Non-small Cell Lung CancerPhase 1/2NCT06644768
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
A Phase 1/2 study testing valemetostat tosylate and pembrolizumab in people with Non-small Cell Lung Cancer and Lung Cancer, run by Daiichi Sankyo at 35 sites in 5 countries.
Trial summary
This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Lung Cancer
- What is being tested?
- valemetostat tosylate and pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 35 sitesin 5 countries
- Study dates
- 30 Oct 2024to 30 Apr 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signed and dated the ICF, prior to the start of any trial-specific qualification procedures.
- 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).
- Has histologically documented NSCLC that meets all of the following criteria:
- Has no prior systemic therapy for advanced or metastatic disease.
- 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.
- 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.
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- 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.
- 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.
- Has measurable disease on CT or MRI based on local imaging assessment using RECIST v1.1
- 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).
- 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.
- Has an ECOG PS of 0 or 1 at Screening.
Who cannot join
- Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting:
- 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).
- Has previously been treated with any enhancer of zeste homolog inhibitors.
- 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.
- 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.
- 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).
Show all 18Show fewer
- Inhaled, intranasal, intraocular, intra-articular, or topical steroids and adrenal replacement steroids are permitted in the absence of active autoimmune disease.
- 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.
- 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).
- Has uncontrolled or significant cardiovascular disease, including the following:
- Mean QT interval corrected for heart rate using Fridericia's formula >470 ms (based on the average of screening triplicate 12-lead ECG determinations)
- Myocardial infarction within 6 months prior to Screening
- Uncontrolled angina pectoris within 6 months prior to Screening
- New York Heart Association Class 3 or 4 congestive heart failure
- Uncontrolled hypertension (resting systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
- 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.
- Has a history of radiation pneumonitis.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
United States11 sites
Virginia Cancer Specialist
Fairfax, Virginia, 22031
Mayo Clinic Hospital
Jacksonville, Florida, 32224
University of California San Diego (Ucsd)-Moores Cancer Center
La Jolla, California, 92037
University of Kentucky Medical Center
Lexington, Kentucky, 40536
California Research Institute
Los Angeles, California, 90027
Valkyrie Clinical Trials
Los Angeles, California, 90067
Columbia University Irving Medical Center
New York, New York, 10032
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Pikeville Medical Center
Pikeville, Kentucky, 41501
BRCR Global
Plantation, Florida, 33322-5426
Mayo Clinic - Rochester
Rochester, Minnesota, 55904
China7 sites
Jilin Cancer Hospital
Changchun, 130000
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 242332
Harbin Medical University Cancer Hospital
Harbin, 150081
Jiamusi Cancer Hospital
Jiamusi, 154007
Shanghai East Hospital
Shanghai, 200120
Tianjin Medical University Cancer Institute & Hospital
Tiyuan, 300060
Henan Cancer Hospital
Zhengzhou, 450003
Argentina6 sites
Hospital Italiano de Buenos Aires
Buenos Aires, 1199
Instituto Alexander Fleming
Buenos Aires, 1426
Sanatorio Allende
Córdoba, X5000JHQ
Fundacion Ars Medica
N Salvador de Jujuy, 4600
Instituto Medico de La Fundacion Estudios Clinicos
Rosario, 2000
Clinica Viedma S.A.
Viedma, R8500ACE
Brazil6 sites
Centro de Pesquisas Clinica Reichow
Blumenau, 89010-340
Clínica de Neoplasias Litoral Ltda.
ItajaĂ-, 88301-220
CINPAM Centro Integrado De Pesquisa Da Amazonia
Manaus, 69005-080
Liga Norte-Rio-Grandense Contra o Câncer
Natal, 59062-000
Hospital Nossa Senhora da Conceicao
Porto Alegre, 91350-280
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose Rio Preto, 15090-000
Japan5 sites
Kyushu University Hospital
Fukuoka, 812-8582
National Cancer Center Hospital East
Kashiwa, 277-8577
Cancer Institute Hospital of JFCR
Kōtoku, 135-8550
NHO Nagoya Medical Center
Nagoya, 460-0001
Kitasato University Hospital
Sagamihara-shi, 252-0375
About this study
Official title: 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
This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations
Read the detailed description
This trial will evaluate the safety and efficacy of valemetostat tosylate (DS-3201b) in combination with fixed-dose pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic NSCLC without actionable genomic alterations, whose tumor has PD-L1 TPS ≥50%, and who have not received prior systemic therapy for advanced or metastatic NSCLC. The trial will be in 2 phases, dose escalation and dose expansion phases.
