NCT04745988View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

November 11, 2021

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2027

Conditions
Gastric Cancer
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.

Trial Locations (1)

Unknown

National Cancer Center Hospital East, Kashiwa

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

National Cancer Center Hospital East

OTHER