RecruitingPhase 1Phase 2NCT06644768

A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations

A Multicenter, Randomized, Open-Label, Phase 1b/2 Trial Of Valemetostat Tosylate Plus Pembrolizumab Vs Pembrolizumab Alone in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 With Tumor Proportion Score ≥50% Without Actionable Genomic Alterations

Sponsor

Daiichi Sankyo

Enrollment

137 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Non-small Cell Lung Cancer

Summary

This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new combination treatment — valemetostat tosylate plus pembrolizumab — against pembrolizumab alone as a first-line treatment for advanced non-small cell lung cancer (NSCLC) in patients whose tumors have high levels of a protein called PD-L1 and no common targetable gene mutations. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with stage IIIB, IIIC, or IV non-small cell lung cancer - You have not previously received systemic treatment for advanced or metastatic disease - Your tumor tests negative for EGFR, ALK, and ROS1 mutations - Your tumor has high PD-L1 expression (TPS ≥ 50%) - You have measurable disease on imaging - You are in good physical health (ECOG score 0 or 1) **You may NOT be eligible if...** - Your tumor has actionable mutations in EGFR, ALK, ROS1, BRAF, NTRK, RET, or MET - You have already received chemotherapy or immunotherapy for this cancer - You have active autoimmune disease, uncontrolled infections, or significant lung or heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGvalemetostat tosylate

Valemetostat will be administered orally once daily until RP2D of valemetostat is determined.

DRUGpembrolizumab

One IV infusion Q3W on D1 of each 21-day cycle for a maximum of 35 cycles.

Locations(45)

University of California San Diego (Ucsd)-Moores Cancer Center

La Jolla, California, United States

California Research Institute

Los Angeles, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Mayo Clinic Hospital

Jacksonville, Florida, United States

BRCR Global

Plantation, Florida, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Pikeville Medical Center

Pikeville, Kentucky, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Columbia University Irving Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

Virginia Cancer Specialist

Fairfax, Virginia, United States

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

Sanatorio Allende

Córdoba, Argentina

Fundacion Ars Medica

N Salvador de Jujuy, Argentina

Centro de Investigacion Pergamino Sa

Pergamino, Argentina

Instituto Medico de La Fundacion Estudios Clinicos

Rosario, Argentina

Clinica Viedma S.A.

Viedma, Argentina

Centro de Pesquisas Clinica Reichow

Blumenau, Brazil

Clínica de Neoplasias Litoral Ltda.

ItajaĂ-, Brazil

CINPAM Centro Integrado De Pesquisa Da Amazonia

Manaus, Brazil

Liga Norte-Rio-Grandense Contra o Câncer

Natal, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Brazil

Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

Santo André, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

Sao Jose Rio Preto, Brazil

Jilin Cancer Hospital

Changchun, China

The First Hospital of Jilin University

Changchun, China

Chengdu Shang Jin Nan Fu Hospital

Chengdu, China

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Jiamusi Cancer Hospital

Jiamusi, China

Shanghai East Hospital

Shanghai, China

The First Hospital of China Medical University

Shenyang, China

Tianjin Medical University Cancer Institute & Hospital

Tiyuan, China

Henan Cancer Hospital

Zhengzhou, China

Kyushu University Hospital

Fukuoka, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

NHO Nagoya Medical Center

Nagoya, Japan

Kitasato University Hospital

Sagamihara-shi, Japan

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

The Catholic University of Korea, St. Vincent'S Hospital

Suwon, South Korea

View Full Details on ClinicalTrials.gov

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NCT06644768

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