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RECRUITING

NCT06788912

PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-03-20

Completion Date

2032-02-06

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Lung Neoplasm Malignant

Interventions

BIOLOGICAL

Pembrolizumab (neoadjuvant)

Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles

DRUG

Cisplatin

Cisplatin 75 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles

DRUG

Gemcitabine

In squamous tumors Gemcitabine 1000 mg/m\^2 by IV infusion on day 1 and day 8 of each 21-day cycle for 4 cycles.

DRUG

Pemetrexed

In nonsquamous tumors Pemetrexed 500 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles

DRUG

Sacituzumab tirumotecan

Sacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles

DRUG

H1 receptor antagonist

Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

DRUG

H2 receptor antagonist

Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

DRUG

Acetaminophen (or equivalent)

Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

DRUG

Dexamethasone (or equivalent)

Administered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label

DRUG

Carboplatin

AUC 5 mg/mL min or AUC 6 mg/mL min by IV infusion on day 1 of each 21-day cycle for 4 cycles

BIOLOGICAL

Pembrolizumab (adjuvant)

After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles

DRUG

Paclitaxel

Paclitaxel 175 or 200 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles.

DRUG

Steroid mouthwash (dexamethasone or equivalent)

Administered orally as rescue medication 2-5 mL 4 times daily

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.

Locations (34)

Southern Cancer Center (SCC) ( Site 8004)

Daphne, Alabama, United States

Sansum Clinic (Ridley Tree) ( Site 8012)

Santa Barbara, California, United States

Rocky Mountain Cancer Centers (RMCC) ( Site 8011)

Lone Tree, Colorado, United States

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland, United States

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

Eugene, Oregon, United States

Texas Oncology - Central/South Texas ( Site 8009)

Austin, Texas, United States

Texas Oncology - Northeast Texas ( Site 8005)

Tyler, Texas, United States

Virginia Cancer Specialists (VCS) ( Site 8002)

Fairfax, Virginia, United States

Centro de Estudios Clínicos SAGA ( Site 0162)

Santiago, Region M. de Santiago, Chile

FALP ( Site 0161)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0160)

Santiago, Region M. de Santiago, Chile

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

Athens, Attica, Greece

ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202)

Athens, Attica, Greece

Metropolitan Hospital-4th Oncology Dept ( Site 0201)

Athens, Attica, Greece

University General Hospital of Heraklion ( Site 0200)

Heraklion, Irakleio, Greece

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

Győr, Győr-Moson-Sopron, Hungary

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

Szolnok, Jász-Nagykun-Szolnok, Hungary

Országos Korányi Pulmonológiai Intézet ( Site 0060)

Budapest, Hungary

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, Tuscany, Italy

Ospedale San Raffaele. ( Site 0171)

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)

Milan, Italy

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

Roma, Italy

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

Poznan, Greater Poland Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

Hospital Clínic de Barcelona ( Site 0092)

Barcelona, Spain

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)

Ankara, Turkey (Türkiye)

CNE CC of Oncology Hematol ( Site 0130)

Cherkasy, Cherkasy Oblast, Ukraine

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

Chernivtsi, Chernivetska Oblast, Ukraine

CNCE Precarpathian Clinical Oncologic Center ( Site 0131)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

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

Lviv, Lviv Oblast, Ukraine

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)

Rivne, Rivne Oblast, Ukraine

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

Vinnytsia, Vinnytsia Oblast, Ukraine

Shalimov Institute of Surgery and Transplantation ( Site 0138)

Kyiv, Ukraine

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (34)