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)
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)
- Lung Neoplasm
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 144
- Started
- 28 May 2025
- Main results due
- 2 March 2032
- Study sites
- 45
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC) * 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: The main exclusion criteria include but are not limited to the following: * Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * 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 * Has clinically significant corneal disease * Has previously received docetaxel as monotherapy or in combination with other therapies * 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 * Has one or more of the following indicators of interstitial lung disease (ILD)/pneumonitis: any history of ILD/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current diagnosis of ILD, clinical or radiographic suspicion of ILD * 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
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(45)
University of Kentucky Chandler Medical Center ( Site 0019)
Lexington, Kentucky, United States
Recruiting
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, United States
Recruiting
Texas Oncology - DFW ( Site 8003)
Dallas, Texas, United States
Recruiting
Centro de Estudios Clínicos SAGA ( Site 0161)
Santiago, Region M. de Santiago, Chile
Recruiting
FALP ( Site 0160)
Santiago, Region M. de Santiago, Chile
Recruiting
Bradfordhill ( Site 0162)
Santiago, Region M. de Santiago, Chile
Recruiting
Beijing Cancer Hospital ( Site 0301)
Beijing, Beijing Municipality, China
Recruiting
Chongqing University Cancer Hospital ( Site 0304)
Chongqing, Chongqing Municipality, China
Recruiting
Fujian Provincial Cancer Hospital ( Site 0310)
Fuzhou, Fujian, China
Recruiting
Guangxi Medical University Cancer Hospital ( Site 0303)
Nanning, Guangxi, China
Recruiting
Henan Cancer Hospital ( Site 0311)
Zhengzhou, Henan, China
Recruiting
Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309)
Nanjing, Jiangsu, China
Recruiting
Shanghai Chest Hospital ( Site 0308)
Shanghai, Shanghai Municipality, China
Recruiting
Shanghai Pulmonary Hospital ( Site 0300)
Shanghai, Shanghai Municipality, China
Recruiting
UniversitaetsklInikum Tuebingen ( Site 0192)
Tübingen, Baden-Wurttemberg, Germany
Recruiting
Charite-Universitaetsmedizin Berlin ( Site 0191)
Berlin, Germany
Recruiting
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)
Athens, Attica, Greece
Recruiting
F. THERAPIS GENERAL ( Site 0206)
Athens, Attica, Greece
Recruiting
European Interbalkan Medical Center-Oncology Department ( Site 0205)
Thessaloniki, Greece
Recruiting
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
Kecskemét, Bács-Kiskun county, Hungary
Recruiting
Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
Győr, Győr-Moson-Sopron, Hungary
Recruiting
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Recruiting
Rambam Health Care Campus ( Site 0076)
Haifa, Israel
Recruiting
Shaare Zedek Medical Center ( Site 0075)
Jerusalem, Israel
Recruiting
Meir Medical Center ( Site 0071)
Kfar Saba, Israel
Recruiting
Rabin Medical Center ( Site 0074)
Petah Tikva, Israel
Recruiting
Sheba Medical Center ( Site 0070)
Ramat Gan, Israel
Recruiting
Sourasky Medical Center ( Site 0077)
Tel Aviv, Israel
Recruiting
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Italy
Recruiting
Ospedale San Raffaele. ( Site 0171)
Milan, Italy
Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
Milan, Italy
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
Roma, Italy
Recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)
Poznan, Greater Poland Voivodeship, Poland
Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
Warsaw, Masovian Voivodeship, Poland
Recruiting
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship, Poland
Recruiting
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
Koszalin, West Pomeranian Voivodeship, Poland
Recruiting
Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
L'Hospitalet de Llobregat, Barcelona, Spain
Recruiting
Hospital Clinic de Barcelona ( Site 0092)
Barcelona, Spain
Recruiting
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, Spain
Recruiting
Hospital Universitario Virgen Macarena ( Site 0094)
Seville, Spain
Recruiting
Ege Universitesi Hastanesi ( Site 0143)
Izmir, İzmir, Turkey (Türkiye)
Recruiting
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)
Adana, Turkey (Türkiye)
Recruiting
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
Ankara, Turkey (Türkiye)
Recruiting
Ankara Bilkent Şehir Hastanesi. ( Site 0142)
Ankara, Turkey (Türkiye)
Recruiting
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0144)
Istanbul, Turkey (Türkiye)
Recruiting
Showing 45 of 45 sites. 45 of the 45 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06780098. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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