A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) (RELAY)

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ClinicalTrials.gov Identifier: NCT02411448

Recruitment Status : Active, not recruiting

First Posted : April 8, 2015

Results First Posted : March 4, 2020

Last Update Posted : March 18, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Metastatic Non-Small Cell Lung Cancer
Interventions	Drug: Ramucirumab Drug: Placebo Drug: Erlotinib Drug: Gefitinib Drug: Osimertinib
Enrollment	545

Participant Flow

Recruitment Details

Pre-assignment Details

This study consists of 3 parts:

Part A: Open-label.
Part B: Randomized, double-blind and placebo-controlled.
Part C: Open-label.

Part C data will be reported after study completion.


Arm/Group Title	Part A: Ramucirumab + Erlotinib	Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib
Arm/Group Description	Part A: 10 milligrams per kilogram ...	Part B: 10 mg/kg ramucirumab admini...	Part B: Placebo administered every ...
Arm/Group Description	Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Period Title: Overall Study
Started	14	224	225
Received at Least One Dose of Study Drug	14	221	225
Completed	10	141	173
Not Completed	4	83	52
Reason Not Completed
Withdrawal by Subject	1	14	9
Other	0	2	0
Did not receive study treatment	0	3	0
Alive on study treatment	3	64	43

Baseline Characteristics

Arm/Group Title		Part A: Ramucirumab + Erlotinib	Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib	Total
Arm/Group Description		Part A: 10 milligrams per kilogram ...	Part B: 10 mg/kg ramucirumab admini...	Part B: Placebo administered every ...	Total of all reporting groups
Arm/Group Description		Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Total of all reporting groups
Overall Number of Baseline Participants		14	224	225	463
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All enrolled participants. Part C data will be reported after study completion.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years	Number Analyzed	14 participants	224 participants	225 participants	463 participants
Part A		67.6 (13.2)	NA ^[1] (NA)	NA ^[1] (NA)	67.6 (13)
Part B		NA ^[2] (NA)	63.7 (10.2)	62.9 (10.6)	63.3 (10.4)
		[1] Row represents Part A data only. [2] Row represents Part B data only.
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	14 participants	224 participants	225 participants	463 participants
	Female	11	141	142	294
	Male	3	83	83	169
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	14 participants	224 participants	225 participants	463 participants
	Hispanic or Latino	0	13	10	23
	Not Hispanic or Latino	1	150	160	311
	Unknown or Not Reported	13	61	55	129
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	14 participants	224 participants	225 participants	463 participants
	American Indian or Alaska Native	0	0	1	1
	Asian	7	172	174	353
	Native Hawaiian or Other Pacific Islander	0	0	0	0
	Black or African American	0	0	1	1
	White	7	52	48	107
	More than one race	0	0	0	0
	Unknown or Not Reported	0	0	1	1
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	14 participants	224 participants	225 participants	463 participants
Romania		0	2	0	2
Hong Kong		0	9	6	15
United States		0	7	2	9
Japan		7	106	105	218
United Kingdom		0	4	3	7
Spain		7	23	19	49
Canada		0	0	2	2
South Korea		0	25	29	54
Turkey		0	3	4	7
Taiwan		0	26	30	56
Italy		0	8	12	20
France		0	4	7	11
Germany		0	7	6	13
Geographic Region ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	14 participants	224 participants	225 participants	463 participants
East Asia		7	166	170	343
Other*		7	58	55	120
		[1] Measure Description: * Geographic region "Other" includes Canada, France, Germany, Italy, Romania, Spain, Turkey, US, UK.

Outcome Measures

1.Primary Outcome


Title	Part B: Progression Free Survival (PFS)
Description	PFS is defined as the time from the date of randomization to the date ...
Description	PFS is defined as the time from the date of randomization to the date of radiographically documented progressive disease (PD) based on investigator assessment, or the date of death due to any cause, whichever is first assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Time Frame	Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months)

Outcome Measure Data

Analysis Population Description

Part B: All randomized participants grouped according to their assigned treatment at randomization. Censored participants were: Part B: Ramucirumab+ Erlotinib= 102 and Part B: Placebo+ Erlotinib= 67. Per protocol, Part A did not evaluate efficacy.


Arm/Group Title	Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib
Arm/Group Description:	Part B: 10 mg/kg ramucirumab admini...	Part B: Placebo administered every ...
Arm/Group Description:	Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed	224	225
Median (95% Confidence Interval) Unit of Measure: Months
	19.4 (15.4 to 21.6)	12.4 (11.0 to 13.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part B: Ramucirumab+ Erlotinib, Part B: Placebo+ Erlotinib
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.591
	Confidence Interval	(2-Sided) 95% 0.461 to 0.760
	Estimation Comments	[Not Specified]

2.Primary Outcome


Title	Number of Participants With Treatment-Emergent Adverse Events
Description	A summary of other non-serious adverse events and all serious adverse ...
Description	A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame	Cycle 1 Day 1 through End of Study (Up To 3 Years)

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.


