NCT04165070 · Merck Sharp & Dohme LLC
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)
What this study is about
The purpose of this study is to assess the effectiveness 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.
View original scientific description
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).
Interventions
BIOLOGICAL
Pembrolizumab
IV infusion
DRUG
Carboplatin
IV infusion
DRUG
Paclitaxel
IV infusion
DRUG
Pemetrexed
IV infusion
BIOLOGICAL
Vibostolimab
IV infusion
BIOLOGICAL
Boserolimab
IV infusion
BIOLOGICAL
MK-4830
IV infusion
BIOLOGICAL
MK-0482
IV Infusion
BIOLOGICAL
Ifinatamab Deruxtecan (I-DXd)
IV infusion
BIOLOGICAL
HER3-DXd
IV Infusion
Primary outcome measures
Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 24 months
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR will be reported.
Part B: Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 27 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported.
Part B: Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (AE)
Time frame: Up to approximately 24 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study intervention due to an AE will be reported.
Part B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Time frame: Up to approximately 3 Weeks
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Number of participants who experience a DLT per CTCAE 5.0 will be reported.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy
- Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation
- Has not received prior systemic treatment for their metastatic NSCLC
- Is able to complete all screening procedures within the 35-day screening window for Part A and 28-day screening window for Part B
Exclusion criteria
- The main exclusion criteria include but are not limited to the following:
- Has a diagnosis of small cell lung cancer
- Has a diagnosis of immunodeficiency or is receivi
Where
- Gilbert, Arizona
- Duarte, California
- San Francisco, California
- Washington D.C., District of Columbia
- Lexington, Kentucky
- Baltimore, Maryland
- Boston, Massachusetts
- Omaha, Nebraska
- Lebanon, New Hampshire
- Hackensack, New Jersey
- New York, New York
- Fargo, North Dakota
And 5 more locations — see the full list below.
Collaborators
Daiichi Sankyo
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations