Trial · NCT02898077

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

NCT02898077, Phase 3, Completed, Eli Lilly and Company; results first posted 2021-08-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer. Trials, record NCT02898077. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02898077

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer
NCT number: NCT02898077
Status: Completed
Phases: Phase 3
Enrollment: 440 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Gastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma
Interventions: Ramucirumab, Paclitaxel, Placebo
First posted: 2016-09-13
Last updated: 2022-06-14
Results first posted: 2021-08-03

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS)	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, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Primary	Overall Survival (OS)	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.
Secondary	Time to Progression (TTP)	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).
Secondary	Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	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 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.
Secondary	Duration of Objective Response (DoR)	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 as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. 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.
Secondary	Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	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. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. Least square (LS) mean value of changing from baseline to short-term follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment\*Visit and baseline.
Secondary	Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	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. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short-term follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment\*Visit and baseline.
Secondary	Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score	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 state.
Secondary	Change From Baseline in Participant-Reported EQ-5D-3L Visual Analog Scale (VAS) Score	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).

Source ClinicalTrials.gov

Outcomes9

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 the Date of the First Radiographically Documented Progressive Disease or Death from Any Cause (Up To 30 Months)	All randomized participants. Censored participants: Ramucirumab +Paclitaxel = 67, Placebo + Paclitaxel = 16.	Months	MEDIAN
PRIMARY	Overall Survival (OS)	Randomization to Date of Death from Any Cause (Up To 37 Months)	All randomized participants. Censored participants: Ramucirumab +Paclitaxel = 52, Placebo + Paclitaxel = 25.	Months	MEDIAN
SECONDARY	Time to Progression (TTP)	Randomization to the Date of the First Radiographically Documented Progressive Disease (Up To 30 Months)	All randomized participants. Censored participants: Ramucirumab +Paclitaxel = 98, Placebo + Paclitaxel = 36.	Months	MEDIAN
SECONDARY	Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	Randomization to Objective Disease Progression (Up To 30 Months)	All randomized participants.	Percentage of participants	NUMBER
SECONDARY	Duration of Objective Response (DoR)	Date of Objective Response to the Date of the First Radiographically Documented Progressive Disease or Death Due to Any Cause (Up To 24 Months)	All randomized participants with response. Censored participants: Ramucirumab +Paclitaxel = 1, Placebo + Paclitaxel = 4.	Months	MEDIAN
SECONDARY	Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)	All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data at short term follow up for each EORTC QLQ-C30 items.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)	All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data at short term follow up for each EORTC QLQ-C30 items.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score	Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)	All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 3L data.	Units on a scale	MEAN
SECONDARY	Change From Baseline in Participant-Reported EQ-5D-3L Visual Analog Scale (VAS) Score	Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)	All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 3L data.	millimeter (mm)	MEAN

Source ClinicalTrials.gov

Results by group74

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression Free Survival (PFS)	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	4.14	95% Confidence Interval 3.71 to 4.30	Months
Progression Free Survival (PFS)	Placebo + 80 mg/m² Paclitaxel	3.15	95% Confidence Interval 2.83 to 4.14	Months
Overall Survival (OS)	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	8.71	95% Confidence Interval 7.98 to 9.49	Months
Overall Survival (OS)	Placebo + 80 mg/m² Paclitaxel	7.92	95% Confidence Interval 6.31 to 9.10	Months
Time to Progression (TTP)	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	4.27	95% Confidence Interval 4.14 to 5.52	Months
Time to Progression (TTP)	Placebo + 80 mg/m² Paclitaxel	4.07	95% Confidence Interval 2.92 to 4.17	Months
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	26.5	95% Confidence Interval 21.6 to 32.0	Percentage of participants
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	Placebo + 80 mg/m² Paclitaxel	21.9	95% Confidence Interval 15.5 to 29.5	Percentage of participants
Duration of Objective Response (DoR)	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	4.34	95% Confidence Interval 3.12 to 5.22	Months
Duration of Objective Response (DoR)	Placebo + 80 mg/m² Paclitaxel	2.83	95% Confidence Interval 2.56 to 4.14	Months

1 to 10 of 74Source ClinicalTrials.gov

See all 74 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	8 Milligram/Kilogram (mg/kg) Ramucirumab + 80 mg/Square Meter (mg/m²) Paclitaxel	294
Overall Study	STARTED	Placebo + 80 mg/m² Paclitaxel	146
Overall Study	Received at Least 1 Dose of Study Drug	8 Milligram/Kilogram (mg/kg) Ramucirumab + 80 mg/Square Meter (mg/m²) Paclitaxel	293
Overall Study	Received at Least 1 Dose of Study Drug	Placebo + 80 mg/m² Paclitaxel	145
Overall Study	COMPLETED	8 Milligram/Kilogram (mg/kg) Ramucirumab + 80 mg/Square Meter (mg/m²) Paclitaxel	246
Overall Study	COMPLETED	Placebo + 80 mg/m² Paclitaxel	123
Overall Study	NOT COMPLETED	8 Milligram/Kilogram (mg/kg) Ramucirumab + 80 mg/Square Meter (mg/m²) Paclitaxel	48
Overall Study	NOT COMPLETED	Placebo + 80 mg/m² Paclitaxel	23

Source ClinicalTrials.gov

Adverse events296

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	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	195	293	338
other	Anaemia	Blood and lymphatic system disorders	Placebo + 80 mg/m² Paclitaxel	94	145	161
other	Leukopenia	Blood and lymphatic system disorders	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	17	293	64
other	Leukopenia	Blood and lymphatic system disorders	Placebo + 80 mg/m² Paclitaxel	3	145	6
other	Neutropenia	Blood and lymphatic system disorders	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	16	293	59
other	Neutropenia	Blood and lymphatic system disorders	Placebo + 80 mg/m² Paclitaxel	2	145	3
other	Abdominal distension	Gastrointestinal disorders	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	47	293	54
other	Abdominal distension	Gastrointestinal disorders	Placebo + 80 mg/m² Paclitaxel	15	145	17
other	Abdominal pain	Gastrointestinal disorders	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	38	293	45
other	Abdominal pain	Gastrointestinal disorders	Placebo + 80 mg/m² Paclitaxel	26	145	32

1 to 10 of 296Source ClinicalTrials.gov

See all 296 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	246	294
Total, all-cause mortality	Placebo + 80 mg/m² Paclitaxel	123	146
Total, other adverse events	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	287	293
Total, other adverse events	Placebo + 80 mg/m² Paclitaxel	143	145
Total, serious adverse events	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel	100	293
Total, serious adverse events	Placebo + 80 mg/m² Paclitaxel	37	145

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34626550	DERIVED

Source PubMed

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
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel vs Placebo + 80 mg/m² Paclitaxel: deaths from any cause	Trial comparisons
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel vs Placebo + 80 mg/m² Paclitaxel: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02898077

GET https://conductscience.org/api/trials/v1/NCT02898077/results?page=2

API reference For AI assistants