Trial · NCT02314117
A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer
NCT02314117, Phase 3, Completed, Eli Lilly and Company; results first posted 2018-05-02
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer. Trials, record NCT02314117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02314117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer
- NCT number
- NCT02314117
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 645 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Interventions
- Ramucirumab, Capecitabine, Cisplatin, Placebo, Fluorouracil
- First posted
- 2014-12-10
- Last updated
- 2021-08-26
- Other registries' IDs
- eudract:2014-002240-40
- Results first posted
- 2018-05-02
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | 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 visits,censoring occurred at the date of the last rgr visit prior to the missed visits.If death or PD occurred after postdiscontinuation(pdis) systemic anticancer therapy,censoring occurred at the date of last rgr visit prior to the start of pdis systemic anticancer therapy. PD was defined according to RECIST v.1.1. |
| Secondary | Overall Survival (OS) | 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. |
| Secondary | Progression- Free Survival 2 (PFS2) | 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 progression is observed or not(e.g. at the end of study treatment). It is assessed by investigator based on overall clinical evaluation, not limited to RECIST. |
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | 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 nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).ORR calculated as:(sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100. |
| Secondary | Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) | 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 shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s). |
| Secondary | Time to Progression (TTP) | 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). |
| Secondary | Duration of Response (DoR) | 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 nodes must be non-pathological in size. Non-CR/Non-PD:Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels.PD:Unequivocal progression of existing lesions or the appearance of new lesion(s).If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date,DOR was censored at the date of the last adequate tumor assessment. |
| Secondary | 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 Scale | 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. |
| Secondary | Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L) | 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. |
| Secondary | Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months) | First 508 randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=87 and Placebo + Cisplatin + Capecitabine=62. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization to Death from Any Cause (Up To 30 Months) | All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=87 and Placebo + Cisplatin + Capecitabine=88. | months | MEDIAN |
| SECONDARY | Progression- Free Survival 2 (PFS2) | 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) | All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=74 and Placebo + Cisplatin + Capecitabine=74. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | Randomization to Disease Progression (Up To 26 Months) | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) | Randomization to Disease Progression (Up To 26 Months) | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Time to Progression (TTP) | Randomization to Disease Progression (Up To 24 Months) | All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=149 and Placebo + Cisplatin + Capecitabine=111. | months | MEDIAN |
| SECONDARY | Duration of Response (DoR) | 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) | All randomized participants. Participants censored : Ramucirumab + Cisplatin + Capecitabine= 23 and Placebo + Cisplatin + Capecitabine=10. | months | MEDIAN |
| SECONDARY | 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 Scale | Randomization, First worsening in QoL (Up To 26 Months) | All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=215 and Placebo + Cisplatin + Capecitabine=217 | months | MEDIAN |
| SECONDARY | Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L) | Randomization, 30 Days After Treatment Discontinuation (Up To 5 Months) | All randomized participants who provided data at baseline and cycle 6. | units on a scale | MEAN |
| SECONDARY | Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | Randomization to ECOG PS ≥2 (Up To 26 Months) | All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=254 and Placebo + Cisplatin + Capecitabine= 260. | months | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Ramucirumab + Cisplatin + Capecitabine | 5.72 | 95% Confidence Interval 5.45 to 6.51 | months | |
| Progression-free Survival (PFS) | Placebo + Cisplatin + Capecitabine | 5.39 | 95% Confidence Interval 4.47 to 5.72 | months | |
| Overall Survival (OS) | Ramucirumab + Cisplatin + Capecitabine | 11.17 | 95% Confidence Interval 9.92 to 11.93 | months | |
| Overall Survival (OS) | Placebo + Cisplatin + Capecitabine | 10.74 | 95% Confidence Interval 9.53 to 11.89 | months | |
| Progression- Free Survival 2 (PFS2) | Ramucirumab + Cisplatin + Capecitabine | 10.18 | 95% Confidence Interval 9.03 to 10.84 | months | |
| Progression- Free Survival 2 (PFS2) | Placebo + Cisplatin + Capecitabine | 9.20 | 95% Confidence Interval 8.34 to 9.99 | months | |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | Ramucirumab + Cisplatin + Capecitabine | 41.1 | 95% Confidence Interval 35.8 to 46.4 | percentage of participants | |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | Placebo + Cisplatin + Capecitabine | 36.4 | 95% Confidence Interval 31.1 to 41.6 | percentage of participants | |
| Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) | Ramucirumab + Cisplatin + Capecitabine | 81.9 | 95% Confidence Interval 77.7 to 86.1 | percentage of participants | |
| Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) | Placebo + Cisplatin + Capecitabine | 76.5 | 95% Confidence Interval 71.8 to 81.1 | percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ramucirumab + Cisplatin + Capecitabine | 326 | |
| Overall Study | STARTED | Placebo + Cisplatin + Capecitabine | 319 | |
| Overall Study | Received at Least One Dose of Study Drug | Ramucirumab + Cisplatin + Capecitabine | 323 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo + Cisplatin + Capecitabine | 315 | |
| Overall Study | COMPLETED | Ramucirumab + Cisplatin + Capecitabine | 314 | |
| Overall Study | COMPLETED | Placebo + Cisplatin + Capecitabine | 303 | |
| Overall Study | NOT COMPLETED | Ramucirumab + Cisplatin + Capecitabine | 12 | |
| Overall Study | NOT COMPLETED | Placebo + Cisplatin + Capecitabine | 16 |
Source ClinicalTrials.gov
Adverse events506
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | LY3009806+Capecitabine+Cisplatin | 104 | 323 | 276 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo+Capecitabine+Cisplatin | 114 | 315 | 289 |
| other | Neutropenia | Blood and lymphatic system disorders | LY3009806+Capecitabine+Cisplatin | 71 | 323 | 218 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo+Capecitabine+Cisplatin | 74 | 315 | 133 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | LY3009806+Capecitabine+Cisplatin | 41 | 323 | 106 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo+Capecitabine+Cisplatin | 26 | 315 | 51 |
| other | Tinnitus | Ear and labyrinth disorders | LY3009806+Capecitabine+Cisplatin | 23 | 323 | 26 |
| other | Tinnitus | Ear and labyrinth disorders | Placebo+Capecitabine+Cisplatin | 27 | 315 | 32 |
| other | Abdominal pain | Gastrointestinal disorders | LY3009806+Capecitabine+Cisplatin | 52 | 323 | 80 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo+Capecitabine+Cisplatin | 51 | 315 | 69 |
1 to 10 of 506Source ClinicalTrials.gov
See all 506 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY3009806+Capecitabine+Cisplatin | ||
| Total, all-cause mortality | Placebo+Capecitabine+Cisplatin | ||
| Total, other adverse events | LY3009806+Capecitabine+Cisplatin | 315 | 323 |
| Total, other adverse events | Placebo+Capecitabine+Cisplatin | 304 | 315 |
| Total, serious adverse events | LY3009806+Capecitabine+Cisplatin | 161 | 323 |
| Total, serious adverse events | Placebo+Capecitabine+Cisplatin | 150 | 315 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ramucirumab + Cisplatin + Capecitabine vs Placebo + Cisplatin + Capecitabine: Number of Participants With Anti-Ramucirumab Antibodies | Trial comparisons |
| LY3009806+Capecitabine+Cisplatin vs Placebo+Capecitabine+Cisplatin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02314117
GET https://conductscience.org/api/trials/v1/NCT02314117/results?page=2