An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the Neoadjuvant / Adjuvant Treatment for Patients With Gastric Cancer

April 6, 2026 updated by: Kohei Shitara, National Cancer Center Hospital East
This study is an open label phase 2 study to evaluate the safety and efficacy of Lenvatinib with Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the neoadjuvant / adjuvant treatment for Patients with Gastric Cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is an open-label, single-arm, single-center, phase 2 clinical trial. Eligible patients are with previously untreated gastric and gastroesophageal junction adenocarcinoma as defined by cT2-4 and/or cN+ without evidence of metastatic disease. Patients in the exploratory cohort will receive 3 cycles of 20 mg oral Lenvatinib daily plus 200 mg intravenous Pembrolizumab every 3 weeks as the neoadjuvant treatment followed by surgery, and then 3 cycles of Lenvatinib plus Pembrolizumab followed by 11 cycles of Pembrolizumab monotherapy as the adjuvant treatment. Also, Patients in the FLOT cohort will receive 3 cycles of 8 mg oral Lenvatinib daily, 200 mg intravenous Pembrolizumab every 3 weeks and FLOT (Docetaxel 50 mg/m2, Oxaloplatin 85 mg/m2, Levofolinate 200 mg/m2, 5-FU 2600 mg/m2) every 2 weeks as the neoadjuvant treatment followed by surgery, and then 3 cycles of Lenvatinib ,Pembrolizumab plus FLOT followed by 11 cycles of Pembrolizumab monotherapy as the adjuvant treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan
        • National Cancer Center Hospital East

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Have gastric and gastroesophageal junction adenocarcinoma
  2. Untreated and cT2-4 and/or cN+ without evidence of metastatic disease
  3. Patients at least 20 years of age on the day of providing consent.
  4. Patients with a performance status of 0 or 1 on the Eastern Cooperative Oncology Group.

  5. Patients with adequate organ function at the time of enrollment as defined below:

    • Neutrophil count ≥1500mm3
    • Platelet count ≥10 × 100,000/mm3
    • Hemoglobin (Hb) ≥ 9.0 g/dL,
    • Total bilirubin ≤1.5 mg/dL
    • AST (GOT) and ALT (GPT) ≤ 100 IU/L
    • Creatinine ≤1.5 mg/dL
    • Urinary protein : It satisfies one of the following (if any of the inspection criteria are satisfied, other examination may not be carried out) (i) urinary protein (test paper method) is 2+ or less (ii) Urine Protein Creatinine (UPC) ratio <3.5 (iii) 24-hour urine protein was measured, urinary protein ≦ 3500 mg
    • International normalized ratio (INR) ≤ 1.5
  6. Patients who not received a blood transfusion within 14 days of registration.
  7. Patients have recovered adverse events associated with radiation and surgical operation as pretreatment to Grade 1 or less or baseline or less with CTCAE v5.0 excluding stable symptoms. However, adverse events with stable symptoms even with Grade 2 or higher excluded.
  8. Female of childbearing potential who are negative in a pregnancy test within 14 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence or use of a male condom plus partner use of contraceptive method [an intrauterine device or hormone releasing system, a contraceptive implant and an oral contraceptive]) starting with the first dose of study therapy through 120 days after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment.
  9. Patients capable of taking oral medication.
  10. Patients who provided written informed consent to be subjects in this study.

Exclusion Criteria:

