Actively Recruiting
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
Led by Daiichi Sankyo · Updated on 2025-10-09
137
Participants Needed
45
Research Sites
286 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations
CONDITIONS
Official Title
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial procedures
- Adults aged 18 years or older at consent
- Histologically confirmed non-small cell lung cancer with no prior systemic therapy for advanced/metastatic disease
- Stage IIIB, IIIC not eligible for surgery or chemoradiation, or Stage IV disease
- Negative tests for EGFR, ALK, and ROS1 actionable genomic alterations
- No actionable genomic alterations in NTRK, BRAF, RET, MET, or other drivers with approved therapies
- Measurable disease on CT or MRI per RECIST v1.1
- Tumor PD-L1 expression with tumor proportion score of 50% or higher by local or central testing
- Provided formalin-fixed tumor tissue sample for biomarker assessment
- Eastern Cooperative Oncology Group performance status of 0 or 1 at screening
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or agents targeting T-cell receptors like CTLA-4, OX40, or CD137
- Prior treatment with any enhancer of zeste homolog inhibitors
- Received adjuvant or neoadjuvant therapy less than 6 months before advanced/metastatic diagnosis (except allowed therapies)
- Live or live attenuated vaccine within 30 days before first trial dose
- Active or suspected autoimmune disease requiring systemic treatment in past 2 years
- Immunodeficiency or chronic systemic steroid therapy exceeding 10 mg prednisone equivalent within 7 days before first trial dose
- Active or untreated central nervous system metastases or carcinomatous meningitis
- Uncontrolled or significant cardiovascular disease including recent myocardial infarction, uncontrolled angina, severe heart failure, uncontrolled hypertension, or prolonged QT interval
- History or current interstitial lung disease or pneumonitis requiring steroids, or suspected cases not ruled out by imaging
- History of radiation pneumonitis
- Prior allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
University of California San Diego (Ucsd)-Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
2
California Research Institute
Los Angeles, California, United States, 90027
Actively Recruiting
3
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
4
Mayo Clinic Hospital
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
5
BRCR Global
Plantation, Florida, United States, 33322-5426
Actively Recruiting
6
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
7
Pikeville Medical Center
Pikeville, Kentucky, United States, 41501
Actively Recruiting
8
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55904
Not Yet Recruiting
9
Columbia University Irving Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
10
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
11
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
12
Virginia Cancer Specialist
Fairfax, Virginia, United States, 22031
Actively Recruiting
13
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, 1199
Actively Recruiting
14
Instituto Alexander Fleming
Buenos Aires, Argentina, 1426
Actively Recruiting
15
Sanatorio Allende
Córdoba, Argentina, X5000JHQ
Not Yet Recruiting
16
Fundacion Ars Medica
N Salvador de Jujuy, Argentina, 4600
Not Yet Recruiting
17
Centro de Investigacion Pergamino Sa
Pergamino, Argentina, B2700CPM
Not Yet Recruiting
18
Instituto Medico de La Fundacion Estudios Clinicos
Rosario, Argentina, 2000
Not Yet Recruiting
19
Clinica Viedma S.A.
Viedma, Argentina, R8500ACE
Actively Recruiting
20
Centro de Pesquisas Clinica Reichow
Blumenau, Brazil, 89010-340
Actively Recruiting
21
Clínica de Neoplasias Litoral Ltda.
ItajaĂ-, Brazil, 88301-220
Not Yet Recruiting
22
CINPAM Centro Integrado De Pesquisa Da Amazonia
Manaus, Brazil, 69005-080
Actively Recruiting
23
Liga Norte-Rio-Grandense Contra o Câncer
Natal, Brazil, 59062-000
Actively Recruiting
24
Hospital Nossa Senhora da Conceicao
Porto Alegre, Brazil, 91350-280
Actively Recruiting
25
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, Brazil, 09060-650
Not Yet Recruiting
26
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose Rio Preto, Brazil, 15090-000
Actively Recruiting
27
Jilin Cancer Hospital
Changchun, China, 130000
Actively Recruiting
28
The First Hospital of Jilin University
Changchun, China, 130021
Not Yet Recruiting
29
Chengdu Shang Jin Nan Fu Hospital
Chengdu, China, 611730
Not Yet Recruiting
30
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, China, 242332
Actively Recruiting
31
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Actively Recruiting
32
Jiamusi Cancer Hospital
Jiamusi, China, 154007
Actively Recruiting
33
Shanghai East Hospital
Shanghai, China, 200120
Actively Recruiting
34
The First Hospital of China Medical University
Shenyang, China, 110001
Not Yet Recruiting
35
Tianjin Medical University Cancer Institute & Hospital
Tiyuan, China, 300060
Actively Recruiting
36
Henan Cancer Hospital
Zhengzhou, China, 450003
Actively Recruiting
37
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Actively Recruiting
38
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
39
Cancer Institute Hospital of JFCR
Kōtoku, Japan, 135-8550
Actively Recruiting
40
NHO Nagoya Medical Center
Nagoya, Japan, 460-0001
Actively Recruiting
41
Kitasato University Hospital
Sagamihara-shi, Japan, 252-0375
Actively Recruiting
42
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Not Yet Recruiting
43
Samsung Medical Center
Seoul, South Korea, 06351
Not Yet Recruiting
44
Seoul National University Hospital
Seoul, South Korea, 110-744
Not Yet Recruiting
45
The Catholic University of Korea, St. Vincent'S Hospital
Suwon, South Korea, 16247
Not Yet Recruiting
Research Team
C
Contact for Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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