Arm/Group Title	Part A: Ramucirumab + Erlotinib	Part B: Ramucirumab + Erlotinib	Part B: Placebo + Erlotinib
Arm/Group Description:	Part A: 10 milligrams per kilogram ...	Part B: 10 mg/kg ramucirumab admini...	Part B: Placebo administered every ...
Arm/Group Description:	Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed	14	221	225
Measure Type: Count of Participants Unit of Measure: Participants
	14	221	225

3.Secondary Outcome


Title	Part B: Overall Survival (OS)
Description	OS was defined as the time from the date of randomization to the date ...
Description	OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who was not known to have died as of the data-inclusion cutoff date for a particular analysis,OS was censored for that analysis at the date of last contact prior to the data-inclusion cutoff date (contacts considered in the determination of last contact date include adverse event (AE) date, lesion assessment date, visit date, and last known alive date).
Time Frame	Randomization to Date of Death from Any Cause (Up To 37 Months)

Outcome Measure Data

Analysis Population Description

Part B: All randomized participants grouped according to their assigned treatment at randomization. Censored participants were: Part B: Ramucirumab+ Erlotinib= 187 and Part B: Placebo+ Erlotinib= 183. Per protocol, Part A did not evaluate efficacy.


Arm/Group Title	Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib
Arm/Group Description:	Part B: 10 mg/kg ramucirumab admini...	Part B: Placebo administered every ...
Arm/Group Description:	Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed	224	225
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

There were not enough events/deaths to compute a median or 95% confidence interval.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part B: Ramucirumab+ Erlotinib, Part B: Placebo+ Erlotinib
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.4209
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.832
	Confidence Interval	(2-Sided) 95% 0.532 to 1.303
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Description	ORR was defined as the percentage of randomized participants achieving...
Description	ORR was defined as the percentage of randomized participants achieving a best overall response of partial response (PR) or complete response (CR) assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Time Frame	Randomization to Progressive Disease (Up To 37 Months)

Outcome Measure Data

Analysis Population Description

Part B: All randomized participants grouped according to their assigned treatment at randomization. Per protocol, Part A did not evaluate efficacy.


Arm/Group Title	Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib
Arm/Group Description:	Part B: 10 mg/kg ramucirumab admini...	Part B: Placebo administered every ...
Arm/Group Description:	Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed	224	225
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	76.3 (70.8 to 81.9)	74.7 (69.0 to 80.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part B: Ramucirumab+ Erlotinib, Part B: Placebo+ Erlotinib
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7413
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

5.Secondary Outcome


Title	Part B: Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])
Description	DCR was defined as the percentage of randomized participants achieving...
Description	DCR was defined as the percentage of randomized participants achieving a best overall response of CR,PR, or stable disease(SD) assessed via Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1. CR was defined as the disappearance of all lesions,pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions.PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease(PD) was at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.
Time Frame	Randomization to Progressive Disease (Up To 37 Months)

Outcome Measure Data

Analysis Population Description

Part B: All randomized participants grouped according to their assigned treatment at randomization. Per protocol, Part A did not evaluate efficacy.


Arm/Group Title	Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib
Arm/Group Description:	Part B: 10 mg/kg ramucirumab admini...	Part B: Placebo administered every ...
Arm/Group Description:	Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed	224	225
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	95.1 (92.3 to 97.9)	95.6 (92.9 to 98.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part B: Ramucirumab+ Erlotinib, Part B: Placebo+ Erlotinib
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	1.0000
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

6.Secondary Outcome


Title	Part B: Duration of Response (DoR)
Description	DoR was defined as the date of first documented CR or PR (responder) t...
Description	DoR was defined as the date of first documented CR or PR (responder) to the date of progressive disease or the date of death due to any cause, whichever was earlier. If a responder was not known to have died or have progressive disease, then the participant was censored at the date of last evaluable tumor assessment.CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Time Frame	Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 37 Months)

Outcome Measure Data

Analysis Population Description

Part B: All randomized participants grouped according to their assigned treatment at randomization that had a response (CR or PR). Per protocol, Part A did not evaluate efficacy.


Arm/Group Title	Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib
Arm/Group Description:	Part B: 10 mg/kg ramucirumab admini...	Part B: Placebo administered every ...
Arm/Group Description:	Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed	171	168
Median (95% Confidence Interval) Unit of Measure: months
	18.0 (13.9 to 19.8)	11.1 (9.7 to 12.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part B: Ramucirumab+ Erlotinib, Part B: Placebo+ Erlotinib
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.619
	Confidence Interval	(2-Sided) 95% 0.477 to 0.805
	Estimation Comments	[Not Specified]

7.Secondary Outcome


Title	Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Description	Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucir...
Description	Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Time Frame	Cycle 2 Day 1: Predose; Cycle 4 Day 1: Predose; Cycle 7 Day 1: Predose; Cycle 14 Day 1

Outcome Measure Data

Analysis Population Description

Part B participants who received at least one dose of Ramucirumab+ Erlotinib who had evaluable PK data. Per protocol, Part A did not evaluate PK.


