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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)
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

RecruitingN/A

Sponsor: Merck Sharp & Dohme LLC

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Tumor Imaging, Tumor Tissue Collection, Blood Sample Collection

Countries: United States, Hungary, Israel, Italy, Poland, South Korea, Spain, Taiwan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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
Locations (47)
  • Gilbert, Arizona, United States
  • Duarte, California, United States
  • San Francisco, California, United States
  • Washington D.C., District of Columbia, United States
  • Lexington, Kentucky, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Omaha, Nebraska, United States
  • Lebanon, New Hampshire, United States
  • Hackensack, New Jersey, United States
  • New York, New York, United States
  • Fargo, North Dakota, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Sioux Falls, South Dakota, United States
  • Houston, Texas, United States
  • Győr, Győr-Moson-Sopron, Hungary
  • Szolnok, Jász-Nagykun-Szolnok, Hungary
  • Budapest, Hungary
  • Beersheba, Israel
  • Haifa, Israel
  • Jerusalem, Israel
  • Kfar Saba, Israel
  • Petah Tikva, Israel
  • Ramat Gan, Israel
  • Tel Aviv, Israel
  • Florence, Firenze, Italy
  • Milan, Italy
  • + 17 more on CT.gov