KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Public ClinicalTrials.gov record NCT04165070. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Study identification
- NCT ID
- NCT04165070
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 450 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Carboplatin Drug
- Paclitaxel Drug
- Pemetrexed Drug
- Vibostolimab Biological
- Boserolimab Biological
- MK-4830 Biological
- MK-0482 Biological
- Ifinatamab Deruxtecan (I-DXd) Biological
- HER3-DXd Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 18, 2019
- Primary completion
- Feb 12, 2032
- Completion
- Oct 12, 2032
- Last update posted
- Aug 24, 2026
2019 – 2032
United States locations
- U.S. sites
- 18
- U.S. states
- 15
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0001) | Gilbert | Arizona | 85234 | Completed |
| City of Hope ( Site 0014) | Duarte | California | 91010 | Completed |
| UCSF Medical Center at Mission Bay ( Site 0007) | San Francisco | California | 94158 | Completed |
| Georgetown University ( Site 0036) | Washington D.C. | District of Columbia | 20007 | Completed |
| University of Kentucky Markey Cancer Center ( Site 0019) | Lexington | Kentucky | 40536-0293 | Completed |
| MedStar Franklin Square Medical Center ( Site 0033) | Baltimore | Maryland | 21237 | Completed |
| Massachusetts General Hospital ( Site 0003) | Boston | Massachusetts | 02114 | Completed |
| Dana Farber Cancer Institute ( Site 0002) | Boston | Massachusetts | 02215 | Completed |
| Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) | Omaha | Nebraska | 68130 | Completed |
| Dartmouth Hitchcock Medical Center ( Site 0016) | Lebanon | New Hampshire | 03766 | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) | Hackensack | New Jersey | 07601 | Completed |
| Laura and Isaac Perlmutter Cancer Center ( Site 0034) | New York | New York | 10016 | Completed |
| Sanford Fargo Medical Center ( Site 0039) | Fargo | North Dakota | 58102 | Recruiting |
| Cleveland Clinic Main ( Site 0006) | Cleveland | Ohio | 44195 | Completed |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015) | Columbus | Ohio | 43210 | Recruiting |
| Abramson Cancer Center of the University of Pennsylvania ( Site 0010) | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Sanford Cancer Center ( Site 0038) | Sioux Falls | South Dakota | 57104 | Recruiting |
| The University of Texas MD Anderson Cancer Center ( Site 0009) | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04165070, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04165070 live on ClinicalTrials.gov.