18 and older, any sex, with Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS)Primary· Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months)
PFS time was measured from the date of randomization to the date of radiographic(rgr) documentation of progression(by RECIST v.1.1) or the date of death due to any cause, whichever was earlier.If a participant did not have a complete baseline tumor assessment,then the PFS time was censored at the randomization date.If a participant was not known to have died or have rgr documented progression as of the data cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. If death or progressive disease(PD) occurred after 2 or more consecutive missing rgr visi
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
5.72
5.45 – 6.51
Placebo + Cisplatin + Capecitabine
5.39
4.47 – 5.72
Overall Survival (OS)Secondary· Randomization to Death from Any Cause (Up To 30 Months)
OS was time from the date of randomization to the date of death from any cause. If the participant was alive at the cutoff for analysis (or was lost to follow-up), OS data were censored for analysis on the last date the participant was known to be alive.
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
11.17
9.92 – 11.93
Placebo + Cisplatin + Capecitabine
10.74
9.53 – 11.89
Progression- Free Survival 2 (PFS2)Secondary· Randomization to Second Radiological or Symptomatic Disease Progression After the Start of Additional Systemic Anticancer Treatment or Death from Any Cause (Up To 26 Months)
PFS2 was defined as the time from the date of randomization to second disease progression (defined as objective radiological or symptomatic progression), or death of any cause, whichever occurs first. Participants alive and for whom a second disease progression has not been observed (including participants who did not receive any additional systemic anticancer treatments) were censored at the last time known to be alive and without second disease progression. The second progression refers to disease progression on or after additional systemic anticancer therapy, regardless if any earlier progr
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
10.18
9.03 – 10.84
Placebo + Cisplatin + Capecitabine
9.20
8.34 – 9.99
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])Secondary· Randomization to Disease Progression (Up To 26 Months)
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1).Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
41.1
35.8 – 46.4
Placebo + Cisplatin + Capecitabine
36.4
31.1 – 41.6
Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])Secondary· Randomization to Disease Progression (Up To 26 Months)
DCR was the percentage of participants with a best overall response of CR, PR, or SD as per Response using RECIST v1.1 criteria. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Stable Disease: Neither sufficient shrin
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
81.9
77.7 – 86.1
Placebo + Cisplatin + Capecitabine
76.5
71.8 – 81.1
Time to Progression (TTP)Secondary· Randomization to Disease Progression (Up To 24 Months)
TTP was time from the date of randomization to the date of radiographic progression (according to RECIST v.1.1). If a participant died due to any reason without radiographic progression, TTP is censored at the last adequate tumor assessment. Target lesions: Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions: PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
6.77
5.88 – 7.66
Placebo + Cisplatin + Capecitabine
5.78
5.55 – 6.37
Duration of Response (DoR)Secondary· Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
Participants achieved an objective response if they had a best overall response of CR or PR.Target lesions- CR:Disappearance of all lesions;any pathological lymph nodes must have reduction in short axis to \<10 mm.PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum.PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s).Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels;all lymph
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
5.72
5.09 – 6.34
Placebo + Cisplatin + Capecitabine
4.27
3.88 – 4.90
Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL ScaleSecondary· Randomization, First worsening in QoL (Up To 26 Months)
Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment.
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
9.00
8.08 – 12.58
Placebo + Cisplatin + Capecitabine
9.46
6.74 – 11.99
Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L)Secondary· Randomization, 30 Days After Treatment Discontinuation (Up To 5 Months)
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
EQ-5D index
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
-0.008
± 0.148
Placebo + Cisplatin + Capecitabine
-0.010
± 0.157
EQ-5D VAS
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
0.8
± 18.56
Placebo + Cisplatin + Capecitabine
1.5
± 20.33
Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)Secondary· Randomization to ECOG PS ≥2 (Up To 26 Months)
The time from the date of randomization to the first date observing ECOG PS ≥2 (that is, deterioration from baseline status of 0 or 1). Participants without PS deterioration were censored at their last documented assessments of 0 or 1. ECOG Performance Status: 2- Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3 -Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 -Completely disabled. Cannot carry on any selfcare.Totally confined to bed or chair,5- Dead.
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
NA
12.2 – NA
Placebo + Cisplatin + Capecitabine
NA
NA – NA
Number of Participants With Anti-Ramucirumab AntibodiesSecondary· Predose Cycle 1 through 30 Days After Treatment Discontinuation (Up To 24 Months)
Participants who developed treatment-emergent antibody responses to Ramucirumab postbaseline.
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
4
Placebo + Cisplatin + Capecitabine
5
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of RamucirumabSecondary· Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI
Pharmacokinetics (PK): Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab
Cycle 1, Day 1
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
133
± 31
Cycle 3, Day 1
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
173
± 35
Cycle 9, Day 1
Group
Value
95% CI
Ramucirumab + Cisplatin + Capecitabine
169
± 60
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline Up To 5.6 Years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
NCT06675136 — Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal
· Phase 1
· recruiting
NCT07098338 — A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
· Phase 2
· recruiting
NCT06616584 — Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had
· Phase 2, PHASE3
· recruiting
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· Phase 1, PHASE2
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 26 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02314117.