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Study identifier: NCT06780098 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

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)

Condition: Lung Neoplasm  ·  Sponsor: Merck Sharp & Dohme LLC

PhasePhase 2
Planned participants144
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Toll Free Number  ·  1-888-577-8839  ·  Trialsites@msd.com

Always discuss trial participation with your own doctor first.

Locations (44)

University of Kentucky Chandler Medical Center ( Site 0019)Lexington, Kentucky, United StatesRecruiting
MedStar Franklin Square Medical Center ( Site 0033)Baltimore, Maryland, United StatesRecruiting
Texas Oncology - DFW ( Site 8003)Dallas, Texas, United StatesRecruiting
Centro de Estudios Clínicos SAGA ( Site 0161)Santiago, Region M. de Santiago, ChileRecruiting
FALP ( Site 0160)Santiago, Region M. de Santiago, ChileRecruiting
Bradfordhill ( Site 0162)Santiago, Region M. de Santiago, ChileRecruiting
Beijing Cancer Hospital ( Site 0301)Beijing, Beijing Municipality, ChinaRecruiting
Chongqing University Cancer Hospital ( Site 0304)Chongqing, Chongqing Municipality, ChinaRecruiting
Fujian Provincial Cancer Hospital ( Site 0310)Fuzhou, Fujian, ChinaRecruiting
Guangxi Medical University Cancer Hospital ( Site 0303)Nanning, Guangxi, ChinaRecruiting
Henan Cancer Hospital ( Site 0311)Zhengzhou, Henan, ChinaRecruiting
Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309)Nanjing, Jiangsu, ChinaRecruiting

+ 32 more locations — full list on the registry record.

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