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
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cross Cancer Institute ( Site 0291) Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Hospital Clinic de Barcelona ( Site 0092) Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| ICO L Hospitalet ( Site 0090) Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario Quiron Madrid ( Site 0091) Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Országos Korányi Pulmonológiai Intézet ( Site 0060) Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Petz Aladar Megyei Oktato Korhaz ( Site 0062) Coordinator of this site? Confirm its status | Győr | Hungary | Completed |
| Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061) Coordinator of this site? Confirm its status | Szolnok | Hungary | Completed |
| Soroka Medical Center ( Site 0072) Coordinator of this site? Confirm its status | Beersheba | Israel | Completed |
| Rambam Health Care Campus-Oncology ( Site 0076) Coordinator of this site? Confirm its status | Haifa | Israel | Completed |
| Shaare Zedek Medical Center ( Site 0075) Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Meir Medical Center ( Site 0071) Coordinator of this site? Confirm its status | Kfar Saba | Israel | Completed |
| Rabin Medical Center ( Site 0074) Coordinator of this site? Confirm its status | Petah Tikva | Israel | Completed |
| Chaim Sheba Medical Center ( Site 0070) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center ( Site 0077) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Completed |
| Azienda Ospedaliera Universitaria Careggi ( Site 0173) Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| IRCCS Ospedale San Raffaele ( Site 0171) Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Policlinico Gemelli di Roma ( Site 0174) Coordinator of this site? Confirm its status | Roma | Italy | Completed |
| Seoul National University Bundang Hospital ( Site 0081) Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Completed |
| Severance Hospital ( Site 0080) Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| Samsung Medical Center ( Site 0082) Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150) Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152) Coordinator of this site? Confirm its status | Koszalin | Poland | Active, 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 | Warsaw | Poland | Completed |
| Changhua Christian Hospital ( Site 0181) Coordinator of this site? Confirm its status | Changhua | Taiwan | Recruiting |
| Taipei Medical University Hospital ( Site 0180) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Medical Foundation-Linkou Branch ( Site 0182) Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463) Coordinator of this site? Confirm its status | Cherkasy | Ukraine | Recruiting |
| Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 0460) Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Recruiting |
| ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461) Coordinator of this site? Confirm its status | Rivne | Ukraine | Recruiting |
| Uzhhorod Multispecialty City Clinical Hospital ( Site 0462) Coordinator of this site? Confirm its status | Uzhhorod | Ukraine | Recruiting |
| MedStar Franklin Square Medical Center ( Site 0033) Coordinator of this site? Confirm its status | Baltimore | United States | Completed |
| Massachusetts General Hospital ( Site 0003) Coordinator of this site? Confirm its status | Boston | United States | Completed |
| Dana Farber Cancer Institute ( Site 0002) Coordinator of this site? Confirm its status | Boston | United States | Completed |
| Cleveland Clinic Main ( Site 0006) Coordinator of this site? Confirm its status | Cleveland | United States | Completed |
| Ohio State University Comprehensive Cancer Center ( Site 0015) Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| City of Hope ( Site 0014) Coordinator of this site? Confirm its status | Duarte | United States | Completed |
| Sanford Fargo Medical Center ( Site 0039) Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Banner MD Anderson Cancer Center ( Site 0001) Coordinator of this site? Confirm its status | Gilbert | United States | Completed |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) Coordinator of this site? Confirm its status | Hackensack | United States | Completed |
| The University of Texas MD Anderson Cancer Center ( Site 0009) Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Dartmouth Hitchcock Medical Center ( Site 0016) Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
| University of Kentucky Markey Cancer Center ( Site 0019) Coordinator of this site? Confirm its status | Lexington | United States | Completed |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034) Coordinator of this site? Confirm its status | New York | United States | Completed |
| Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) Coordinator of this site? Confirm its status | Omaha | United States | Completed |
| Abramson Cancer Center of the University of Pennsylvania ( Site 0010) Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| UCSF Medical Center at Mission Bay ( Site 0007) Coordinator of this site? Confirm its status | San Francisco | United States | Completed |
| Sanford Cancer Center ( Site 0038) Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Georgetown University ( Site 0036) Coordinator of this site? Confirm its status | Washington D.C. | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.