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RECRUITING
NCT06780085
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Raludotatug Deruxtecan

IV Infusion

BIOLOGICAL

Ifinatamab Deruxtecan

IV Infusion

DRUG

Docetetaxel

IV Infusion

DRUG

5-hydroxytryptamine subtype 3 receptor antagonist

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion

DRUG

Neurokinin-1 receptor antagonist

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion

DRUG

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)