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NCT02898077

A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer

Completed Phase 3 Results posted Last updated 14 June 2022
What this trial tests

Phase 3 trial testing Ramucirumab in Gastroesophageal Junction Adenocarcinoma in 440 participants. Completed in 12 April 2021.

Timeline
2 March 2017
Primary endpoint
30 June 2020
12 April 2021

Quick facts

Lead sponsorEli Lilly and Company
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment440
Start date2 March 2017
Primary completion30 June 2020
Estimated completion12 April 2021
Sites32 locations across China, Philippines, Thailand, Malaysia

Drugs / interventions tested

Conditions studied

Sponsor

Eli Lilly and Company — full company profile →

Who can join

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

GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel4.143.71 – 4.30
Placebo + 80 mg/m² Paclitaxel3.152.83 – 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.

GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel8.717.98 – 9.49
Placebo + 80 mg/m² Paclitaxel7.926.31 – 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).

GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel4.274.14 – 5.52
Placebo + 80 mg/m² Paclitaxel4.072.92 – 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

GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel26.521.6 – 32.0
Placebo + 80 mg/m² Paclitaxel21.915.5 – 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

GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel4.343.12 – 5.22
Placebo + 80 mg/m² Paclitaxel2.832.56 – 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
GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel5.30± 1.18
Placebo + 80 mg/m² Paclitaxel8.43± 1.56
Functional scale: Physical functioning
GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel1.09± 0.82
Placebo + 80 mg/m² Paclitaxel1.20± 1.10
Functional scale: Role functioning
GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel0.60± 1.13
Placebo + 80 mg/m² Paclitaxel1.27± 1.49
Functional scale: Emotional functioning
GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel5.89± 0.90
Placebo + 80 mg/m² Paclitaxel4.72± 1.19
Functional scale: Cognitive functioning
GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel2.87± 0.84
Placebo + 80 mg/m² Paclitaxel2.12± 1.11
Functional scale: Social functioning
GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel2.71± 1.19
Placebo + 80 mg/m² Paclitaxel2.98± 1.59
Symptom scale: Fatigue
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel15.28± 1.36
Placebo + 80 mg/m² Paclitaxel10.17± 1.80
Symptom scale: Nausea and vomiting
GroupValue95% CI
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel8.57± 1.46
Placebo + 80 mg/m² Paclitaxel8.66± 1.95
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score Secondary · 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

GroupValue95% 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) Score Secondary · 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).

GroupValue95% 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.

8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
Serious: 100/293 (34%)
Deaths: 246/294
Placebo + 80 mg/m² Paclitaxel
Serious: 37/145 (26%)
Deaths: 123/146

Serious adverse events (90 terms)

ReactionSystem8 mg/kg Ramucirumab + 80 m…Placebo + 80 mg/m² Paclita…
Neutrophil count decreasedInvestigations
Febrile neutropeniaBlood and lymphatic system disorders
White blood cell count decreasedInvestigations
PneumoniaInfections and infestations
Upper gastrointestinal haemorrhageGastrointestinal disorders
Platelet count decreasedInvestigations
PyrexiaGeneral disorders
AnaemiaBlood and lymphatic system disorders
Bone marrow toxicityBlood and lymphatic system disorders
IleusGastrointestinal disorders
VomitingGastrointestinal disorders
Abdominal painGastrointestinal disorders
Gastrointestinal haemorrhageGastrointestinal disorders
Intestinal obstructionGastrointestinal disorders
MalaiseGeneral disorders
Hepatic function abnormalHepatobiliary disorders
SepsisInfections and infestations
Abdominal distensionGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
AscitesGastrointestinal disorders
Obstruction gastricGastrointestinal disorders
FatigueGeneral disorders
Multiple organ dysfunction syndromeGeneral disorders
HypokalaemiaMetabolism and nutrition disorders
Cerebral infarctionNervous system disorders
Other adverse events (58 terms — click to expand)

