New combo aims to boost lung cancer treatment

NCT ID NCT06644768

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests whether adding valemetostat to the standard immunotherapy pembrolizumab works better than pembrolizumab alone for people with advanced non-small cell lung cancer that has high PD-L1 levels. About 137 adults who have not had prior treatment will participate. The goal is to see if the combination can delay cancer growth and improve response rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: valemetostat tosylate and pembrolizumab
What this could lead to: If successful, this combination could offer a new first-line treatment option for people with advanced lung cancer that has high PD-L1 levels.
What could go wrong: This is an early-phase trial (1b/2) with only 137 participants, so results may not confirm benefit. Adding valemetostat may increase side effects without improving outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 137 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Has signed and dated the ICF, prior to the start of any trial-specific qualification procedures. 2. Is an adult ≥18 years of age or the minimum legal age (whichever is greater) at the time of informed consent. (Follow local regulatory requirements if the legal age of adult voluntary consent for trial participation is \>18 years old). 3. Has histologically documented NSCLC that meets all of the following criteria: 1. Has no prior systemic therapy for advanced or metastatic disease. 2. Has Stage IIIB or IIIC disease and is not a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of enrollment/randomization (based on the American Joint Committee on Cancer, Eighth Edition). Participants with early-stage NSCLC who have relapsed should be restaged during Screening to ensure their eligibility for the trial. 3. Has documented negative test results for EGFR, ALK, and ROS1 actionable genomic alterations based on analysis of tumor tissue. If test results for EGFR, ALK, and ROS1 are not available, participants are required to undergo testing with approved and/or validated tests per local regulations for these genomic alterations. Participants with squamous NSCLC are only required to undergo EGFR, ALK, and ROS1 testing if they have no history of tobacco smoking or were diagnosed with NSCLC at \<40 years of age. 4. Has no known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable oncogenic drivers with locally approved therapies (testing for genomic alterations besides EGFR, ALK, and ROS1 is not required prior to enrollment/randomization). Participants whose tumors harbor KRAS mutations are eligible for the trial. 4. Has measurable disease on CT or MRI based on local imaging assessment using RECIST v1.1 5. Has a tumor expressing PD-L1 TPS ≥50% as determined by local testing using 22C3 pharmDx PD-L1 IHC assay. In regions where PD-L1 (TPS ≥50%) testing by 22C3 pharmDx is not considered SOC, PD-L1 expression levels will be determined by central testing (minimum of 6 slides). 6. Has provided an archival formalin-fixed tumor tissue sample for the assessment of biomarkers. If archival tissue is not available, a new pretreatment biopsy is required, if clinically feasible. 7. Has an ECOG PS of 0 or 1 at Screening. Key Exclusion Criteria 1. Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting: 1. Any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, or CD137). 2. Has previously been treated with any enhancer of zeste homolog inhibitors. 2. Participants who received adjuvant or neoadjuvant therapy other than those listed in the exclusion criterion above are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the current diagnosis of advanced or metastatic disease. 3. Has received a live vaccine or live attenuated vaccine within 30 days prior to the first dose of trial intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccines. Note: Administration of killed vaccines is allowed. 4. Has an active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years- except for Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid). Inhaled, intranasal, intraocular, intra-articular, or topical steroids and adrenal replacement steroids are permitted in the absence of active autoimmune disease. 5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (at doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial intervention. Note: Short-course systemic corticosteroids (eg, prevention of/treatment for transfusion reaction) or steroid use for a noncancer indication (eg, adrenal replacement) is permissible. 6. Has a known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate, provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks by repeat imaging (note: repeat imaging should be performed during trial screening), clinically stable, and without requirement of steroid treatment for at least 14 days before the first dose of trial intervention. Note: A CT scan or MRI scan of the brain at Baseline is required for all participants. For participants in whom CNS metastases are first discovered at Screening, the treating investigator should delay trial intervention to complete any necessary treatment followed by a proper washout period and document the stability of CNS metastases with repeat imaging at least 4 weeks later (in which case repetition of all screening activities may be required). 7. Has uncontrolled or significant cardiovascular disease, including the following: 1. Mean QT interval corrected for heart rate using Fridericia's formula \>470 ms (based on the average of screening triplicate 12-lead ECG determinations) 2. Myocardial infarction within 6 months prior to Screening 3. Uncontrolled angina pectoris within 6 months prior to Screening 4. New York Heart Association Class 3 or 4 congestive heart failure 5. Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg) 8. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. 9. Has a history of radiation pneumonitis. 10. Has had an allogenic tissue/solid organ transplant.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung cancer Non-small cell lung cancer

Contacts and locations

Locations

BRCR Global

Plantation, Florida, 33322-5426, United States
CINPAM Centro Integrado De Pesquisa Da Amazonia

Manaus, 69005-080, Brazil
California Research Institute

Los Angeles, California, 90027, United States
Cancer Institute Hospital of JFCR

Kōtoku, 135-8550, Japan
Centro de Pesquisas Clinica Reichow

Blumenau, 89010-340, Brazil
Clinica Viedma S.A.

Viedma, R8500ACE, Argentina
Clínica de Neoplasias Litoral Ltda.

ItajaĂ-, 88301-220, Brazil
Columbia University Irving Medical Center

New York, New York, 10032, United States
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

Sao Jose Rio Preto, 15090-000, Brazil
Fundacion Ars Medica

N Salvador de Jujuy, 4600, Argentina
Harbin Medical University Cancer Hospital

Harbin, 150081, China
Henan Cancer Hospital

Zhengzhou, 450003, China
Hospital Italiano de Buenos Aires

Buenos Aires, 1199, Argentina
Hospital Nossa Senhora da Conceicao

Porto Alegre, 91350-280, Brazil
Instituto Alexander Fleming

Buenos Aires, 1426, Argentina
Instituto Medico de La Fundacion Estudios Clinicos

Rosario, 2000, Argentina
Jiamusi Cancer Hospital

Jiamusi, 154007, China
Jilin Cancer Hospital

Changchun, 130000, China
Kitasato University Hospital

Sagamihara-shi, 252-0375, Japan
Kyushu University Hospital

Fukuoka, 812-8582, Japan
Liga Norte-Rio-Grandense Contra o Câncer

Natal, 59062-000, Brazil
Mayo Clinic - Rochester

Rochester, Minnesota, 55904, United States
Mayo Clinic Hospital

Jacksonville, Florida, 32224, United States
NHO Nagoya Medical Center

Nagoya, 460-0001, Japan
National Cancer Center Hospital East

Kashiwa, 277-8577, Japan
Pikeville Medical Center

Pikeville, Kentucky, 41501, United States
Sanatorio Allende

Córdoba, X5000JHQ, Argentina
Shanghai East Hospital

Shanghai, 200120, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, 242332, China
Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States
Tianjin Medical University Cancer Institute & Hospital

Tiyuan, 300060, China
University of California San Diego (Ucsd)-Moores Cancer Center

La Jolla, California, 92037, United States
University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States
Valkyrie Clinical Trials

Los Angeles, California, 90067, United States
Virginia Cancer Specialist

Fairfax, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.