Arm/Group Title		Part B: Ramucirumab+ Erlotinib
Arm/Group Description:		Part B: 10 mg/kg ramucirumab every ...
Arm/Group Description:		Part B: 10 mg/kg ramucirumab every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed		185
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: microgram per milliliter (µg/mL)
Cycle 2	Number Analyzed	185 participants
Cycle 2		39.6 (32%)
Cycle 4	Number Analyzed	145 participants
Cycle 4		68.5 (37%)
Cycle 7	Number Analyzed	110 participants
Cycle 7		85.7 (32%)
Cycle 14	Number Analyzed	59 participants
Cycle 14		99.4 (31%)

8.Secondary Outcome


Title	Part B: Number of Participants With Anti-Ramucirumab Antibodies
Description	Part B: Number of Participants With Anti-Ramucirumab Antibodies.
Description	Part B: Number of Participants With Anti-Ramucirumab Antibodies.
Time Frame	Cycle 1 Predose through Follow-up (Up To 37 Months)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug. Per protocol, Part A did not evaluate Anti-Ramucirumab Antibodies .


Arm/Group Title	Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib
Arm/Group Description:	Part B: 10 mg/kg ramucirumab admini...	Part B: Placebo administered every ...
Arm/Group Description:	Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed	221	225
Measure Type: Count of Participants Unit of Measure: Participants
	14	18

9.Secondary Outcome


Title	Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS)
Description	The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms...
Description	The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-millimeter (mm) lines. A higher score for any item represented a higher level of symptoms/problems. The LCSS total score was defined as the mean of all 9 items. Average symptom burden index (ASBI) was calculated as the mean of the six symptom-specific questions from the LCSS. Potential scores range from 0 (for best outcome) to 100 (for worst outcome).
Time Frame	Baseline, End of Study (Up To 37 Months)

Outcome Measure Data

Analysis Population Description

Part B: All randomized participants who completed the LCSS at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.


Arm/Group Title		Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib
Arm/Group Description:		Part B: 10 mg/kg ramucirumab admini...	Part B: Placebo administered every ...
Arm/Group Description:		Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed		224	225
Least Squares Mean (Standard Error) Unit of Measure: millimeter
Loss of Appetite	Number Analyzed	213 participants	217 participants
Loss of Appetite		-17.07 (0.92)	-18.16 (0.91)
Fatigue	Number Analyzed	213 participants	217 participants
Fatigue		-19.35 (0.91)	-19.45 (0.90)
Cough	Number Analyzed	213 participants	217 participants
Cough		-21.22 (0.58)	-22.09 (0.57)
Shortness of Breath	Number Analyzed	213 participants	217 participants
Shortness of Breath		-14.46 (0.57)	-15.93 (0.57)
Blood in Sputum	Number Analyzed	213 participants	216 participants
Blood in Sputum		-1.58 (0.25)	-1.94 (0.25)
Pain	Number Analyzed	213 participants	216 participants
Pain		-13.57 (0.59)	-14.69 (0.59)
Symptom distress	Number Analyzed	213 participants	217 participants
Symptom distress		-15.91 (0.67)	-16.15 (0.67)
Interference with Activity Level	Number Analyzed	213 participants	217 participants
Interference with Activity Level		-14.43 (0.83)	-15.60 (0.82)
Global Quality of Life	Number Analyzed	213 participants	217 participants
Global Quality of Life		-16.21 (0.95)	-18.12 (0.94)
Average Symptom Burden Index	Number Analyzed	213 participants	216 participants
Average Symptom Burden Index		-12.17 (0.57)	-13.05 (0.57)
Total LCSS	Number Analyzed	213 participants	216 participants
Total LCSS		-12.00 (0.62)	-12.71 (0.61)

10.Secondary Outcome


Title	Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
Description	The EQ-5D-5L is a standardized instrument used to measure self-reporte...
Description	The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
Time Frame	Baseline, Cycle 10 (each cycle is 2 weeks)

Outcome Measure Data

Analysis Population Description

Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.


Arm/Group Title	Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib
Arm/Group Description:	Part B: 10 mg/kg ramucirumab every ...	Part B: Placebo every 2 weeks IV in...
Arm/Group Description:	Part B: 10 mg/kg ramucirumab every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed	170	170
Mean (Standard Deviation) Unit of Measure: score on a scale
	0.02 (0.15)	0.02 (0.15)

11.Secondary Outcome


Title	Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
Description	The EQ-5D-5L is a standardized instrument used to measure self-reporte...
Description	The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
Time Frame	Baseline, Cycle 28 (each cycle is 2 weeks)

Outcome Measure Data

Analysis Population Description

Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.


Arm/Group Title	Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib
Arm/Group Description:	Part B: 10 mg/kg ramucirumab every ...	Part B: Placebo every 2 weeks IV in...
Arm/Group Description:	Part B: 10 mg/kg ramucirumab every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed	108	81
Mean (Standard Deviation) Unit of Measure: score on a scale
	0.02 (0.18)	0.01 (0.1)

12.Secondary Outcome


Title	Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
Description	The EQ-5D-5L is a standardized instrument used to measure self-reporte...
Description	The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
Time Frame	Baseline, Cycle 40 (each cycle is 2 weeks)

Outcome Measure Data

Analysis Population Description

Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.


