Clinical trial Recruiting at 17 sites Observational Ages 18 and up

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.

More Carcinoma, Non-Small-Cell Lung trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1065 (estimated)
SponsorMerck Sharp & Dohme LLC
Industry-sponsored
Drugs / interventionspembrolizumab, chemotherapy
Locations48 sites (Gilbert, Arizona and 47 other locations)
StatusRecruiting
StartedDecember 19, 2019
Main results expectedFebruary 13, 2032
Study endsFebruary 13, 2032
Registry record updatedOctober 29, 2026
Trial IDNCT04165798 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.