NCT04745988

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: National Cancer Center Hospital East · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-11
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2021-02-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Japan