Arm/Group Title	Part B: Ramucirumab+ Erlotinib	Part B: Placebo+ Erlotinib
Arm/Group Description:	Part B: 10 mg/kg ramucirumab every ...	Part B: Placebo every 2 weeks IV in...
Arm/Group Description:	Part B: 10 mg/kg ramucirumab every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.	Part B: Placebo every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed	57	44
Mean (Standard Deviation) Unit of Measure: score on a scale
	0.01 (0.15)	-0.01 (0.14)

Adverse Events

Time Frame	Up To 3 Years
Adverse Event Reporting Description	Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants. Part C data will be reported after study completion. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Arm/Group Title	Part A: Ramucirumab + Erlotinib		Part B: Ramucirumab + Erlotinib		Part B: Placebo + Erlotinib
Arm/Group Description	Part A: 10 milligrams per kilogram ...		Part B: 10 mg/kg ramucirumab admini...		Part B: Placebo administered every ...
Arm/Group Description	Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.		Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.		Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
All-Cause Mortality
	Part A: Ramucirumab + Erlotinib		Part B: Ramucirumab + Erlotinib		Part B: Placebo + Erlotinib
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	2/14 (14.29%)		37/224 (16.52%)		42/225 (18.67%)
Serious Adverse Events Serious Adverse Events
	Part A: Ramucirumab + Erlotinib		Part B: Ramucirumab + Erlotinib		Part B: Placebo + Erlotinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0.00%)		65/221 (29.41%)		47/225 (20.89%)
Blood and lymphatic system disorders
Anaemia ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	2	0/225 (0.00%)	0
Cardiac disorders
Cardiac failure ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Cardiac failure congestive ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	2	0/225 (0.00%)	0
Myocardial infarction ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Pericardial effusion ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Wolff-parkinson-white syndrome ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Eye disorders
Cataract ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	2/225 (0.89%)	3
Macular fibrosis ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Retinal detachment ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	4
Gastrointestinal disorders
Abdominal distension ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Abdominal pain ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Colitis ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Colitis ischaemic ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Constipation ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	1/225 (0.44%)	1
Diarrhoea ^† 1	0/14 (0.00%)	0	3/221 (1.36%)	3	1/225 (0.44%)	1
Duodenal ulcer ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Dyspepsia ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Gastrooesophageal reflux disease ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Haemorrhoids ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Irritable bowel syndrome ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Lower gastrointestinal haemorrhage ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Melaena ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	1/225 (0.44%)	1
Nausea ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	2/225 (0.89%)	3
Small intestinal haemorrhage ^† 1	0/14 (0.00%)	0	2/221 (0.90%)	2	0/225 (0.00%)	0
Stomatitis ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Upper gastrointestinal haemorrhage ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Vomiting ^† 1	0/14 (0.00%)	0	2/221 (0.90%)	3	1/225 (0.44%)	2
General disorders
Asthenia ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Fatigue ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
General physical health deterioration ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	2	0/225 (0.00%)	0
Malaise ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Mucous membrane disorder ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Non-cardiac chest pain ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Pyrexia ^† 1	0/14 (0.00%)	0	3/221 (1.36%)	3	4/225 (1.78%)	4
Hepatobiliary disorders
Drug-induced liver injury ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	2
Hepatic function abnormal ^† 1	0/14 (0.00%)	0	3/221 (1.36%)	5	2/225 (0.89%)	3
