Actively Recruiting
KEYMAKER-U01 Substudy 01I: A Randomized Phase 2 Study of Investigational Agents Versus Docetaxel in Previously Treated Stage IV Squamous Non-small Cell Lung Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-26
144
Participants Needed
40
Research Sites
N/A
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 investigating new treatment options for metastatic squamous non-small cell lung cancer (NSCLC), a type of lung cancer that begins in the flat cells lining the airways and has spread to other parts of the body. This study focuses on patients whose cancer did not respond to standard immunotherapy and chemotherapy. It aims to compare the cancer response and safety of investigational antibody drug conjugates (ADCs) against chemotherapy under a master protocol framework. Participants are randomly assigned to one of four groups receiving different treatments via intravenous infusion every three weeks: 5.6 mg/kg of raludotatug deruxtecan (R-DXD), either 12 mg/kg or 8 mg/kg of infinotamab deruxtecan (I-DXD) at high or low doses, or 75 mg/m^2 of docetaxel chemotherapy. Treatment continues until the cancer progresses or participants discontinue. Some participants may also receive rescue medications like corticosteroids and receptor antagonists as needed. During the study, participant health and cancer response will be regularly monitored through assessments that include measuring tumor response and tracking adverse events for up to approximately 81 months. Researchers will also evaluate how long responses last, progression-free survival, and overall survival. Safety and tolerability will be closely observed, and participants will have ongoing evaluations throughout the study duration.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- 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
- HIV-infected participants must have well-controlled HIV on antiretroviral therapy
- Participants positive for Hepatitis B surface antigen must have received antiviral therapy for at least 4 weeks and have undetectable viral load
- Participants with history of Hepatitis C virus infection must have undetectable viral load
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 disorders
- Severe pulmonary compromise from lung illnesses or autoimmune/connective tissue diseases affecting the lungs
- Adverse events from previous anticancer therapies not recovered to Grade 1 or baseline (except hair loss)
- Clinically significant corneal disease
- Prior treatment with docetaxel alone or in combination
- Active or progressing additional malignancies requiring treatment within past 3 years
- Untreated central nervous system metastases or carcinomatous meningitis
- Evidence of leptomeningeal disease
- History or signs of interstitial lung disease or pneumonitis
- Active autoimmune disease requiring systemic treatment within past 2 years (replacement therapy allowed)
- Active infection requiring systemic therapy
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Active inflammatory bowel disease requiring immunosuppressive medication or history of such diseases
- Known history or presence of neurologic paraneoplastic syndrome
- History of allogeneic tissue or solid organ transplant
- Incomplete recovery from major surgery or ongoing surgical complications
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until progressive disease or discontinuation
Participants receive one of the investigational agents or docetaxel via intravenous infusion every 3 weeks until disease progression or discontinuation.
Visits every 3 weeks for intravenous infusions
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
Centro de Estudios Clínicos SAGA ( Site 0161)
Santiago, Region M. de Santiago, Chile, 7500653
Actively Recruiting
4
FALP ( Site 0160)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
5
Bradfordhill ( Site 0162)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
6
Chongqing University Cancer Hospital ( Site 0304)
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
7
Fujian Provincial Cancer Hospital ( Site 0310)
Fuzhou, Fujian, China, 350014
Actively Recruiting
8
Guangxi Medical University Cancer Hospital ( Site 0303)
Nanning, Guangxi, China, 530201
Actively Recruiting
9
Henan Cancer Hospital ( Site 0311)
Zhengzhou, Henan, China, 450000
Actively Recruiting
10
Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309)
Nanjing, Jiangsu, China, 210031
Actively Recruiting
11
Shanghai Chest Hospital ( Site 0308)
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
12
Shanghai Pulmonary Hospital ( Site 0300)
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
13
UniversitaetsklInikum Tuebingen ( Site 0192)
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
14
Charite-Universitaetsmedizin Berlin ( Site 0191)
Berlin, Germany, 13353
Actively Recruiting
15
EVANGELISMOS S.A ( Site 0206)
Athens, Attica, Greece, 106 76
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 Varmegyei Hetenyi Geza 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
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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