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NCT06788912PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

3/20/2025

Completion Date

2/6/2032

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.

Eligibility Criteria

Age Range: 18 years to No maximum

The main inclusion and exclusion 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. Exclusion Criteria: * Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor. * Has Grade ≥2 peripheral neuropathy. * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing. * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea). * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids. * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. * Known additional malignancy that is progressing or has required active treatment within the past 5 years. * Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Active infection requiring systemic therapy. * Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) \[qualitative\]) infection. * Known history of human immunodeficiency virus (HIV) infection. * History of allogeneic tissue/solid organ transplant.

Interventions

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)

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Conditions

Lung Neoplasm Malignant

Locations

Southern Cancer Center (SCC) ( Site 8004)

Daphne, Alabama 36526

United States

Sansum Clinic (Ridley Tree) ( Site 8012)

Santa Barbara, California 93105

United States

Rocky Mountain Cancer Centers (RMCC) ( Site 8011)

Lone Tree, Colorado 80124

United States

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland 21237

United States

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006)

Eugene, Oregon 97401

United States

Texas Oncology - Central/South Texas ( Site 8009)

Austin, Texas 78705

United States

Texas Oncology - Northeast Texas ( Site 8005)

Tyler, Texas 75702

United States

Virginia Cancer Specialists (VCS) ( Site 8002)

Fairfax, Virginia 22031

United States

Centro de Estudios Clínicos SAGA ( Site 0162)

Santiago, Region M. de Santiago 7500653

Chile

FALP ( Site 0161)

Santiago, Region M. de Santiago 7500921

Chile

Bradfordhill ( Site 0160)

Santiago, Region M. de Santiago 8420383

Chile

Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)

Athens, Attica 115 28

Greece

ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202)

Athens, Attica 12462

Greece

Metropolitan Hospital-4th Oncology Dept ( Site 0201)

Athens, Attica 185 47

Greece

University General Hospital of Heraklion ( Site 0200)

Heraklion, Irakleio 71110

Greece

Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062)

Győr, Győr-Moson-Sopron 9024

Hungary

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0061)

Szolnok, Jász-Nagykun-Szolnok 5000

Hungary

Országos Korányi Pulmonológiai Intézet ( Site 0060)

Budapest, 1121

Hungary

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, Tuscany 50134

Italy

Ospedale San Raffaele. ( Site 0171)

Milan, 20132

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)

Milan, 20133

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)

Roma, 00168

Italy

Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)

Poznan, Greater Poland Voivodeship 60-569

Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)

Warsaw, Masovian Voivodeship 02-781

Poland

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

Gdansk, Pomeranian Voivodeship 80-952

Poland

Hospital Clinic de Barcelona ( Site 0092)

Barcelona, 08008

Spain

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0702)

Adana, 01250

Turkey (Türkiye)

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)

Ankara, 06230

Turkey (Türkiye)

Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 0704)

Antalya, 07059

Turkey (Türkiye)

İzmir Suat Seren Chest Disease Training & Research Hospital ( Site 0701)

Izmir, 35110

Turkey (Türkiye)

Ondokuz Mayıs Universitesi-Oncology department ( Site 0706)

Samsun, 55139

Turkey (Türkiye)

CNE CC of Oncology Hematol ( Site 0130)

Cherkasy, Cherkasy Oblast 18009

Ukraine

Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0139)

Chernivtsi, Chernivetska Oblast 58013

Ukraine

CNCE Precarpathian Clinical Oncologic Center ( Site 0131)

Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018

Ukraine

MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)

Lviv, Lviv Oblast 79059

Ukraine

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)

Rivne, Rivne Oblast 33010

Ukraine

Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0135)

Vinnytsia, Vinnytsia Oblast 21029

Ukraine

Shalimov Institute of Surgery and Transplantation ( Site 0138)

Kyiv, 03126

Ukraine