Hepatic steatosis ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Hepatitis ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Liver disorder ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Immune system disorders
Hypersensitivity ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Infections and infestations
Abdominal infection ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Appendicitis perforated ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Cellulitis ^† 1	0/14 (0.00%)	0	4/221 (1.81%)	5	0/225 (0.00%)	0
Diverticulitis ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Empyema ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Encephalitis influenzal ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Gastroenteritis ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	2	0/225 (0.00%)	0
Gastroenteritis bacterial ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Herpes zoster ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Infectious pleural effusion ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	2
Lung infection ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	1/225 (0.44%)	1
Meningitis ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Pneumonia ^† 1	0/14 (0.00%)	0	7/221 (3.17%)	9	1/225 (0.44%)	1
Pneumonia bacterial ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Rash pustular ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Sepsis ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Septic shock ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Skin infection ^† 1	0/14 (0.00%)	0	2/221 (0.90%)	2	0/225 (0.00%)	0
Tonsillitis ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Upper respiratory tract infection ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Urinary tract infection ^† 1	0/14 (0.00%)	0	2/221 (0.90%)	3	0/225 (0.00%)	0
Injury, poisoning and procedural complications
Concussion ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Fall ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Humerus fracture ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Infusion related reaction ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	1/225 (0.44%)	1
Radius fracture ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Rib fracture ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Ulna fracture ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Investigations
Alanine aminotransferase increased ^† 1	0/14 (0.00%)	0	2/221 (0.90%)	3	1/225 (0.44%)	3
Aspartate aminotransferase increased ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	1/225 (0.44%)	2
Blood creatinine increased ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite ^† 1	0/14 (0.00%)	0	3/221 (1.36%)	8	0/225 (0.00%)	0
Hyperglycaemia ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Hypokalaemia ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Hyponatraemia ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	1/225 (0.44%)	1
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Back pain ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	2/225 (0.89%)	3
Neck pain ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Basal cell carcinoma ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Cancer pain ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Lymphoma ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Mesenteric neoplasm ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Ovarian neoplasm ^† 1	0/11 (0.00%)	0	1/139 (0.72%)	1	0/142 (0.00%)	0
Pericarditis malignant ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Nervous system disorders
Depressed level of consciousness ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	2
Dizziness ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Hydrocephalus ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Neuralgia ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Somnolence ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Transient ischaemic attack ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Psychiatric disorders
Adjustment disorder ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Renal and urinary disorders
Acute kidney injury ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	2	0/225 (0.00%)	0
Proteinuria ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Renal failure ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Reproductive system and breast disorders
