Trial Outcomes & Findings for A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer (NCT NCT02898077)

Last Updated: 2022-06-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

440 participants

Primary outcome timeframe

Randomization to the Date of the First Radiographically Documented Progressive Disease or Death from Any Cause (Up To 30 Months)

Results posted on

2022-06-14

Participant Flow

In the Participant Flow, participants who completed were those who died on treatment or during follow-up.

Participant milestones

Participant milestones
Measure	8 Milligram/Kilogram (mg/kg) Ramucirumab + 80 mg/Square Meter (mg/m²) Paclitaxel 8 mg/kg ramucirumab was administered as an intravenous infusion (IV) on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Overall Study STARTED	294	146
Overall Study Received at Least 1 Dose of Study Drug	293	145
Overall Study COMPLETED	246	123
Overall Study NOT COMPLETED	48	23

Reasons for withdrawal

Reasons for withdrawal
Measure	8 Milligram/Kilogram (mg/kg) Ramucirumab + 80 mg/Square Meter (mg/m²) Paclitaxel 8 mg/kg ramucirumab was administered as an intravenous infusion (IV) on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Overall Study Enrolled/randomized, but never treated	1	1
Overall Study Lost to Follow-up	4	3
Overall Study Physician Decision	0	2
Overall Study Sponsor Decision	32	13
Overall Study Withdrawal by Subject	6	3
Overall Study Discontinued from treatment but refused follow-up	2	1
Overall Study Ended extension period	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel n=294 Participants 8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel n=146 Participants Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Total n=440 Participants Total of all reporting groups
Age, Continuous	56.00 years STANDARD_DEVIATION 11.49 • n=5 Participants	56.20 years STANDARD_DEVIATION 11.12 • n=7 Participants	56.10 years STANDARD_DEVIATION 11.35 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	50 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	205 Participants n=5 Participants	96 Participants n=7 Participants	301 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	290 Participants n=5 Participants	145 Participants n=7 Participants	435 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	257 Participants n=5 Participants	135 Participants n=7 Participants	392 Participants n=5 Participants
Region of Enrollment Malaysia	18 Participants n=5 Participants	7 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment Philippines	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Thailand	13 Participants n=5 Participants	2 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization to the Date of the First Radiographically Documented Progressive Disease or Death from Any Cause (Up To 30 Months)

Population: All randomized participants. Censored participants: Ramucirumab +Paclitaxel = 67, Placebo + Paclitaxel = 16.

Outcome measures

Outcome measures
Measure	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel n=294 Participants 8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel n=146 Participants Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Progression Free Survival (PFS)	4.14 Months Interval 3.71 to 4.3	3.15 Months Interval 2.83 to 4.14

PRIMARY outcome

Timeframe: Randomization to Date of Death from Any Cause (Up To 37 Months)

Population: All randomized participants. Censored participants: Ramucirumab +Paclitaxel = 52, Placebo + Paclitaxel = 25.

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.

Outcome measures

Outcome measures
Measure	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel n=294 Participants 8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel n=146 Participants Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Overall Survival (OS)	8.71 Months Interval 7.98 to 9.49	7.92 Months Interval 6.31 to 9.1

SECONDARY outcome

Timeframe: Randomization to the Date of the First Radiographically Documented Progressive Disease (Up To 30 Months)

Population: All randomized participants. Censored participants: Ramucirumab +Paclitaxel = 98, Placebo + Paclitaxel = 36.

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).

Outcome measures

Outcome measures
Measure	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel n=294 Participants 8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel n=146 Participants Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Time to Progression (TTP)	4.27 Months Interval 4.14 to 5.52	4.07 Months Interval 2.92 to 4.17

SECONDARY outcome

Timeframe: Randomization to Objective Disease Progression (Up To 30 Months)

Population: All randomized participants.

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.

Outcome measures

Outcome measures
Measure	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel n=294 Participants 8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel n=146 Participants Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	26.5 Percentage of participants Interval 21.6 to 32.0	21.9 Percentage of participants Interval 15.5 to 29.5

SECONDARY outcome

Timeframe: Date of Objective Response to the Date of the First Radiographically Documented Progressive Disease or Death Due to Any Cause (Up To 24 Months)

Population: All randomized participants with response. Censored participants: Ramucirumab +Paclitaxel = 1, Placebo + Paclitaxel = 4.

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.

