Actively 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)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-01
144
Participants Needed
40
Research Sites
352 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)
- Documented disease progression per RECIST 1.1 after receiving anti-PD-1/PD-L1 treatment and platinum-based chemotherapy for Stage IV disease
- Well controlled HIV infection on antiretroviral therapy (ART) if HIV positive
- Hepatitis B surface antigen (HBsAg) positive participants eligible if on HBV antiviral therapy for at least 4 weeks with undetectable viral load
- Participants with history of Hepatitis C virus (HCV) infection eligible if HCV viral load is undetectable
You will not qualify if you...
- Diagnosis of small cell lung cancer or presence of small cell elements in mixed tumors
- Uncontrolled or significant cardiovascular disorder
- Severe pulmonary compromise from underlying pulmonary illness or autoimmune/connective tissue disorders affecting lungs, or prior pneumonectomy
- Adverse events from previous anticancer therapies must have recovered to Grade 1 or baseline (except alopecia)
- Clinically significant corneal disease
- Prior receipt of docetaxel as monotherapy or in combination
- Known progressing additional malignancy or treated within past 3 years
- Untreated central nervous system metastases or carcinomatous meningitis
- Evidence of leptomeningeal disease
- History or current interstitial lung disease/pneumonitis (except radiation pneumonitis not requiring steroids)
- Active autoimmune disease requiring systemic treatment in past 2 years (replacement therapy allowed)
- Active infection requiring systemic therapy
- HIV-infected with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Active inflammatory bowel disease requiring immunosuppressive medication or history of such diseases
- Known or active neurologic paraneoplastic syndrome
- History of allogeneic tissue or solid organ transplant
- Not adequately recovered from major surgery or ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
University of Kentucky Chandler Medical Center ( Site 0019)
Lexington, Kentucky, United States, 40536-0293
Actively Recruiting
2
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, United States, 21237
Actively Recruiting
3
Texas Oncology - DFW ( Site 8003)
Dallas, Texas, United States, 75246-2046
Actively Recruiting
4
Centro de Estudios Clínicos SAGA ( Site 0161)
Santiago, Region M. de Santiago, Chile, 7500653
Actively Recruiting
5
FALP ( Site 0160)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
6
Bradfordhill ( Site 0162)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
7
Chongqing University Cancer Hospital ( Site 0304)
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
8
Fujian Provincial Cancer Hospital ( Site 0310)
Fuzhou, Fujian, China, 350014
Actively Recruiting
9
Guangxi Medical University Cancer Hospital ( Site 0303)
Nanning, Guangxi, China, 530201
Actively Recruiting
10
Henan Cancer Hospital ( Site 0311)
Zhengzhou, Henan, China, 450000
Actively Recruiting
11
Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309)
Nanjing, Jiangsu, China, 210031
Actively Recruiting
12
Shanghai Chest Hospital ( Site 0308)
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
13
Shanghai Pulmonary Hospital ( Site 0300)
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
14
UniversitaetsklInikum Tuebingen ( Site 0192)
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
15
Charite-Universitaetsmedizin Berlin ( Site 0191)
Berlin, Germany, 13353
Actively Recruiting
16
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)
Athens, Attica, Greece, 115 27
Actively Recruiting
17
European Interbalkan Medical Center-Oncology Department ( Site 0205)
Thessaloniki, Greece, 570 01
Actively Recruiting
18
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
Kecskemét, Bács-Kiskun county, Hungary, 6000
Actively Recruiting
19
Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
Győr, Győr-Moson-Sopron, Hungary, 9024
Actively Recruiting
20
Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
Actively Recruiting
21
Rambam Health Care Campus ( Site 0076)
Haifa, Israel, 3109601
Actively Recruiting
22
Shaare Zedek Medical Center ( Site 0075)
Jerusalem, Israel, 9103102
Actively Recruiting
23
Meir Medical Center ( Site 0071)
Kfar Saba, Israel, 4428164
Actively Recruiting
24
Rabin Medical Center ( Site 0074)
Petah Tikva, Israel, 4941492
Actively Recruiting
25
Sheba Medical Center ( Site 0070)
Ramat Gan, Israel, 5265601
Actively Recruiting
26
Sourasky Medical Center ( Site 0077)
Tel Aviv, Israel, 6423906
Actively Recruiting
27
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Italy, 50134
Actively Recruiting
28
Ospedale San Raffaele. ( Site 0171)
Milan, Italy, 20132
Actively Recruiting
29
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
Milan, Italy, 20133
Actively Recruiting
30
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
Roma, Italy, 00168
Actively Recruiting
31
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)
Poznan, Greater Poland Voivodeship, Poland, 60-569
Actively Recruiting
32
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
33
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Actively Recruiting
34
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
Koszalin, West Pomeranian Voivodeship, Poland, 75-581
Actively Recruiting
35
Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
36
Hospital Clinic de Barcelona ( Site 0092)
Barcelona, Spain, 08008
Actively Recruiting
37
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, Spain, 28223
Actively Recruiting
38
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)
Adana, Turkey (Türkiye), 01250
Actively Recruiting
39
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
40
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0144)
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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