A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)
Researchers are investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. This study aims to determine the effectiveness of adding other treatments, including the human epidermal growth factor receptor 3-directed antibody-drug conjugate (HER3-DXd) patritumab deruxtecan, to pembrolizumab, with or without chemotherapy. The primary goals are to assess safety and efficacy of the treatments.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 4 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 16, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Merck Sharp & Dohme LLC
- Interventions being studied
- Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Pemetrexed; Biological: HER3-DXd
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- The main inclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Staging Manual Version 8.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 7 days before randomization.
- Has archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on ART.
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to treatment randomization.
The main
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Kentucky ( Site 0019)Lexington, Kentucky
- MedStar Franklin Square Medical Center ( Site 0033)Baltimore, Maryland
- Sanford Fargo Medical Center ( Site 0039)Fargo, North Dakota
- Abramson Cancer Center ( Site 0010)Philadelphia, Pennsylvania
- Sanford Cancer Center ( Site 0038)Sioux Falls, South Dakota
- Centro de Estudios Clínicos SAGA ( Site 0162)Santiago, Region M. de Santiago
- Fundación Arturo López Pérez ( Site 0161)Santiago, Region M. de Santiago
- Bradfordhill ( Site 0160)Santiago, Region M. de Santiago
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204)Athens, Attica
- European Interbalkan Medical Center-Oncology Department ( Site 0205)Thessaloniki
- Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)Győr, Győr-Moson-Sopron
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)Szolnok, Jász-Nagykun-Szolnok
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 16, 2026. Always confirm current availability with the study team.