Endometriosis ^† 1	0/11 (0.00%)	0	0/139 (0.00%)	0	1/142 (0.70%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Dysphonia ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Dyspnoea ^† 1	0/14 (0.00%)	0	2/221 (0.90%)	2	1/225 (0.44%)	1
Dyspnoea exertional ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Haemoptysis ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	1/225 (0.44%)	1
Haemothorax ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Interstitial lung disease ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	2	2/225 (0.89%)	3
Pleural effusion ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Pleurisy ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Pneumomediastinum ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Pneumonitis ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	2	0/225 (0.00%)	0
Pneumothorax ^† 1	0/14 (0.00%)	0	4/221 (1.81%)	5	3/225 (1.33%)	3
Pulmonary embolism ^† 1	0/14 (0.00%)	0	2/221 (0.90%)	2	2/225 (0.89%)	2
Skin and subcutaneous tissue disorders
Dermatitis acneiform ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Dermatitis exfoliative generalised ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Eczema asteatotic ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Skin exfoliation ^† 1	0/14 (0.00%)	0	1/221 (0.45%)	1	0/225 (0.00%)	0
Surgical and medical procedures
Hepatectomy ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Vascular disorders
Embolism ^† 1	0/14 (0.00%)	0	0/221 (0.00%)	0	1/225 (0.44%)	1
Hypertension ^† 1	0/14 (0.00%)	0	2/221 (0.90%)	2	0/225 (0.00%)	0
Hypotension ^† 1	0/14 (0.00%)	0	2/221 (0.90%)	2	0/225 (0.00%)	0
1 Term from vocabulary, MedDRA 21.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Part A: Ramucirumab + Erlotinib		Part B: Ramucirumab + Erlotinib		Part B: Placebo + Erlotinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/14 (100.00%)		220/221 (99.55%)		225/225 (100.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	1/14 (7.14%)	2	21/221 (9.50%)	49	10/225 (4.44%)	15
Neutropenia ^† 1	2/14 (14.29%)	4	3/221 (1.36%)	9	2/225 (0.89%)	11
Thrombocytopenia ^† 1	1/14 (7.14%)	6	5/221 (2.26%)	9	0/225 (0.00%)	0
Cardiac disorders
Sinus bradycardia ^† 1	1/14 (7.14%)	1	2/221 (0.90%)	3	1/225 (0.44%)	1
Ear and labyrinth disorders
Vertigo ^† 1	0/14 (0.00%)	0	12/221 (5.43%)	16	4/225 (1.78%)	5
Endocrine disorders
Hypothyroidism ^† 1	1/14 (7.14%)	1	3/221 (1.36%)	3	0/225 (0.00%)	0
Eye disorders
Blepharitis ^† 1	1/14 (7.14%)	1	4/221 (1.81%)	7	9/225 (4.00%)	11
Dry eye ^† 1	1/14 (7.14%)	1	22/221 (9.95%)	27	23/225 (10.22%)	24
Eyelid oedema ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Ocular discomfort ^† 1	1/14 (7.14%)	2	0/221 (0.00%)	0	1/225 (0.44%)	1
Ocular hyperaemia ^† 1	1/14 (7.14%)	1	3/221 (1.36%)	3	2/225 (0.89%)	2
Gastrointestinal disorders
Abdominal discomfort ^† 1	1/14 (7.14%)	1	1/221 (0.45%)	1	2/225 (0.89%)	2
Abdominal pain ^† 1	3/14 (21.43%)	5	15/221 (6.79%)	26	15/225 (6.67%)	18
Abdominal pain upper ^† 1	2/14 (14.29%)	2	17/221 (7.69%)	23	19/225 (8.44%)	41
Anal fissure ^† 1	1/14 (7.14%)	1	2/221 (0.90%)	5	1/225 (0.44%)	1
Anal fistula ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Cheilitis ^† 1	1/14 (7.14%)	1	7/221 (3.17%)	8	5/225 (2.22%)	5
Constipation ^† 1	2/14 (14.29%)	3	42/221 (19.00%)	52	31/225 (13.78%)	38
Dental caries ^† 1	1/14 (7.14%)	1	8/221 (3.62%)	8	8/225 (3.56%)	8
Diarrhoea ^† 1	13/14 (92.86%)	57	154/221 (69.68%)	410	160/225 (71.11%)	388
Dry mouth ^† 1	1/14 (7.14%)	1	8/221 (3.62%)	8	3/225 (1.33%)	5
Dyspepsia ^† 1	1/14 (7.14%)	1	11/221 (4.98%)	17	12/225 (5.33%)	21
Dysphagia ^† 1	1/14 (7.14%)	1	4/221 (1.81%)	6	5/225 (2.22%)	6
Gastritis ^† 1	0/14 (0.00%)	0	19/221 (8.60%)	22	9/225 (4.00%)	11
Gastrooesophageal reflux disease ^† 1	1/14 (7.14%)	1	16/221 (7.24%)	22	9/225 (4.00%)	12
Gingival bleeding ^† 1	2/14 (14.29%)	2	19/221 (8.60%)	23	3/225 (1.33%)	3
Haemorrhoids ^† 1	0/14 (0.00%)	0	14/221 (6.33%)	19	9/225 (4.00%)	12
Inguinal hernia ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Nausea ^† 1	4/14 (28.57%)	5	57/221 (25.79%)	81	44/225 (19.56%)	79
Oesophageal pain ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Rectal haemorrhage ^† 1	2/14 (14.29%)	2	2/221 (0.90%)	2	0/225 (0.00%)	0
Stomatitis ^† 1	6/14 (42.86%)	13	92/221 (41.63%)	148	82/225 (36.44%)	144
Tooth disorder ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Toothache ^† 1	1/14 (7.14%)	1	5/221 (2.26%)	5	1/225 (0.44%)	1
