Zolbetuximab Plus mFOLFOX6 Trial Overview

What was the planned event for the final analysis of progression-free survival?

What was the assumed median progression-free survival for zolbetuximab plus mFOLFOX6 compared to placebo?

What significance level was used for the progression-free survival analysis?

What was the dropout rate considered for the sample size calculation?

How did the number of adverse events compare between the two treatment groups?

What is the hazard ratio (HR) indicating the reduction in the risk of death for zolbetuximab treatment compared to placebo?

What percentage of patients in the zolbetuximab group experienced grade 3 or worse adverse events?

Name two of the most common all-grade adverse events associated with zolbetuximab treatment.

How many treatment-related deaths occurred in the zolbetuximab group?

What does CLDN18.2-targeting with zolbetuximab lead to in terms of patient outcomes?

In which type of cancer might zolbetuximab plus mFOLFOX6 be considered a new first-line treatment?

What is the significance of the confidence interval (CI) provided with the hazard ratio?

What was the effect of combining zolbetuximab with mFOLFOX6 compared to placebo?

What were the primary and key secondary endpoints assessed in the study?

How frequently were health-related quality-of-life assessments conducted during the study?

What criteria were used to assess adverse events in the trial?

What does RECIST version 1.1 stand for and why is it important in this study?

What type of outcomes were included as additional patient-reported measures in the study?

Who determined the progression-free survival per RECIST version 1.1 in the trial?

What was the timeline for monitoring adverse events after treatment discontinuation?

In what context was the objective response assessed in this study?

What was the primary registration number for the study?

What percentage of patients screened for the study were at the stomach primary site?

What was the role of the funding source in the study?

What type of Lauren classification reported the highest percentage in the results?

How many patients were screened in total between June 21, 2018, and April 1, 2022?

What was the total duration of the study period mentioned?

What percentage of patients were Hispanic or Latino?

In the context of the study, what does the 'safety analysis set' consist of?

How many patients had metastases located in the liver?

What tools were used for sample size calculations and statistical analyses in the study?

What was the proportion of patients with a previous gastrectomy?

What age group (in terms of tumor burden) was represented by 77% and 78% in terms of progression-free survival?

How did the percentage of patients in the 'not Hispanic or Latino' category compare between the two groups?

What was the placebo group's median progression-free survival compared to the zolbetuximab group?

What was the rate of treatment-emergent grade 3 or worse adverse events in the zolbetuximab group?

How did nausea and vomiting impact patient participation in the study?

Which demographic group showed a higher incidence of adverse events in the zolbetuximab group?

What was the difference in adverse events between the Asia and non-Asia regions in the context of zolbetuximab patients?

How did the previous gastrectomy status affect adverse event rates in the zolbetuximab group?

What was the percentage of patients experiencing adverse events related to the primary site of stomach cancer in the zolbetuximab group?

What effect did the number of metastatic sites have on adverse events in zolbetuximab-treated patients?

How did the race of patients correlate with adverse events in the zolbetuximab treatment group?

What was the impact of a tobacco history on adverse event rates in the zolbetuximab group?

In terms of overall survival, which treatment group appeared more favorable based on the Kaplan-Meier plot?

What was the effect of combining zolbetuximab with mFOLFOX6 based on the observed data?

What was the rate of discontinuation due to treatment-related deaths in the zolbetuximab group?

What method was used for randomising patients in the SPOTLIGHT trial?

What specific patient population was targeted in the SPOTLIGHT trial?

How was treatment masking maintained for both zolbetuximab and placebo?

What was the dosage regimen for zolbetuximab in the SPOTLIGHT trial?

What aspect of the trials was emphasized by stratification in the randomisation process?

Why is the conduct of the SPOTLIGHT trial significant in the context of gastric cancer treatment?

What regulatory standards were adhered to during the SPOTLIGHT trial?

In the context of the SPOTLIGHT trial, what does the term 'double-blind' refer to?

What types of cancer are included in the context of unmet medical needs mentioned in the article?

What is the standard first-line chemotherapy regimen for patients with locally advanced unresectable or metastatic gastric cancer?

What role does trastuzumab play in the treatment of gastric cancer according to the document?

What significant challenge is highlighted for patients with HER2-negative gastric cancer?

What type of therapy was specifically not approved for first-line treatment of HER2-negative gastric cancer at the time of the study?

What is the significance of the programmed death-ligand 1 (PD-L1) combined positive score (CPS) of 5 or more?

Which two treatment modalities are mentioned as being combined in the context of the study?

What overall survival benefit does the combination of zolbetuximab and mFOLFOX6 aim to provide?

What outcome does CLDN18.2-targeting with zolbetuximab lead to, as suggested in the research context?

How does the study highlight the geographic disparity in gastric cancer treatment needs?

What percentage of tumor cells must show moderate-to-strong membranous CLDN18 staining to consider a patient CLDN18.2-positive?

In the study design, how many 42-day cycles were patients treated with mFOLFOX6 or placebo?

What method was used to assess the radiological tumor response during the trial?

What was the Eastern Cooperative Oncology Group's role in this study?

What were the two types of levofolinate doses referenced in the protocol?

What was a significant outcome observed when combining CLDN18.2-targeted therapy with standard chemotherapy in the SPOTLIGHT study?

What constitutes a patient's inclusion criteria related to tumor characterization in this study?

What methodology was used to filter relevant studies in the SPOTLIGHT research?

What was the main adverse effect associated with zolbetuximab that led to treatment discontinuation?

Until what point could treatment continue in patients without disease progression?

What assay was utilized to determine CLDN18.2 positivity in patients?

How did the safety profile of zolbetuximab compare to that of placebo when added to chemotherapy?

What percentage of screened patients had tumors that qualified as CLDN18.2 positive in the study?

What is the primary focus of the SPOTLIGHT study in terms of cancer type?

Which phase of clinical trials did the studies evaluated in the SPOTLIGHT research primarily belong to?

What was the role of the monitoring process concerning adverse events after treatment discontinuation?

What was the hazard ratio (HR) boundary set for the progression-free survival analysis in the study?

At what point was overall survival tested according to the study design?

What was the one-sided type I error rate threshold maintained in the study?

What conditions led to patients being excluded from the efficacy analysis despite having CLDN18.2-positive tumors?

How many deaths were planned for the final analysis of overall survival?

What was the significance of the interim analysis planned in the study design?

How were the reasons for discontinuation characterized in the trial?

What was the purpose of conducting health-related quality-of-life assessments during the study?

How might the distribution of patients from Japan and Korea influence the findings in the SPOTLIGHT study?

What impact did the longer-than-expected placebo group's overall survival have on the interpretation of progression-free survival in other studies?

In the context of the studies mentioned, why is it important to analyze subgroup differences in treatment outcomes?

What does a median progression-free survival of less than 3 months imply in the context of statistical assumptions for clinical trials?

How does the follow-up of patients in ongoing trials like GLOW contribute to the understanding of treatment effects over time?