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Recruiting
NCT04165798
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)
Conditions: Carcinoma, Non-Small-Cell Lung
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1065
Sponsor: Merck Sharp & Dohme LLC
Location: Banner MD Anderson Cancer Center ( Site 0001) Gilbert Arizona
Summary
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 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
Source: ClinicalTrials.gov (NCT04165798). StuddyBuddy aggregates publicly available trial information.