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A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs. Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing. However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells. Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn: * About the safety of the study treatments and if people tolerate them * How many people have the cancer respond to the study treatments
Official title: KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2025-05-13
Completion Date
2032-03-12
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
Raludotatug Deruxtecan
IV Infusion
Ifinatamab Deruxtecan
IV Infusion
Docetetaxel
IV Infusion
5-hydroxytryptamine subtype 3 receptor antagonist
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
Neurokinin-1 receptor antagonist
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
Corticosteroid
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration
Locations (31)
University of Kentucky Chandler Medical Center ( Site 0019)
Lexington, Kentucky, United States
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, United States
Centro de Estudios Clínicos SAGA ( Site 0161)
Santiago, Region M. de Santiago, Chile
FALP ( Site 0160)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0162)
Santiago, Region M. de Santiago, Chile
Universitaetsklinik Tuebingen ( Site 0192)
Tübingen, Baden-Wurttemberg, Germany
Charite-Universitaetsmedizin Berlin ( Site 0191)
Berlin, Germany
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204)
Athens, Attica, Greece
European Interbalkan Medical Center ( Site 0205)
Thessaloniki, Greece
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
Kecskemét, Bács-Kiskun county, Hungary
Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
Győr, Győr-Moson-Sopron, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Rambam Health Care Campus ( Site 0076)
Haifa, Israel
Shaare Zedek Medical Center ( Site 0075)
Jerusalem, Israel
Meir Medical Center ( Site 0071)
Kfar Saba, Israel
Rabin Medical Center ( Site 0074)
Petah Tikva, Israel
Sheba Medical Center ( Site 0070)
Ramat Gan, Israel
Sourasky Medical Center ( Site 0077)
Tel Aviv, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Italy
Ospedale San Raffaele. ( Site 0171)
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
Roma, Italy
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)
Poznan, Greater Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
Koszalin, West Pomeranian Voivodeship, Poland
Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, Spain
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)
Adana, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
Ankara, Turkey (Türkiye)
I. U. Cerrahpasa Tip Fakultesi ( Site 0144)
Istanbul, Turkey (Türkiye)