| Primary | Percentage of Participants With Objective Response Assessed by Independent Review Committee | Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to PD or death due to any cause (up to approximately 3 years) | | | | ID | Title | Description |
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| OG000 | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day. | | OG001 | ECX Only | Participants received epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00031(17 to 49)
- OG00158(41 to 74)
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| Secondary | Duration of Objective Response Assessed by Independent Review Committee | Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (PD: >25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis. | | Posted | | Median | 95% Confidence Interval | months | | From first documented objective response to PD or death due to any cause (up to approximately 3 years) | | | | ID | Title | Description |
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| OG000 | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day. | | OG001 | ECX Only | Participants received epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn. |
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| Secondary | Progression-Free Survival | PFS was defined as the time from randomization to the first documentation of PD or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis. | | Posted | | Median | 95% Confidence Interval | months | | Baseline up to PD or death due to any cause (up to approximately 3 years) | | | | ID | Title | Description |
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| OG000 | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day. | | OG001 | ECX Only | Participants received epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn. |
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| Secondary | Overall Survival (OS) | OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis. | | Posted | | Median | 95% Confidence Interval | months | | Baseline until death due to any cause (up to approximately 3 years) | | | | ID | Title | Description |
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| OG000 | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day. | | OG001 | ECX Only | Participants received epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn. |
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| Secondary | Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score | EORTC QLQ-C30 included GHS/QoL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from EORTC QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL was linearly transformed and ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). EORTC QLQ-C30 GHS/QoL score at baseline and best overall change from baseline (throughout study) are reported. | ITT population. Here, overall number of participants analyzed = participants who were evaluable for this outcome and "Number analyzed" = participants evaluable for specified timepoint for each arm, respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day 1), Post Baseline (Up to 3 Years) | | | | ID | Title | Description |
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| OG000 | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day. |
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| Secondary | Protein Biomarkers Levels | | Data for this outcome was not collected from any of the participant; hence, no data available for reporting. | Posted | | | | | | Baseline up to approximately 3 years | | | | ID | Title | Description |
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| OG000 | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day. | | OG001 | ECX Only | Participants received epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn. |
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| Secondary | Percentage of Participants With Anti-Matuzumab Antibodies | | Data for this outcome was not collected from any of the participant; hence, no data available for reporting. | Posted | | | | | | Baseline up to approximately 3 years | | | | ID | Title | Description |
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| OG000 | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day. | | OG001 | ECX Only | Participants received epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn. |
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| Secondary | Matuzumab Serum Concentration | | Data for this outcome was not collected from any of the participant; hence, no data available for reporting. | Posted | | | | | | Baseline up to approximately 3 years | | | | ID | Title | Description |
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| OG000 | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | Participants received matuzumab 800 mg IV every week and epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered and after 8 cycles, matuzumab alone was continued until PD, unacceptable toxicity, death, or consent was withdrawn. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of epirubicin administration when these treatments were given on the same day. | | OG001 | ECX Only | Participants received epirubicin 50 mg/m^2, cisplatin 60 mg/m^2 on Day 1 and capecitabine 1250 mg/m^2 daily in a 21-day cycles (ECX). A maximum of 8 cycles of ECX were administered unless there was evidence of PD, or unacceptable toxicity, death occurred or consent was withdrawn. |
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