Outcome measures

Outcome measures
Measure	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel n=78 Participants 8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel n=32 Participants Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Duration of Objective Response (DoR)	4.34 Months Interval 3.12 to 5.22	2.83 Months Interval 2.56 to 4.14

SECONDARY outcome

Timeframe: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel n=272 Participants 8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel n=133 Participants Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global health status	5.30 Units on a scale Standard Error 1.18	8.43 Units on a scale Standard Error 1.56
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Functional scale: Physical functioning	1.09 Units on a scale Standard Error 0.82	1.20 Units on a scale Standard Error 1.10
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Functional scale: Role functioning	0.60 Units on a scale Standard Error 1.13	1.27 Units on a scale Standard Error 1.49
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Functional scale: Emotional functioning	5.89 Units on a scale Standard Error 0.90	4.72 Units on a scale Standard Error 1.19
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Functional scale: Cognitive functioning	2.87 Units on a scale Standard Error 0.84	2.12 Units on a scale Standard Error 1.11
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Functional scale: Social functioning	2.71 Units on a scale Standard Error 1.19	2.98 Units on a scale Standard Error 1.59
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Fatigue	-4.20 Units on a scale Standard Error 1.14	-5.63 Units on a scale Standard Error 1.51
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Nausea and vomiting	-4.84 Units on a scale Standard Error 0.77	-3.80 Units on a scale Standard Error 1.03
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Pain	-6.89 Units on a scale Standard Error 1.07	-7.01 Units on a scale Standard Error 1.43
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Dyspnea	-2.18 Units on a scale Standard Error 0.95	-2.65 Units on a scale Standard Error 1.27
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Insomnia	-5.73 Units on a scale Standard Error 1.18	-7.06 Units on a scale Standard Error 1.57
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Appetite loss	-7.84 Units on a scale Standard Error 1.30	-10.26 Units on a scale Standard Error 1.73
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Constipation	-6.35 Units on a scale Standard Error 1.11	-5.41 Units on a scale Standard Error 1.48
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Diarrhea	-2.51 Units on a scale Standard Error 0.86	-3.03 Units on a scale Standard Error 1.14
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Financial difficulties	-8.49 Units on a scale Standard Error 1.60	-8.12 Units on a scale Standard Error 2.13

SECONDARY outcome

Timeframe: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel n=272 Participants 8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel n=133 Participants Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global health status	-14.42 Units on a scale Standard Error 1.32	-9.83 Units on a scale Standard Error 1.75
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Functional scale: Physical functioning	-14.31 Units on a scale Standard Error 1.30	-11.71 Units on a scale Standard Error 1.73
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Functional scale: Role functioning	-18.46 Units on a scale Standard Error 1.72	-14.39 Units on a scale Standard Error 2.28
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Functional scale: Emotional functioning	-9.80 Units on a scale Standard Error 1.30	-6.77 Units on a scale Standard Error 1.72
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Functional scale: Cognitive functioning	-13.66 Units on a scale Standard Error 1.40	-12.08 Units on a scale Standard Error 1.85
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Functional scale: Social functioning	-17.05 Units on a scale Standard Error 1.73	-16.52 Units on a scale Standard Error 2.30
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Fatigue	15.28 Units on a scale Standard Error 1.36	10.17 Units on a scale Standard Error 1.80
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Nausea and vomiting	8.57 Units on a scale Standard Error 1.46	8.66 Units on a scale Standard Error 1.95
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Pain	14.01 Units on a scale Standard Error 1.50	10.11 Units on a scale Standard Error 2.00
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Dyspnea	16.58 Units on a scale Standard Error 1.51	8.34 Units on a scale Standard Error 2.01
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Insomnia	14.14 Units on a scale Standard Error 1.74	7.97 Units on a scale Standard Error 2.32
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Appetite loss	17.06 Units on a scale Standard Error 1.85	11.11 Units on a scale Standard Error 2.46
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Constipation	8.39 Units on a scale Standard Error 1.57	6.58 Units on a scale Standard Error 2.08
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Diarrhea	13.41 Units on a scale Standard Error 1.39	5.67 Units on a scale Standard Error 1.85
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Symptom scale: Financial difficulties	10.11 Units on a scale Standard Error 1.80	9.32 Units on a scale Standard Error 2.39

SECONDARY outcome

Timeframe: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)

Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 3L data.

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.

Outcome measures

Outcome measures
Measure	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel n=123 Participants 8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel n=56 Participants Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score	-0.1351 Units on a scale Standard Deviation 0.2472	-0.1303 Units on a scale Standard Deviation 0.1765

SECONDARY outcome

Timeframe: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)

Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 3L data.

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).

Outcome measures

Outcome measures
Measure	8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel n=123 Participants 8 mg/kg ramucirumab was administered as an IV on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.	Placebo + 80 mg/m² Paclitaxel n=56 Participants Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Change From Baseline in Participant-Reported EQ-5D-3L Visual Analog Scale (VAS) Score	-9.6 millimeter (mm) Standard Deviation 20.11	-8.6 millimeter (mm) Standard Deviation 15.88

Adverse Events

8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel

Serious events: 100 serious events

Other events: 287 other events

Deaths: 246 deaths

Placebo + 80 mg/m² Paclitaxel

Serious events: 37 serious events

Other events: 143 other events

Deaths: 123 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60