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)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rak płuca typu płaskonabłonkowego, stadium IV.
- •Choroba, która postąpiła mimo standardowego leczenia (immunoterapia i chemioterapia).
- •Osoby z wirusem HIV muszą mieć dobrze kontrolowany wirus na lekach.
- •Osoby z wirusem zapalenia wątroby typu B muszą być leczone i mieć niewykrywalny poziom wirusa.
- •Osoby po przebyciu zapalenia wątroby typu C muszą mieć niewykrywalny poziom wirusa.
✗ Disqualifies
- •Rak płuca o innym typie niż płaskonabłonkowy lub mieszany.
- •Nieprawidłowości w pracy serca, które są trudne do opanowania.
- •Poważne problemy z płucami spowodowane innymi chorobami (np. zatorowość płucna, astma, POChP) lub choroby autoimmunologiczne z zajęciem płuc.
- •Poprzednie leczenie przeciwnowotworowe musiało się zakończyć bez poważnych, utrzymujących się skutków ubocznych (poza wypadaniem włosów).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (44)
University of Kentucky Chandler Medical Center ( Site 0019)
Lexington, United States
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, United States
Texas Oncology - DFW ( Site 8003)
Dallas, United States
Centro de Estudios Clínicos SAGA ( Site 0161)
Santiago, Chile
FALP ( Site 0160)
Santiago, Chile
Bradfordhill ( Site 0162)
Santiago, Chile
Beijing Cancer Hospital ( Site 0301)
Beijing, China
Chongqing University Cancer Hospital ( Site 0304)
Chongqing, China
Fujian Provincial Cancer Hospital ( Site 0310)
Fuzhou, China
Guangxi Medical University Cancer Hospital ( Site 0303)
Nanning, China
Henan Cancer Hospital ( Site 0311)
Zhengzhou, China
Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309)
Nanjing, China
Shanghai Chest Hospital ( Site 0308)
Shanghai, China
Shanghai Pulmonary Hospital ( Site 0300)
Shanghai, China
UniversitaetsklInikum Tuebingen ( Site 0192)
Tübingen, Germany
Charite-Universitaetsmedizin Berlin ( Site 0191)
Berlin, Germany
EVANGELISMOS S.A ( Site 0206)
Athens, Greece
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)
Athens, Greece
European Interbalkan Medical Center-Oncology Department ( Site 0205)
Thessaloniki, Greece
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
Kecskemét, Hungary
Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
Győr, Hungary
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)
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, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
Koszalin, Poland
Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
L'Hospitalet de Llobregat, Spain
Hospital Clinic de Barcelona ( Site 0092)
Barcelona, Spain
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, Spain
Ege Universitesi Hastanesi ( Site 0143)
Izmir, Turkey (Türkiye)
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)
Ankara Bilkent Şehir Hastanesi. ( Site 0142)
Ankara, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0144)
Istanbul, Turkey (Türkiye)
Trial contact
Toll Free Number
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/7/2026.
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