ReactionSystem8 mg/kg Ramucirumab + 80 m…Placebo + 80 mg/m² Paclita…
White blood cell count decreasedInvestigations
Neutrophil count decreasedInvestigations
AnaemiaBlood and lymphatic system disorders
Aspartate aminotransferase increasedInvestigations
ProteinuriaRenal and urinary disorders
HypoalbuminaemiaMetabolism and nutrition disorders
Alanine aminotransferase increasedInvestigations
Platelet count decreasedInvestigations
AlopeciaSkin and subcutaneous tissue disorders
Decreased appetiteMetabolism and nutrition disorders
MalaiseGeneral disorders
DiarrhoeaGastrointestinal disorders
HypertensionVascular disorders
Blood bilirubin increasedInvestigations
Weight decreasedInvestigations
NauseaGastrointestinal disorders
PyrexiaGeneral disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
VomitingGastrointestinal disorders
ConstipationGastrointestinal disorders
Abdominal distensionGastrointestinal disorders
HypocalcaemiaMetabolism and nutrition disorders
Abdominal painGastrointestinal disorders
InsomniaPsychiatric disorders
Gamma-glutamyltransferase increasedInvestigations
HypoaesthesiaNervous system disorders
Oedema peripheralGeneral disorders
Blood alkaline phosphatase increasedInvestigations
HypokalaemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
HyponatraemiaMetabolism and nutrition disorders
CoughRespiratory, thoracic and mediastinal disorders
FatigueGeneral disorders
Abdominal pain upperGastrointestinal disorders
Lymphocyte count decreasedInvestigations
HyperglycaemiaMetabolism and nutrition disorders
ParaesthesiaNervous system disorders
Upper respiratory tract infectionInfections and infestations
PainGeneral disorders
HypophosphataemiaMetabolism and nutrition disorders

Most-reported serious reactions: Neutrophil count decreased, Febrile neutropenia, White blood cell count decreased, Pneumonia, Upper gastrointestinal haemorrhage, Platelet count decreased, Pyrexia, Anaemia.

Data from ClinicalTrials.gov NCT02898077 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab in participants with gastric and gastroesophageal cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting Tumor Microenvironment for Cancer Therapy.
    Roma-Rodrigues C, Mendes R, Baptista PV, Fernandes AR. · · 2019 · cited 865× · PMID 30781344 · DOI 10.3390/ijms20040840
  2. Efficacy and safety of weekly paclitaxel with or without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma (RAINBOW-Asia): a randomised, multicentre, double-blind, phase 3 trial.
    Xu RH, Zhang Y, Pan H, Feng J, et al · · 2021 · cited 81× · PMID 34626550 · DOI 10.1016/s2468-1253(21)00313-7
  3. Comparative genomic analysis of esophageal squamous cell carcinoma and adenocarcinoma: New opportunities towards molecularly targeted therapy.
    Zhang X, Wang Y, Meng L. · · 2022 · cited 39× · PMID 35530133 · DOI 10.1016/j.apsb.2021.09.028
  4. Immunometabolism: new insights and lessons from antigen-directed cellular immune responses.
    Ramalho R, Rao M, Zhang C, Agrati C, et al · · 2020 · cited 39× · PMID 32519148 · DOI 10.1007/s00281-020-00798-w
  5. Decoding tumor angiogenesis: pathways, mechanisms, and future directions in anti-cancer strategies.
    Liu X, Zhang J, Yi T, Li H, et al · · 2025 · cited 36× · PMID 40251641 · DOI 10.1186/s40364-025-00779-x
  6. Advances in targeting tumor microenvironment for immunotherapy.
    Wang L, Zhang L, Zhang Z, Wu P, et al · · 2024 · cited 34× · PMID 39421736 · DOI 10.3389/fimmu.2024.1472772
  7. New therapeutic options opened by the molecular classification of gastric cancer.
    Chivu-Economescu M, Matei L, Necula LG, Dragu DL, et al · · 2018 · cited 33× · PMID 29760539 · DOI 10.3748/wjg.v24.i18.1942
  8. Advances in targeted therapy and immunotherapy for esophageal cancer.
    Yang H, Li X, Yang W. · · 2023 · cited 27× · PMID 37403208 · DOI 10.1097/cm9.0000000000002768

Verify or expand the search:

Other trials of Ramucirumab

Trials testing the same drug.

Other recruiting trials for Gastroesophageal Junction Adenocarcinoma

Currently open trials in the same condition.

Other Eli Lilly and Company trials

Trials by the same sponsor.

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Data sources for this page

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.

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