Actively Recruiting
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-12
96
Participants Needed
33
Research Sites
356 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 new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs. Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing. However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells. Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn: * About the safety of the study treatments and if people tolerate them * How many people have the cancer respond to the study treatments
CONDITIONS
Official Title
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed Stage IV nonsquamous non-small cell lung cancer (NSCLC)
- Disease progression after anti-PD-1/PD-L1 treatment and platinum-based chemotherapy
- Negative for EGFR, ALK, ROS1, or other targeted therapy indications per local test
- Measurable disease by RECIST 1.1 assessed by investigator and verified by BICR
- Life expectancy of at least 3 months
- ECOG performance status of 0 to 1 within 7 days before randomization
- At least 18 years of age and any sex/gender
- Adequate organ function
- If able to produce sperm, refrains from donating sperm and uses contraception or abstains from penile-vaginal intercourse
- Childbearing potential participants are not pregnant, not breastfeeding, and use highly effective contraception
- Provided archival tumor tissue sample not previously irradiated
- Provided new biopsy tissue sample prior to treatment randomization
- HIV-infected participants must have well-controlled HIV on antiretroviral therapy
- Hepatitis B positive participants must have received antiviral therapy for at least 4 weeks and have undetectable viral load
- Hepatitis C history participants eligible if viral load undetectable at screening
You will not qualify if you...
- Diagnosis of small cell lung cancer or tumors with small cell elements
- Received radiation therapy to the lung
- Uncontrolled or significant cardiovascular disorder prior to randomization
- Clinically severe pulmonary compromise from other pulmonary illnesses
- Unresolved adverse events from prior anticancer therapies (except alopecia) above Grade 1 or baseline
- Severe hypersensitivity (Grade 3 or higher) to study treatment or its components
- Clinically significant corneal disease
- Received prior radiotherapy within 2 weeks before study intervention or corticosteroid-requiring radiation toxicities
- Inadequate washout period before randomization
- Received live or live-attenuated vaccine within 30 days before first study dose
- Diagnosed with immunodeficiency or on chronic systemic steroid therapy
- Previously received docetaxel alone or with other therapies
- Received investigational agent or device within 4 weeks before study intervention
- Other progressing malignancy requiring treatment within past 3 years
- Untreated central nervous system metastases or carcinomatous meningitis
- Evidence of leptomeningeal disease
- History or current diagnosis of interstitial lung disease or pneumonitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infection needing systemic therapy
- HIV-infected with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Active inflammatory bowel disease needing immunosuppressive medication or history of such disease
- 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
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 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
Universitaetsklinik Tuebingen ( Site 0192)
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
8
Charite-Universitaetsmedizin Berlin ( Site 0191)
Berlin, Germany, 13353
Actively Recruiting
9
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204)
Athens, Attica, Greece, 115 27
Actively Recruiting
10
European Interbalkan Medical Center ( Site 0205)
Thessaloniki, Greece, 570 01
Actively Recruiting
11
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
Kecskemét, Bács-Kiskun county, Hungary, 6000
Actively Recruiting
12
Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
Győr, Győr-Moson-Sopron, Hungary, 9024
Actively Recruiting
13
Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
Actively Recruiting
14
Rambam Health Care Campus ( Site 0076)
Haifa, Israel, 3109601
Actively Recruiting
15
Shaare Zedek Medical Center ( Site 0075)
Jerusalem, Israel, 9103102
Actively Recruiting
16
Meir Medical Center ( Site 0071)
Kfar Saba, Israel, 4428164
Actively Recruiting
17
Rabin Medical Center ( Site 0074)
Petah Tikva, Israel, 4941492
Actively Recruiting
18
Sheba Medical Center ( Site 0070)
Ramat Gan, Israel, 5265601
Actively Recruiting
19
Sourasky Medical Center ( Site 0077)
Tel Aviv, Israel, 6423906
Actively Recruiting
20
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
Milan, Lombardy, Italy, 20133
Actively Recruiting
21
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Italy, 50134
Actively Recruiting
22
Ospedale San Raffaele. ( Site 0171)
Milan, Italy, 20132
Actively Recruiting
23
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
Roma, Italy, 00168
Actively Recruiting
24
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)
Poznan, Greater Poland Voivodeship, Poland, 60-569
Actively Recruiting
25
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
26
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Actively Recruiting
27
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
Koszalin, West Pomeranian Voivodeship, Poland, 75-581
Actively Recruiting
28
Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
29
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, Spain, 28223
Actively Recruiting
30
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)
Adana, Turkey (Türkiye), 01250
Actively Recruiting
31
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
32
Ankara Bilkent Şehir Hastanesi. ( Site 0142)
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
33
I. U. 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
3
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