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)
| NCT ID | NCT04165798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,065 participants |
| Start Date | 2019-12-19 |
| Primary Completion | 2032-02-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,065 participants in total. It began in 2019-12-19 with a primary completion date of 2032-02-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT04165798 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma, Non-Small-Cell Lung. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04165798 currently recruiting?
Yes, NCT04165798 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT04165798 trial being conducted?
This trial is being conducted at Gilbert, United States, Duarte, United States, San Francisco, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT04165798 clinical trial?
NCT04165798 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 1,065 participants.