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Official websites use. Share sensitive information only on official, secure websites. Published Online: April 4, JAMA Oncology. Author Contributions: Drs Tougeron and Le Malicot had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr Aparicio reported nonfinancial support from MSD and personal fees from BMS during the conduct of the study; personal fees from Pierre fabre outside the submitted work.
No other disclosures were reported. AstraZeneca provided financial support for the trial. FFCD funded the biobank and molecular analyses. AstraZeneca provided the study drug. AstraZeneca had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
Data Sharing Statement: See Supplement 5. We thank AstraZeneca for providing durvalumab and tremelimumab. Finally, we thank the Ligue nationale contre le cancer for their support. However, the primary end point, progression-free survival at 4 months, was not met despite a subgroup of patients with durable disease control.
Efficacy of second-line chemotherapy in advanced gastric or gastrooesphageal junction GEJ adenocarcinoma remains limited. The efficacy analyses used a clinical cutoff date of January 9, Overall, between August 27, , and June 4, , 96 patients were randomized 48 in each arm. The median age was Four month PFS was The primary end point was not met.
Median PFS was 3. Disease control beyond 1 year was Grade 3 to 4 treatment-related adverse events were observed in 22 The trial protocol is in Supplement 1 and the statistical analysis plan is in Supplement 2.