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer
- Being tested
- valemetostat tosylate, pembrolizumab
- Keywords
- NSCLC, Tumor, pembrolizumab, valemetostat tosylate, DS-3201b, Immune checkpoint inhibitor, Programmed Cell Death 1 Ligand 1, MK-3475, EZH inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valemetostat tosylateDrug
Also called DS-3201b, valemetostat
Valemetostat will be administered orally once daily until RP2D of valemetostat is determined.
pembrolizumabDrug
Also called MK-3475, KEYTRUDA®
One IV infusion Q3W on D1 of each 21-day cycle for a maximum of 35 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b: Pembrolizumab + Valemetostat Tosylate | Experimental | Participants will be provided with pembrolizumab at standard dose of 200 mg intravenously (IV) Q3W, and valemetostat will be provided per a dose escalation schedule, with an initial starting dose of 150 mg by mouth once daily. Receives: Drug: valemetostat tosylate; Drug: pembrolizumab |
| Phase 2: Pembrolizumab + Valemetostat Tosylate | Experimental | Participants will be provided with pembrolizumab at standard dose of 200 mg IV Q3W, and valemetostat will be provided per recommended phase 2 dose (RP2D) Receives: Drug: valemetostat tosylate; Drug: pembrolizumab |
| Phase 2: Pembrolizumab | Active comparator | Participants will be provided with pembrolizumab at standard dose of 200 mg IV Q3W Receives: Drug: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Number of Participants with Dose-Limiting Toxicities
Total number of participants with A Dose-Limiting Toxicity (DLT) at each dose level of valemetostat in combination with pembrolizumab per National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0.
Measured: From day of first dose on Day 1 to Day 21 in Cycle 1 (21 days), or before the administration of Cycle 2, up to 24 days
Phase 1b: Number of Participants with Treatment-Emergent Adverse Events
Incidence of TEAEs, Grade 3 or 4 TEAEs, deaths, TESAEs, TEAEs leading to dose modifications (including interruption, reduction, and discontinuation), and AESIs using the National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0
Measured: From date of first dose to 30 days after last dose, up to approximately 31 months
Phase 2: Progression-Free Survival by BICR
PFS is the time from the date of randomization to the date of radiographic disease progression as assessed by blinded independent central review (BICR) per RECIST v1.1 or death from any cause, whichever occurs first.
Measured: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
Secondary outcomes (6)
Phase 2: Objective Response Rate
Objective Response Rate (ORR) is the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR.
Measured: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
Phase 2: Duration of Response
Duration of Response (DoR) is the time from the date of first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the date of the first documentation of objective tumor progression or to death from any cause, whichever occurs first, assessed by BICR.
Measured: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
Phase 2: Disease Control Rate
Disease control rate (DCR) is the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by BICR.
Measured: From date of randomization up to approximately 31 months
Phase 2: Overall Survival
Overall Survival (OS ) is the time from the date of randomization to the date of death from any cause.
Measured: From date of randomization the date of death from any cause, up to approximately 31 months
Phase 2: Progression-Free Survival by Investigator
PFS is the time from the date of randomization to the date of radiographic disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first.
Measured: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
Phase 1 and 2: Total and Unbound Plasma Concentration of Valemetostat
Measured: Cycle 1: Day 1- Pre-dose, 2, 4, 5 hrs post-dose, Day 8- Pre-dose, Day 15- Pre-dose and post-dose. Cycles 2- 5: Day 1- Pre-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start30 Oct 2024
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open-label study.