  1. Patients who have undergone surgical treatment and radiotherapy within 2 weeks before enrollment.
  2. Patients with hypertension that is difficult to control (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents.
  3. Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollment.
  4. Patients with a history of New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction.
  5. Patients have an addigional active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months.
  6. Patients have severe (hospitalization required) complications (intenstinal palsy, intestinal obstruction, pulmonary fibrosis, diabetes difficult to control, heart failure, myocardial infarction, unstable angina, renal failure, liver failure, mental disease, cerebrovascular disease etc).
  7. Patients with a history of a gastrointestinal perforation and /or gastrointestinal fistula within 6 months before enrollment.
  8. Is infected with active hepatitis B (defined as HBs antigen positive) or hepatitis C.
  9. Patients with a history of human immunodeficiency virus (HIV).
  10. Patients with a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  11. Patients who are administered live vaccines <30 days before the initiation of treatment with the investigational drug.
  12. Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease.
  13. Patients who require systemic corticosteroids (excluding temporary usage for tests, prophylactic administration for allergic reactions, or to alleviate swelling associated with radiotherapy) or immunosuppressants, or who have received such a therapy <14 days before enrollment.
  14. Patients have serious non-healing wound, ulcer, or bone fracture.
  15. Females who are pregnant or breastfeeding.
  16. Patients have no intention to comply with the protocol or cannot comply.
  17. Patients were judged unsuitable as subject of this study by investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lenvatinib Plus Pembrolizumab
One cycle is 21 days, with Lenvatinib plus Pembrolizumab repeated 3 cycles before surgery and 3 cycles after surgery, followed by 11 cycles of pembrolizumab monotherapy as the adjuvant treatment.
Drug: Lenvatinib 20mg
Lenvatinib will be administered at a dose of 20mg as oral dose, once a day.
Drug: Pembrolizumab
Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).
Experimental: Lenvatinib, Pembrolizumab Plus FLOT
One cycle is 21 days, with Lenvatinib, Pembrolizumab plus FLOT repeated 3 cycles before surgery and 3 cycles after surgery, followed by 11 cycles of pembrolizumab monotherapy as the adjuvant treatment.
Drug: Pembrolizumab
Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).
Drug: Lenvatinib 8mg
Lenvatinib will be administered at a dose of 8mg as oral dose, once a day.
Drug: Docetaxel
Docetaxel will be administered at a dose of 50mg/m^2 as a IV infusion, Q2W.
Drug: Oxaliplatin
Oxaliplatin will be administered at a dose of 85mg/m^2 as a IV infusion, Q2W.
Drug: Levofolinate
Levofolinate will be administered at a dose of 200mg/m^2 as a IV infusion, Q2W.
Drug: Fluorouracil
Levofolinate will be administered at a dose of 2600mg/m^2 as a IV infusion, Q2W.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major pathological response (MPR) rate
Time Frame: 6 months
The MPR rate will be defined as the proportion of patients whose percentage of residual tumor in the stomach and lymph node decreased to < 10%, as determined by a pathologist.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR) rate
Time Frame: 6 months
The pCR rate will be defined as the proportion of patients whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
6 months
Tumor response in the gastric primary lesion
Time Frame: 6 months
The number of patients achieving endoscopic CR, PR, SD, or PD will be separately tabulated.
6 months
Radical resection rate
Time Frame: 6 months
The radical resection rate will be defined as the proportion of patients who underwent a radical resection (R0 resection).
6 months
Treatment completion rate until surgery
Time Frame: 6 months
The treatment completion rate will be defined as the proportion of patients who started the protocol treatment, completed a three-cycle treatment with the study drug, and then underwent a radical resection (R0 resection).
6 months
Treatment completion rate until adjuvant treatment
Time Frame: 1 year 8 months
The treatment completion rate will be defined as the proportion of patients who started the protocol treatment, completed a three-cycle treatment with the study drug, and then underwent a radical resection (R0 resection) and adjuvant treatment was performed up to 14 cycles.
1 year 8 months
Event free survival (EFS)
Time Frame: 3 years

The registration date is the starting date, and is defined as the period until the event that occurs any of the following.

  • Disease progression based on image evaluation using RECIST 1.1
  • Recurrence based on CT or biopsy among patients with no postoperative lesions
  • Death of any cause If it is determined to be exacerbated based on the image evaluation, the inspection date on which the image inspection was performed shall be the exacerbation date.

Secondary primary malignancies are not an EFS event. Patients for whom no EFS event has been recorded will be censored on the final image evaluation date.
3 years
Overall survival (OS)
Time Frame: 3 years

The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause.

Surviving patients should be censored on the last day of PFS confirmed (Confirmation of survival by telephone inquiry will be acceptable. However, the fact of confirming survival should be documented in medical records.).

Patients who are lost to follow up should be censored on the last day when their survival is confirmed before being lost to follow up.
3 years
The incidence of adverse events
Time Frame: Up to 30 days after the last dose
For adverse events due to protocol treatment, determine the frequency of worst grades in all courses according to CTCAE v5.0, the incidence of adverse events of Grade 3 or higher, and the incidence of adverse events of Grade 4 or higher.
Up to 30 days after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Center Hospital East

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPOC2001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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