NCT04933227

A Study to Explore the Efficacy and Safety of Atezolizumab Plus Tiragolumab and Chemotherapy in 1st Line HER2 Negative Unresectable, Recurrent or Metastatic Gastric Cancer or Adenocarcinoma of Gastroesophageal Junction (GEJ)

A Phase II, Single-Arm Study to Explore the Efficacy and Safety of Atezolizumab Plus Tiragolumab and Chemotherapy in 1st Line HER2 Negative Unresectable, Recurrent or Metastatic Gastric Cancer or Adenocarcinoma of Gastroesophageal Junction (GEJ)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with capecitabine plus oxaliplatin (XELOX) for first-line treatment in participants with HER2-negative unresectable advanced, recurrent or metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ AC).

Conditions

• Stomach Neoplasms
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab 1200 mg will be administered intravenously (IV) on Day 1 of each 21-day cycle.
DRUG	Tiragolumab	Tiragolumab 600 mg will be administered IV on Day 1 of each 21-day cycle.
DRUG	Oxaliplatin	Oxaliplatin 130 mg/m\^2 will be administered IV on Day 1 of each 21-day cycle during Cycles 1-4.
DRUG	Capecitabine	Capecitabine 1000 mg/m\^2/d will be administered orally (PO) twice daily (bid) on Days 1-14 during Cycles 1-4.

Timeline

• Start date: 2021-08-06
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2021-06-21
• Last updated: 2024-11-14

Locations

11 sites across 1 country: China

Regulatory

• FDA-regulated drug study