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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)

Sponsored by Merck Sharp & Dohme LLC

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.

The following pembrolizumab substudies will evaluate the efficacy of different investigational agents in combination with pembrolizumab given in sequence or in combination with pembrolizumab PLUS chemotherapy: * KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A) - NCT04165070 * KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Treatment Naïve Patients with PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B) - NCT04165083 * KEYMAKER-U01 Substudy 3: A Phase 2, Umbrella Study with Rolling Arms of Inves…

Where this study is enrolling (6)

  • Dartmouth Hitchcock Medical Center ( Site 0016)

    Lebanon, New Hampshire

    Call 603-650-4428

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  • Sanford Fargo Medical Center ( Site 0039)

    Fargo, North Dakota

    Call 701-234-2000

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  • Ohio State University Comprehensive Cancer Center ( Site 0015)

    Columbus, Ohio

    Call 614-366-0233

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  • Abramson Cancer Center of the University of Pennsylvania ( Site 0010)

    Philadelphia, Pennsylvania

    Call 215-220-9703

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  • Sanford Cancer Center ( Site 0038)

    Sioux Falls, South Dakota

    Call 605-328-8000

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Show all 6 locations

  • The University of Texas MD Anderson Cancer Center ( Site 0009)

    Houston, Texas

    Call 877-632-6789

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.