Histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition). MedDRA version: 21.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10066354 Term: Adenocarcinoma of the gastroesophageal junction System Organ Class: 10029104 - Neoplasms benign, malignant
Conditions
Interventions
Product Name: Durvalumab
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: durvalumab
CAS Number: 1428935-60-7
Current Sponsor code: MEDI4736
Conce
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition). Patients must have undergo radical surgery. No prior anti-cancer therapy for the current malignancy. World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment Adequate organ and marrow function Availability of tumor sample prior to study entry Must have a life expectancy of at least 24 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 450
Exclusion criteria
Exclusion criteria: Patients with peritoneal dissemination or distant metastasis Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor History of allogeneic organ transplantation. Contra-indication to any of the study drugs Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare Arm A relative to Arm B on event-free survival (EFS);Secondary Objective: To compare Arm A relative to Arm B on overall survival (OS) To compare Arm A relative to Arm B on pathological complete response (pCR) rate To compare Arm A relative to Arm B on the proportion of patients who undergo gastrectomy or gastrophagectomy To compare Arm A relative to Arm B on the rate of complete resection (R0) To compare Arm A relative to Arm B on metastasis-free survival (MFS) and disease-specific survival (DSS) To compare Arm A relative to Arm B on disease-free survival in patients who undergo R0 resection surgery To compare Arm A relative to Arm B on EFS24, EFS36, OS24, OS36, DFS24, and DFS36 To compare Arm A relative to Arm B on efficacy endpoints by PD-L1 expression To compare Arm A relative to Arm B on disease-related symptoms, impacts, and HRQoL To evaluate PK of Arm A and Arm B To assess the immunogenicity of Arm A and Arm B;Primary end point(s): EFS (event free survival);Timepoint(s) of evaluation of this end point: EFS will be analyzed at the end of the study using a stratified log-rank test adjusting for the stratification factors of geographic region, clinical lymph node status, and PD-L1 expression status. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): OS, pCR rate Surgery rate R0 resection rate MFS, DSS, DFS EFS24, EFS36, OS24, OS36,DFS24, DFS36 EORTC QLQ-C30, QLQ-STO22, and IL38;Timepoint(s) of evaluation of this end point: The primary and key secondary endpoints will be evaluated at an interim analysis and all endpoints will be evaluated at the final analysis. | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Hungary, Japan, Korea, Democratic People's Republic of, Netherlands, Peru, Poland, Russian Federation, Spain, Taiwan, Türkiye, United Kingdom, United States
Contacts
Public ContactStudy Information Center
AstraZeneca Clinical
Outcome results
None listed