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644768
- Sponsor's protocol ID
- DS3201-330
- Other IDs
- MK-3475-F85, KEYNOTE-F85, 2024-519671-26-00, jRCT2031240572
- Status last verified
- Jul 2026
- First submitted
- 1 Oct 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06644768
- Acronym / sponsor ID
- DS3201-330
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer
- Keywords
- NSCLC, Tumor, pembrolizumab, valemetostat tosylate, DS-3201b, Immune checkpoint inhibitor, Programmed Cell Death 1 Ligand 1, MK-3475
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations
Detailed description
This trial will evaluate the safety and efficacy of valemetostat tosylate (DS-3201b) in combination with fixed-dose pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic NSCLC without actionable genomic alterations, whose tumor has PD-L1 TPS ≥50%, and who have not received prior systemic therapy for advanced or metastatic NSCLC. The trial will be in 2 phases, dose escalation and dose expansion phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an open-label study.
| Arm | Type | Receives |
|---|---|---|
| Phase 1b: Pembrolizumab + Valemetostat Tosylate | Experimental | Drug: valemetostat tosylate, Drug: pembrolizumabParticipants will be provided with pembrolizumab at standard dose of 200 mg intravenously (IV) Q3W, and valemetostat will be provided per a dose escalation schedule, with an initial starting dose of 150 mg by mouth once daily. |
| Phase 2: Pembrolizumab + Valemetostat Tosylate | Experimental | Drug: valemetostat tosylate, Drug: pembrolizumabParticipants will be provided with pembrolizumab at standard dose of 200 mg IV Q3W, and valemetostat will be provided per recommended phase 2 dose (RP2D) |
| Phase 2: Pembrolizumab | Active comparator | Drug: pembrolizumabParticipants will be provided with pembrolizumab at standard dose of 200 mg IV Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Has signed and dated the ICF, prior to the start of any trial-specific qualification procedures.
- 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).
- Has histologically documented NSCLC that meets all of the following criteria:
- 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.
- Has measurable disease on CT or MRI based on local imaging assessment using RECIST v1.1
Key exclusion criteria (18 listed)
- Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting:
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valemetostat tosylateAlso: DS-3201b, valemetostatValemetostat will be administered orally once daily until RP2D of valemetostat is determined. | Drug | Phase 1b: Pembrolizumab + Valemetostat Tosylate, Phase 2: Pembrolizumab + Valemetostat Tosylate |
| pembrolizumabAlso: MK-3475, KEYTRUDA®One IV infusion Q3W on D1 of each 21-day cycle for a maximum of 35 cycles. | Drug | Phase 1b: Pembrolizumab + Valemetostat Tosylate, Phase 2: Pembrolizumab, Phase 2: Pembrolizumab + Valemetostat Tosylate |
Primary outcome
Phase 1b: Number of Participants with Dose-Limiting Toxicities
Time frame: From day of first dose on Day 1 to Day 21 in Cycle 1 (21 days), or before the administration of Cycle 2, up to 24 days
Total number of participants with A Dose-Limiting Toxicity (DLT) at each dose level of valemetostat in combination with pembrolizumab per National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0.
Phase 1b: Number of Participants with Treatment-Emergent Adverse Events
Time frame: From date of first dose to 30 days after last dose, up to approximately 31 months
Incidence of TEAEs, Grade 3 or 4 TEAEs, deaths, TESAEs, TEAEs leading to dose modifications (including interruption, reduction, and discontinuation), and AESIs using the National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0
Phase 2: Progression-Free Survival by BICR
Time frame: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
PFS is the time from the date of randomization to the date of radiographic disease progression as assessed by blinded independent central review (BICR) per RECIST v1.1 or death from any cause, whichever occurs first.
6 secondary outcomes
Phase 2: Objective Response Rate
Time frame: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
Phase 2: Duration of Response
Time frame: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
Phase 2: Disease Control Rate
Time frame: From date of randomization up to approximately 31 months
Phase 2: Overall Survival
Time frame: From date of randomization the date of death from any cause, up to approximately 31 months
Phase 2: Progression-Free Survival by Investigator
Time frame: From date of randomization to the date of radiographic disease progression, or death from any cause, whichever occurs first, up to approximately 31 months
Phase 1 and 2: Total and Unbound Plasma Concentration of Valemetostat
Time frame: Cycle 1: Day 1- Pre-dose, 2, 4, 5 hrs post-dose, Day 8- Pre-dose, Day 15- Pre-dose and post-dose. Cycles 2- 5: Day 1- Pre-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing valemetostat tosylate and pembrolizumab in people with Non-small Cell Lung Cancer and Lung Cancer, run by Daiichi Sankyo at 35 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, China, Argentina, Brazil, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b: Number of Participants with Dose-Limiting Toxicities (time frame: From day of first dose on Day 1 to Day 21 in Cycle 1 (21 days), or before the administration of Cycle 2, up to 24 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.