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)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tumor Imaging
  • Tumor Tissue Collection
  • Blood Sample Collection

Treatment groups

1,065 Participants
are divided into 1 treatment group

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Daiichi Sankyo

Collaborator