Vomiting ^† 1	4/14 (28.57%)	6	26/221 (11.76%)	34	25/225 (11.11%)	31
General disorders
Asthenia ^† 1	3/14 (21.43%)	11	17/221 (7.69%)	34	14/225 (6.22%)	29
Chest pain ^† 1	2/14 (14.29%)	2	5/221 (2.26%)	5	3/225 (1.33%)	3
Cyst ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	1/225 (0.44%)	1
Fatigue ^† 1	2/14 (14.29%)	10	25/221 (11.31%)	55	27/225 (12.00%)	51
Influenza like illness ^† 1	0/14 (0.00%)	0	5/221 (2.26%)	8	13/225 (5.78%)	17
Malaise ^† 1	0/14 (0.00%)	0	34/221 (15.38%)	69	19/225 (8.44%)	35
Mucosal inflammation ^† 1	2/14 (14.29%)	3	14/221 (6.33%)	28	6/225 (2.67%)	6
Non-cardiac chest pain ^† 1	1/14 (7.14%)	1	10/221 (4.52%)	13	5/225 (2.22%)	5
Oedema ^† 1	2/14 (14.29%)	2	3/221 (1.36%)	4	2/225 (0.89%)	2
Oedema peripheral ^† 1	5/14 (35.71%)	6	50/221 (22.62%)	78	10/225 (4.44%)	11
Pain ^† 1	1/14 (7.14%)	1	6/221 (2.71%)	6	9/225 (4.00%)	10
Pyrexia ^† 1	3/14 (21.43%)	4	45/221 (20.36%)	57	24/225 (10.67%)	34
Xerosis ^† 1	1/14 (7.14%)	1	7/221 (3.17%)	9	4/225 (1.78%)	5
Hepatobiliary disorders
Hepatitis ^† 1	1/14 (7.14%)	1	2/221 (0.90%)	6	0/225 (0.00%)	0
Immune system disorders
Allergy to arthropod sting ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Hypersensitivity ^† 1	1/14 (7.14%)	1	1/221 (0.45%)	1	2/225 (0.89%)	2
Infections and infestations
Angular cheilitis ^† 1	1/14 (7.14%)	1	3/221 (1.36%)	3	6/225 (2.67%)	7
Bacteriuria ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Candida infection ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Conjunctivitis ^† 1	2/14 (14.29%)	6	21/221 (9.50%)	26	32/225 (14.22%)	40
Cystitis ^† 1	1/14 (7.14%)	1	8/221 (3.62%)	12	9/225 (4.00%)	17
Eye infection ^† 1	1/14 (7.14%)	1	2/221 (0.90%)	2	0/225 (0.00%)	0
Folliculitis ^† 1	1/14 (7.14%)	1	7/221 (3.17%)	17	11/225 (4.89%)	15
Gastroenteritis ^† 1	1/14 (7.14%)	1	5/221 (2.26%)	5	4/225 (1.78%)	4
Gingivitis ^† 1	1/14 (7.14%)	1	6/221 (2.71%)	16	1/225 (0.44%)	1
Infection ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Nasopharyngitis ^† 1	5/14 (35.71%)	6	22/221 (9.95%)	27	18/225 (8.00%)	28
Paronychia ^† 1	10/14 (71.43%)	24	118/221 (53.39%)	277	114/225 (50.67%)	238
Parotitis ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Perichondritis ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	1/225 (0.44%)	1
Pharyngitis ^† 1	1/14 (7.14%)	1	15/221 (6.79%)	20	6/225 (2.67%)	7
Pulpitis dental ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Rash pustular ^† 1	0/14 (0.00%)	0	6/221 (2.71%)	12	14/225 (6.22%)	34
Respiratory tract infection ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	1/225 (0.44%)	1
Rhinitis ^† 1	1/14 (7.14%)	1	4/221 (1.81%)	4	4/225 (1.78%)	4
Tinea cruris ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Tonsillitis ^† 1	1/14 (7.14%)	1	2/221 (0.90%)	3	1/225 (0.44%)	1
Upper respiratory tract infection ^† 1	2/14 (14.29%)	5	38/221 (17.19%)	53	34/225 (15.11%)	52
Urinary tract infection ^† 1	2/14 (14.29%)	3	17/221 (7.69%)	23	11/225 (4.89%)	21
Injury, poisoning and procedural complications
Fall ^† 1	1/14 (7.14%)	1	2/221 (0.90%)	2	6/225 (2.67%)	6
Infusion related reaction ^† 1	1/14 (7.14%)	1	3/221 (1.36%)	3	2/225 (0.89%)	2
Skin abrasion ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	1/225 (0.44%)	1
Skin laceration ^† 1	1/14 (7.14%)	1	1/221 (0.45%)	1	2/225 (0.89%)	2
Investigations
Alanine aminotransferase increased ^† 1	7/14 (50.00%)	12	93/221 (42.08%)	270	70/225 (31.11%)	192
Aspartate aminotransferase increased ^† 1	5/14 (35.71%)	7	92/221 (41.63%)	270	58/225 (25.78%)	128
Blood alkaline phosphatase increased ^† 1	2/14 (14.29%)	2	23/221 (10.41%)	39	20/225 (8.89%)	46
Blood bilirubin increased ^† 1	3/14 (21.43%)	4	68/221 (30.77%)	254	70/225 (31.11%)	251
Blood creatinine increased ^† 1	1/14 (7.14%)	1	5/221 (2.26%)	13	6/225 (2.67%)	8
Blood lactate dehydrogenase increased ^† 1	1/14 (7.14%)	1	6/221 (2.71%)	22	2/225 (0.89%)	11
Electrocardiogram qt prolonged ^† 1	1/14 (7.14%)	2	3/221 (1.36%)	6	4/225 (1.78%)	5
Gamma-glutamyltransferase increased ^† 1	1/14 (7.14%)	2	12/221 (5.43%)	35	7/225 (3.11%)	11
Neutrophil count decreased ^† 1	1/14 (7.14%)	1	25/221 (11.31%)	83	16/225 (7.11%)	39
Platelet count decreased ^† 1	3/14 (21.43%)	5	31/221 (14.03%)	54	6/225 (2.67%)	10
Transaminases increased ^† 1	1/14 (7.14%)	1	2/221 (0.90%)	5	1/225 (0.44%)	1
Weight decreased ^† 1	1/14 (7.14%)	2	28/221 (12.67%)	54	29/225 (12.89%)	37
White blood cell count decreased ^† 1	0/14 (0.00%)	0	14/221 (6.33%)	53	7/225 (3.11%)	14
Metabolism and nutrition disorders
