18 and older, any sex, with Gastroesophageal Junction Adenocarcinoma or Gastric 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 the Date of the First Radiographically Documented Progressive Disease or Death from Any Cause (Up To 30 Months)
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, rega
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
4.14
3.71 – 4.30
Placebo + 80 mg/m² Paclitaxel
3.15
2.83 – 4.14
Overall Survival (OS)Primary· Randomization to Date of Death from Any Cause (Up To 37 Months)
OS defined as the time from randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
8.71
7.98 – 9.49
Placebo + 80 mg/m² Paclitaxel
7.92
6.31 – 9.10
Time to Progression (TTP)Secondary· Randomization to the Date of the First Radiographically Documented Progressive Disease (Up To 30 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
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
4.27
4.14 – 5.52
Placebo + 80 mg/m² Paclitaxel
4.07
2.92 – 4.17
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])Secondary· Randomization to Objective Disease Progression (Up To 30 Months)
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with refer
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
26.5
21.6 – 32.0
Placebo + 80 mg/m² Paclitaxel
21.9
15.5 – 29.5
Duration of Objective Response (DoR)Secondary· Date of Objective Response to the Date of the First Radiographically Documented Progressive Disease or Death Due to Any Cause (Up To 24 Months)
DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
4.34
3.12 – 5.22
Placebo + 80 mg/m² Paclitaxel
2.83
2.56 – 4.14
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)Secondary· Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status, 5 functional domains (physical, role, cognitive, emotional, and social) and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 100 with higher scores representing a better level of functioning. Fo
Global health status
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
5.30
± 1.18
Placebo + 80 mg/m² Paclitaxel
8.43
± 1.56
Functional scale: Physical functioning
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
1.09
± 0.82
Placebo + 80 mg/m² Paclitaxel
1.20
± 1.10
Functional scale: Role functioning
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
0.60
± 1.13
Placebo + 80 mg/m² Paclitaxel
1.27
± 1.49
Functional scale: Emotional functioning
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
5.89
± 0.90
Placebo + 80 mg/m² Paclitaxel
4.72
± 1.19
Functional scale: Cognitive functioning
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
2.87
± 0.84
Placebo + 80 mg/m² Paclitaxel
2.12
± 1.11
Functional scale: Social functioning
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
2.71
± 1.19
Placebo + 80 mg/m² Paclitaxel
2.98
± 1.59
Symptom scale: Fatigue
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
-4.20
± 1.14
Placebo + 80 mg/m² Paclitaxel
-5.63
± 1.51
Symptom scale: Nausea and vomiting
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
-4.84
± 0.77
Placebo + 80 mg/m² Paclitaxel
-3.80
± 1.03
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)Secondary· Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status, 5 functional domains (physical, role, cognitive, emotional, and social) and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 100 with higher scores representing a better level of functioning. Fo
Global health status
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
-14.42
± 1.32
Placebo + 80 mg/m² Paclitaxel
-9.83
± 1.75
Functional scale: Physical functioning
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
-14.31
± 1.30
Placebo + 80 mg/m² Paclitaxel
-11.71
± 1.73
Functional scale: Role functioning
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
-18.46
± 1.72
Placebo + 80 mg/m² Paclitaxel
-14.39
± 2.28
Functional scale: Emotional functioning
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
-9.80
± 1.30
Placebo + 80 mg/m² Paclitaxel
-6.77
± 1.72
Functional scale: Cognitive functioning
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
-13.66
± 1.40
Placebo + 80 mg/m² Paclitaxel
-12.08
± 1.85
Functional scale: Social functioning
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
-17.05
± 1.73
Placebo + 80 mg/m² Paclitaxel
-16.52
± 2.30
Symptom scale: Fatigue
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
15.28
± 1.36
Placebo + 80 mg/m² Paclitaxel
10.17
± 1.80
Symptom scale: Nausea and vomiting
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
8.57
± 1.46
Placebo + 80 mg/m² Paclitaxel
8.66
± 1.95
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index ScoreSecondary· Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
-0.1351
± 0.2472
Placebo + 80 mg/m² Paclitaxel
-0.1303
± 0.1765
Change From Baseline in Participant-Reported EQ-5D-3L Visual Analog Scale (VAS) ScoreSecondary· Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. The EQ-5D VAS is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).
Group
Value
95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
-9.6
± 20.11
Placebo + 80 mg/m² Paclitaxel
-8.6
± 15.88
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events: Randomization Up To 26 Months; All-Cause Mortality: Randomization to Date of Death from Any Cause (Up To 37 Months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Other recruiting trials for Gastroesophageal Junction Adenocarcinoma
Currently open trials in the same condition.
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· recruiting
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· recruiting
NCT07182565 — Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcin
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· recruiting
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· recruiting
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· Phase 1, PHASE2
· recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
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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: 14 June 2022
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/NCT02898077.