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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

NCT04745988 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

Interventions

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).

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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-11
Primary Completion
2026-08-31
Completion
2027-08-31

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04745988 on ClinicalTrials.gov