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Gastric CancerPhase 2NCT04745988

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

A Phase 2 study testing Lenvatinib 20mg, Pembrolizumab and Lenvatinib 8mg in people with Gastric Cancer, run by National Cancer Center Hospital East at 1 site in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Lenvatinib 20mg, Pembrolizumab and Lenvatinib 8mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteJapan
Study dates
11 Nov 2021to Aug 2027
Phase
Phase 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have gastric and gastroesophageal junction adenocarcinoma
  • Untreated and cT2-4 and/or cN+ without evidence of metastatic disease
  • Patients at least 20 years of age on the day of providing consent.
  • Patients with a performance status of 0 or 1 on the Eastern Cooperative Oncology Group.
  • Patients with adequate organ function at the time of enrollment as defined below:
  • Neutrophil count ≥1500mm3
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  • 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
  • Patients who not received a blood transfusion within 14 days of registration.
  • 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.
  • 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.
  • Patients capable of taking oral medication.
  • Patients who provided written informed consent to be subjects in this study.

Who cannot join

  • Patients who have undergone surgical treatment and radiotherapy within 2 weeks before enrollment.
  • 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.
  • 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.
  • Patients with a history of New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction.
  • 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.
  • 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).
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  • Patients with a history of a gastrointestinal perforation and /or gastrointestinal fistula within 6 months before enrollment.
  • Is infected with active hepatitis B (defined as HBs antigen positive) or hepatitis C.
  • Patients with a history of human immunodeficiency virus (HIV).
  • Patients with a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Patients who are administered live vaccines <30 days before the initiation of treatment with the investigational drug.
  • Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease.
  • 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.
  • Patients have serious non-healing wound, ulcer, or bone fracture.
  • Females who are pregnant or breastfeeding.
  • Patients have no intention to comply with the protocol or cannot comply.
  • Patients were judged unsuitable as subject of this study by investigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • National Cancer Center Hospital East

    Kashiwa, Chiba

Other trials in Japan

About this study

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.

Read the 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.

Conditions
Gastric Cancer
Being tested
Lenvatinib 20mg, Pembrolizumab, Lenvatinib 8mg, Docetaxel, Oxaliplatin
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lenvatinib 20mgDrug

    Lenvatinib will be administered at a dose of 20mg as oral dose, once a day.

  • PembrolizumabDrug

    Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).

  • Lenvatinib 8mgDrug

    Lenvatinib will be administered at a dose of 8mg as oral dose, once a day.

  • DocetaxelDrug

    Docetaxel will be administered at a dose of 50mg/m^2 as a IV infusion, Q2W.

  • OxaliplatinDrug

    Oxaliplatin will be administered at a dose of 85mg/m^2 as a IV infusion, Q2W.

  • LevofolinateDrug

    Levofolinate will be administered at a dose of 200mg/m^2 as a IV infusion, Q2W.

  • FluorouracilDrug

    Levofolinate will be administered at a dose of 2600mg/m^2 as a IV infusion, Q2W.

Study groups in NCT04745988
Study groupRoleWhat they receive
Lenvatinib Plus PembrolizumabExperimentalOne 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.
Receives: Drug: Lenvatinib 20mg; Drug: Pembrolizumab
Lenvatinib, Pembrolizumab Plus FLOTExperimentalOne 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.
Receives: Drug: Pembrolizumab; Drug: Lenvatinib 8mg; Drug: Docetaxel; Drug: Oxaliplatin; Drug: Levofolinate; Drug: Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major pathological response (MPR) rate

    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.

    Measured: 6 months

Secondary outcomes (8)

  1. Pathological complete response (pCR) rate

    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.

    Measured: 6 months

  2. Tumor response in the gastric primary lesion

    The number of patients achieving endoscopic CR, PR, SD, or PD will be separately tabulated.

    Measured: 6 months

  3. Radical resection rate

    The radical resection rate will be defined as the proportion of patients who underwent a radical resection (R0 resection).

    Measured: 6 months

  4. Treatment completion rate until surgery

    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).

    Measured: 6 months

  5. Treatment completion rate until adjuvant treatment

    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.

    Measured: 1 year 8 months

  6. Event free survival (EFS)

    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.

    Measured: 3 years

  7. Overall survival (OS)

    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.

    Measured: 3 years

  8. The incidence of adverse events

    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.

    Measured: Up to 30 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2021
  2. Study start11 Nov 2021
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04745988
Sponsor's protocol ID
EPOC2001
Status last verified
Apr 2026
First submitted
8 Feb 2021
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib 20mg, Pembrolizumab and Lenvatinib 8mg in people with Gastric Cancer, run by National Cancer Center Hospital East at 1 site in Japan.

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 18 inclusion and 17 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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 phase mean?

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?

Major pathological response (MPR) rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04745988.

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 9 Apr 2026.

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