey	Completed
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)	New York	New York	Completed
Sanford Fargo Medical Center ( Site 0039)	Fargo	North Dakota	Recruiting
Cleveland Clinic Main ( Site 0006)	Cleveland	Ohio	Completed
Ohio State University Comprehensive Cancer Center ( Site 0015)	Columbus	Ohio	Recruiting
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)	Philadelphia	Pennsylvania	Recruiting
Sanford Cancer Center ( Site 0038)	Sioux Falls	South Dakota	Recruiting
The University of Texas MD Anderson Cancer Center ( Site 0009)	Houston	Texas	Recruiting
Petz Aladar Megyei Oktato Korhaz ( Site 0062)	Győr	Győr-Moson-Sopron	Completed
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)	Szolnok	Jász-Nagykun-Szolnok	Completed
Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)	Budapest	Hungary	Completed
Soroka Medical Center ( Site 0072)	Beersheba	Israel	Completed
Rambam Health Care Campus-Oncology ( Site 0076)	Haifa	Israel	Completed
Shaare Zedek Medical Center ( Site 0075)	Jerusalem	Israel	Recruiting
Meir Medical Center ( Site 0071)	Kfar Saba	Israel	Completed
Rabin Medical Center ( Site 0074)	Petah Tikva	Israel	Completed
Chaim Sheba Medical Center ( Site 0070)	Ramat Gan	Israel	Recruiting
Sourasky Medical Center ( Site 0077)	Tel Aviv	Israel	Completed
Azienda Ospedaliera Universitaria Careggi ( Site 0173)	Florence	Firenze	Completed
IRCCS Ospedale San Raffaele ( Site 0171)	Milan	Italy	Completed
Policlinico Gemelli di Roma ( Site 0174)	Roma	Italy	Completed
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)	Warsaw	Masovian Voivodeship	Recruiting
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)	Gdansk	Pomeranian Voivodeship	Recruiting
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)	Koszalin	West Pomeranian Voivodeship	Active Not Recruiting
Seoul National University Bundang Hospital ( Site 0081)	Seongnam-si	Kyonggi-do	Completed
Severance Hospital ( Site 0080)	Seoul	South Korea	Completed
Samsung Medical Center ( Site 0082)	Seoul	South Korea	Completed
ICO L Hospitalet ( Site 0090)	L'Hospitalet de Llobregat	Barcelona	Recruiting
Hospital Clínic de Barcelona ( Site 0092)	Barcelona	Spain	Recruiting
Hospital Universitario Quiron Madrid ( Site 0091)	Madrid	Spain	Recruiting

+ 7 more sites — see the full list on the official registry below.

More Merck Sharp & Dohme LLC trials in Taiwan

A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) Active, not recruiting

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007) Active, not recruiting

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676) Active, not recruiting

A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04) Active, not recruiting

Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) Active, not recruiting

Other trials for the same condition

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer Active, not recruiting

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Active, not recruiting

A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer Active, not recruiting

Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation Active, not recruiting

A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04165798 on ClinicalTrials.gov ↗ ← All trials in Taiwan