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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)

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About this study

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.

Condition
Carcinoma, Non-Small-Cell Lung
Tested
Tumor Imaging, Tumor Tissue Collection, Blood Sample Collection
Sponsor
Merck Sharp & Dohme LLC

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 5

  • Minimum age: 18 years
  • Study condition: Carcinoma, Non-Small-Cell Lung
  • 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 4

  • 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

47 sites, 20 recruiting

Shaare Zedek Medical Center ( Site 0075)

Jerusalem, Israel

Recruiting

Chaim Sheba Medical Center ( Site 0070)

Ramat Gan, Israel

Recruiting

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

Gdansk, Pomeranian Voivodeship, Poland

Recruiting

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

Warsaw, Masovian Voivodeship, Poland

Recruiting

Hospital Clínic de Barcelona ( Site 0092)

Barcelona, Spain

Recruiting

ICO L Hospitalet ( Site 0090)

L'Hospitalet de Llobregat, Barcelona, Spain

Recruiting

and 41 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.