Investigating Pembrolizumab Alone or With Chemotherapy for Non-Small Cell Lung Cancer
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)
Run by Merck Sharp & Dohme LLC · NCT04165798 · Data updated 2026-11-12
This study is testing whether the drug pembrolizumab, alone or with chemotherapy, can help people with non-small cell lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1065 (estimated) |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | pembrolizumab, chemotherapy |
| Locations | 48 sites (Gilbert, Arizona and 47 other locations) |
| Status | Recruiting |
| Started | December 19, 2019 |
| Main results expected | February 13, 2032 |
| Study ends | February 13, 2032 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT04165798 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with histologically-confirmed Stage IV squamous or nonsquamous NSCLC who have not received prior systemic treatment.
✕Probably not a fit
Patients with preexisting moderate neuropathy or those who have received prior systemic treatment for metastatic NSCLC may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This umbrella master protocol study aims to screen participants with non-small cell lung cancer (NSCLC) for enrollment into one of seven substudies evaluating the efficacy of pembrolizumab, both alone and in combination with chemotherapy or other investigational agents. Participants will first enroll in the master protocol and undergo screening to determine their eligibility for specific substudies based on their cancer characteristics and treatment history. The study utilizes a platform design to facilitate the evaluation of multiple treatment combinations in a structured manner.
Why it matters
Potential benefit: If successful, this study could provide new treatment options for patients with advanced non-small cell lung cancer.
How similar studies have gone: Other studies using similar umbrella protocols have shown promise in evaluating combination therapies for various cancers, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Dartmouth Hitchcock Medical Center ( Site 0016)
Lebanon, New Hampshire, United States Recruiting -
Sanford Fargo Medical Center ( Site 0039)
Fargo, North Dakota, United States Recruiting -
Ohio State University Comprehensive Cancer Center ( Site 0015)
Columbus, Ohio, United States Recruiting -
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)
Philadelphia, Pennsylvania, United States Recruiting -
Sanford Cancer Center ( Site 0038)
Sioux Falls, South Dakota, United States Recruiting -
The University of Texas MD Anderson Cancer Center ( Site 0009)
Houston, Texas, United States Recruiting
Show 42 more locations
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Cross Cancer Institute ( Site 0291)
Edmonton, Alberta, Canada Recruiting -
Shaare Zedek Medical Center ( Site 0075)
Jerusalem, Israel Recruiting -
Chaim Sheba Medical Center ( Site 0070)
Ramat Gan, Israel Recruiting -
Hospital Clinic de Barcelona ( Site 0092)
Barcelona, Spain Recruiting -
Changhua Christian Hospital ( Site 0181)
Changhua, Taiwan Recruiting -
Taipei Medical University Hospital ( Site 0180)
Taipei, Taiwan Recruiting -
Chang Gung Medical Foundation-Linkou Branch ( Site 0182)
Taoyuan, Taiwan Recruiting -
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)
Cherkasy, Cherkasy Oblast, Ukraine Recruiting -
Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 0460)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine Recruiting -
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)
Rivne, Rivne Oblast, Ukraine Recruiting -
Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)
Uzhhorod, Zakarpattia Oblast, Ukraine Recruiting -
Banner MD Anderson Cancer Center ( Site 0001)
Gilbert, Arizona, United States Completed -
City of Hope ( Site 0014)
Duarte, California, United States Completed -
UCSF Medical Center at Mission Bay ( Site 0007)
San Francisco, California, United States Completed -
Georgetown University ( Site 0036)
Washington D.C., District of Columbia, United States Completed -
University of Kentucky Markey Cancer Center ( Site 0019)
Lexington, Kentucky, United States Completed -
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, United States Completed -
Massachusetts General Hospital ( Site 0003)
Boston, Massachusetts, United States Completed -
Dana Farber Cancer Institute ( Site 0002)
Boston, Massachusetts, United States Completed -
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)
Omaha, Nebraska, United States Completed -
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)
Hackensack, New Jersey, United States Completed -
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)
New York, New York, United States Completed -
Cleveland Clinic Main ( Site 0006)
Cleveland, Ohio, United States Completed -
Petz Aladar Megyei Oktato Korhaz ( Site 0062)
Győr, Győr-Moson-Sopron, Hungary Completed -
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok, Hungary 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 -
Meir Medical Center ( Site 0071)
Kfar Saba, Israel Completed -
Rabin Medical Center ( Site 0074)
Petah Tikva, Israel Completed -
Sourasky Medical Center ( Site 0077)
Tel Aviv, Israel Completed -
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Firenze, Italy 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, Poland Completed -
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship, Poland Completed -
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)
Koszalin, West Pomeranian Voivodeship, Poland Active not recruiting -
Seoul National University Bundang Hospital ( Site 0081)
Seongnam-si, Kyonggi-do, South Korea 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, Spain Completed -
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, Spain Completed
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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PF-08634404 plus chemotherapy versus pembrolizumab-based chemotherapy for advanced non-small cell lung cancer
This will test whether PF-08634404 combined with chemotherapy works better than pembrolizumab plus chemotherapy for adults with locally advanced or metastatic non-small cell lung cancer who have not received prior treatment for their advanced disease.
-
Combining adagrasib, pembrolizumab, and chemotherapy for lung cancer with a specific mutation
This study is testing a new treatment combining adagrasib, pembrolizumab, and chemotherapy to see if it helps people with a specific type of lung cancer that has a KRAS G12C mutation.
-
Comparing rilvegostomig and pembrolizumab for treating advanced lung cancer
This study is testing whether a new drug called rilvegostomig works better than pembrolizumab for treating advanced lung cancer in patients whose tumors have a specific marker.
-
Combining Sigvotatug Vedotin and Pembrolizumab for Non-Small Cell Lung Cancer
This study is testing a new combination of two treatments, Sigvotatug Vedotin and pembrolizumab, to see if it helps people with advanced non-small cell lung cancer feel better compared to just using pembrolizumab alone.
-
Combining pembrolizumab with intismeran autogene for non-small cell lung cancer treatment
This study is testing if a new combination of a gene therapy and a cancer drug can help people with non-small cell lung cancer stay cancer-free after surgery.
-
Efficacy and safety of pembrolizumab with or without chemotherapy for advanced lung cancer
This study is testing if adding pembrolizumab to chemotherapy helps people with advanced lung cancer feel better and live longer compared to using pembrolizumab alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.