NCT03421288

Study of Atezolizumab + FLOT vs. FLOT Alone in Patients With GC/GEJ and High Immune Responsiveness

A Randomized, Open-label Phase II/III Efficacy and Safety Study of Atezolizumab in Combination With FLOT Versus FLOT Alone in Patients With Gastric Cancer and Adenocarcinoma of the Oesophago-gastric Junction and High Immune Responsiveness (MO30039/MO43340) - The IKF-DANTE Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 677 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, controlled, open-label study comparing perioperative atezolizumab with FLOT chemotherapy versus FLOT alone in patients with locally advanced, operable adenocarcinoma of the stomach or GEJ with high immune responsiveness.

Detailed description

The study will evaluate the safety and efficacy of the study treatment regimens. Potential study participants will be assessed for eligibility during a 28-day screening period. Only immune-competent patients with either of the following MSI-high, PD-L1 CPS≥1, TMB ≥10/MB or EBV+ will be enrolled. Eligible patients will be randomized to perioperative treatment with either atezolizumab with FLOT (Arm A) or FLOT alone (Arm B). Randomization will occur in a 1:1 ratio with stratification by clinical nodal stage (N+ vs. N-), location of the primary (GEJ type I vs. GEJ type II/III vs. stomach), and PD-L1-combined positive score (CPS≥5 vs. CPS\<5) or MSI-status (MSI/MMRd vs. MSS/MMRp). Following randomization, study patients will enter the study treatment period which will last approximately 22 to 52 weeks depending on treatment arm and timing of surgery. Arm A: FLOT with Atezolizumab: Patients randomized to treatment Arm A will receive atezolizumab + FLOT in four 2-week treatment cycles as described below prior to undergoing surgery. Following surgery, patients will receive another four 2-week cycles of atezolizumab + FLOT followed by 8 additional 3-week treatment cycles with atezolizumab alone. Arm B: FLOT alone: Patients randomized to Arm B will receive FLOT alone for four 2-week treatment cycles prior to surgery. Following surgery, patients will receive another four 2-week cycles of chemotherapy alone.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	Day 1 q2w: 840 mg IV over 1 hour (4 cycles perioperative with FLOT) + Day 1 q3w: 1200 mg IV over 1 hour (8 additional cycles monotherapy)
DRUG	5-Fluorouracil	Day 1 q2w: 2600 mg/m² IV over 24 hours
DRUG	Calciumfolinat	Day 1 q2w: 200 mg/m² IV over 1 hour
DRUG	Oxaliplatin	Day 1 q2w: 85 mg/m² IV over 2 hours
DRUG	Docetaxel	Day 1 q2w: 50 mg/m² IV over 1 hour

Timeline

• Start date: 2018-09-14
• Primary completion: 2027-05-31
• Completion: 2027-12-31
• First posted: 2018-02-05
• Last updated: 2025-07-25

Locations

2 sites across 2 countries: Germany, Switzerland