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Active Not RecruitingPhase 2NCT06788912
Official study title

Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)

Study summary

The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPembrolizumab (neoadjuvant) and Cisplatin

Plus 11 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 13, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2

Interventional

Where is it offered?39 U.S. locations

Locations may change over time.

Who runs it?Merck Sharp & Dohme LLC

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Merck Sharp & Dohme LLC
Interventions being studied
Biological: Pembrolizumab (neoadjuvant); Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Sacituzumab tirumotecan; Drug: H1 receptor antagonist; Drug: H2 receptor antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Carboplatin; Biological: Pembrolizumab (adjuvant); Drug: Paclitaxel; Drug: Steroid mouthwash (dexamethasone or equivalent)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→
Treatment approach
Immunotherapy→Chemotherapy→Surgery→
Study topics
Before surgery (neoadjuvant)→
03
Public criteria

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.

Requirements people may need to meetInclusion criteria

The main inclusion and

Reasons someone may not be able to joinExclusion criteria
  • include but are not limited to the following: Inclusion Criteria:
  • Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC)
  • Able to undergo protocol therapy, including necessary surgery
  • Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.
  • Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Southern Cancer Center (SCC) ( Site 8004)Daphne, Alabama
  • Sansum Clinic (Ridley Tree) ( Site 8012)Santa Barbara, California
  • Rocky Mountain Cancer Centers (RMCC) ( Site 8011)Lone Tree, Colorado
  • Greenebaum Comprehensive Cancer Center ( Site 0402)Baltimore, Maryland
  • MedStar Franklin Square Medical Center ( Site 0033)Baltimore, Maryland
  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006)Eugene, Oregon
  • Texas Oncology - Central/South Texas ( Site 8009)Austin, Texas
  • Texas Oncology - Northeast Texas ( Site 8005)Tyler, Texas
  • Virginia Cancer Specialists (VCS) ( Site 8002)Fairfax, Virginia
  • Centro de Estudios Clínicos SAGA ( Site 0162)Santiago, Region M. de Santiago
  • FALP ( Site 0161)Santiago, Region M. de Santiago
  • Bradfordhill ( Site 0160)Santiago, Region M. de Santiago

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 13, 2026. Always confirm current availability with the study team.

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