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RECRUITING
NCT06780098
PHASE2

Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Researchers are looking for other ways to treat metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is cancer that starts in squamous cells, which are flat cells that line the inside of the airways in the lungs. Metastatic means the cancer has spread to other parts of the body. Standard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC. Researchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goals of this study are to learn about: * The cancer response to the study treatments compared to chemotherapy * The safety of the study treatments and if people tolerate them This study is one of the substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

Official title: KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2025-05-28

Completion Date

2032-03-02

Last Updated

2026-04-01

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

R-DXD

IV Infusion

BIOLOGICAL

I-DXD

IV Infusion

DRUG

Docetaxel

IV Infusion

DRUG

Rescue Medications

Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines.

DRUG

Rescue Medication

Participants are premedicated with corticosteroids per approved product label and following institutional standards or local guidelines.

Locations (39)

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

Chongqing University Cancer Hospital ( Site 0304)

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital ( Site 0310)

Fuzhou, Fujian, China

Guangxi Medical University Cancer Hospital ( Site 0303)

Nanning, Guangxi, China

Henan Cancer Hospital ( Site 0311)

Zhengzhou, Henan, China

Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309)

Nanjing, Jiangsu, China

Shanghai Chest Hospital ( Site 0308)

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital ( Site 0300)

Shanghai, Shanghai Municipality, China

UniversitaetsklInikum Tuebingen ( Site 0192)

Tübingen, Baden-Wurttemberg, Germany

Charite-Universitaetsmedizin Berlin ( Site 0191)

Berlin, Germany

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)

Athens, Attica, Greece

European Interbalkan Medical Center-Oncology Department ( 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

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, 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 ( 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 Clinic de Barcelona ( Site 0092)

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)

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0144)

Istanbul, Turkey (Türkiye)