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)
NCT ID: NCT06780098
Last Updated: 2026-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
144 participants
INTERVENTIONAL
2025-05-28
2032-03-02
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm 1: Raludotatug deruxtecan (R-DXD)
Participants receive 5.6 mg/kg of R-DXD, every 3 weeks (Q3W) (Day 1 of every 21-day cycle) via intravenous (IV) infusion until progressive disease (PD) or discontinuation.
R-DXD
IV Infusion
Arm 2: Infinatamab deruxtecan (I-DXD) High Dose
Participants receive 12 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.
I-DXD
IV Infusion
Arm 3: I-DXD Low Dose
Participants receive 8 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.
I-DXD
IV Infusion
Arm 4: Docetaxel
Participants receive 75 mg/m\^2 of Docetaxel, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.
Docetaxel
IV Infusion
Interventions
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R-DXD
IV Infusion
I-DXD
IV Infusion
Docetaxel
IV Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has documented disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an anti-programmed cell death protein 1 (anti-PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy for Stage IV disease
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria
* Has uncontrolled or significant cardiovascular disorder
* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy
* Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
* Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including HIV infection)
* Has clinically significant corneal disease
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
* Evidence of any leptomeningeal disease
* History of (noninfectious) pneumonitis/Interstitial Lung Disease (ILD) that required steroids or has current pneumonitis/ILD, and/or suspected ILD/pneumonitis
* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* Active infection requiring systemic therapy
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
* Known history of, or active, neurologic paraneoplastic syndrome
* History of allogeneic tissue/solid organ transplant
* Has not adequately recovered from major surgery or have ongoing surgical complications
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Hospital Clinic de Barcelona ( Site 0092)
Barcelona, , Spain
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, , Spain
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0144)
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475-01I
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1314-2392
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-518839-11-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
KEYMAKER-01I
Identifier Type: OTHER
Identifier Source: secondary_id
3475-01I
Identifier Type: -
Identifier Source: org_study_id
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