Decreased appetite ^† 1	4/14 (28.57%)	11	57/221 (25.79%)	101	47/225 (20.89%)	84
Hypoalbuminaemia ^† 1	1/14 (7.14%)	1	14/221 (6.33%)	27	10/225 (4.44%)	17
Hypokalaemia ^† 1	0/14 (0.00%)	0	18/221 (8.14%)	38	5/225 (2.22%)	12
Hypomagnesaemia ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	2/225 (0.89%)	4
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	5/14 (35.71%)	6	8/221 (3.62%)	9	7/225 (3.11%)	7
Back pain ^† 1	4/14 (28.57%)	6	24/221 (10.86%)	28	17/225 (7.56%)	22
Muscle spasms ^† 1	1/14 (7.14%)	1	9/221 (4.07%)	12	8/225 (3.56%)	11
Musculoskeletal chest pain ^† 1	1/14 (7.14%)	1	7/221 (3.17%)	8	12/225 (5.33%)	15
Musculoskeletal discomfort ^† 1	1/14 (7.14%)	2	1/221 (0.45%)	1	0/225 (0.00%)	0
Musculoskeletal pain ^† 1	4/14 (28.57%)	5	12/221 (5.43%)	14	5/225 (2.22%)	5
Myalgia ^† 1	1/14 (7.14%)	1	5/221 (2.26%)	10	9/225 (4.00%)	9
Neck pain ^† 1	3/14 (21.43%)	3	6/221 (2.71%)	8	6/225 (2.67%)	7
Pain in extremity ^† 1	2/14 (14.29%)	2	9/221 (4.07%)	9	12/225 (5.33%)	16
Tendonitis ^† 1	1/14 (7.14%)	1	1/221 (0.45%)	1	0/225 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain ^† 1	1/14 (7.14%)	1	1/221 (0.45%)	1	4/225 (1.78%)	5
Pyogenic granuloma ^† 1	2/14 (14.29%)	2	4/221 (1.81%)	6	0/225 (0.00%)	0
Nervous system disorders
Dizziness ^† 1	1/14 (7.14%)	1	20/221 (9.05%)	27	19/225 (8.44%)	24
Dysgeusia ^† 1	3/14 (21.43%)	3	39/221 (17.65%)	46	32/225 (14.22%)	44
Headache ^† 1	7/14 (50.00%)	13	33/221 (14.93%)	56	16/225 (7.11%)	21
Neuralgia ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	2/225 (0.89%)	2
Paraesthesia ^† 1	1/14 (7.14%)	1	2/221 (0.90%)	3	5/225 (2.22%)	5
Peripheral sensory neuropathy ^† 1	1/14 (7.14%)	1	7/221 (3.17%)	7	9/225 (4.00%)	10
Psychiatric disorders
Anxiety ^† 1	1/14 (7.14%)	1	7/221 (3.17%)	16	4/225 (1.78%)	5
Confusional state ^† 1	1/14 (7.14%)	1	2/221 (0.90%)	3	0/225 (0.00%)	0
Depressed mood ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	1/225 (0.44%)	1
Depression ^† 1	1/14 (7.14%)	2	2/221 (0.90%)	2	4/225 (1.78%)	5
Insomnia ^† 1	3/14 (21.43%)	3	32/221 (14.48%)	36	29/225 (12.89%)	33
Renal and urinary disorders
Haematuria ^† 1	1/14 (7.14%)	2	10/221 (4.52%)	11	8/225 (3.56%)	12
Leukocyturia ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Proteinuria ^† 1	5/14 (35.71%)	18	75/221 (33.94%)	278	19/225 (8.44%)	35
Reproductive system and breast disorders
Genital rash ^† 1	1/14 (7.14%)	2	1/221 (0.45%)	2	0/225 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	3/14 (21.43%)	10	48/221 (21.72%)	62	35/225 (15.56%)	49
Dysphonia ^† 1	2/14 (14.29%)	2	14/221 (6.33%)	17	2/225 (0.89%)	2
Dyspnoea ^† 1	3/14 (21.43%)	3	18/221 (8.14%)	25	9/225 (4.00%)	9
Epistaxis ^† 1	5/14 (35.71%)	5	74/221 (33.48%)	102	27/225 (12.00%)	33
Haemoptysis ^† 1	3/14 (21.43%)	4	11/221 (4.98%)	19	2/225 (0.89%)	2
Interstitial lung disease ^† 1	1/14 (7.14%)	1	1/221 (0.45%)	1	2/225 (0.89%)	2
Nasal disorder ^† 1	1/14 (7.14%)	1	1/221 (0.45%)	1	0/225 (0.00%)	0
Nasal inflammation ^† 1	2/14 (14.29%)	4	4/221 (1.81%)	5	4/225 (1.78%)	5
Oropharyngeal pain ^† 1	1/14 (7.14%)	1	19/221 (8.60%)	25	13/225 (5.78%)	14
Orthopnoea ^† 1	1/14 (7.14%)	1	1/221 (0.45%)	1	0/225 (0.00%)	0
Productive cough ^† 1	0/14 (0.00%)	0	15/221 (6.79%)	21	11/225 (4.89%)	17
Rhinorrhoea ^† 1	1/14 (7.14%)	1	13/221 (5.88%)	17	9/225 (4.00%)	9
Skin and subcutaneous tissue disorders
Alopecia ^† 1	6/14 (42.86%)	7	75/221 (33.94%)	84	44/225 (19.56%)	47
Dermatitis acneiform ^† 1	9/14 (64.29%)	33	149/221 (67.42%)	433	153/225 (68.00%)	447
Dermatitis contact ^† 1	1/14 (7.14%)	1	4/221 (1.81%)	5	6/225 (2.67%)	10
Dry skin ^† 1	9/14 (64.29%)	19	83/221 (37.56%)	127	91/225 (40.44%)	181
Ecchymosis ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Erythema ^† 1	1/14 (7.14%)	2	12/221 (5.43%)	83	10/225 (4.44%)	24
Hair disorder ^† 1	1/14 (7.14%)	1	2/221 (0.90%)	2	1/225 (0.44%)	1
Hirsutism ^† 1	1/11 (9.09%)	1	1/139 (0.72%)	1	4/142 (2.82%)	4
Intertrigo ^† 1	1/14 (7.14%)	1	1/221 (0.45%)	1	0/225 (0.00%)	0
Nail dystrophy ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	3/225 (1.33%)	3
Nail toxicity ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	2/225 (0.89%)	2
Pruritus ^† 1	5/14 (35.71%)	12	51/221 (23.08%)	110	66/225 (29.33%)	165
Purpura ^† 1	2/14 (14.29%)	2	11/221 (4.98%)	17	5/225 (2.22%)	5
Rash ^† 1	5/14 (35.71%)	29	39/221 (17.65%)	103	54/225 (24.00%)	148
Rash macular ^† 1	1/14 (7.14%)	1	1/221 (0.45%)	1	1/225 (0.44%)	1
Rash maculo-papular ^† 1	4/14 (28.57%)	13	20/221 (9.05%)	47	21/225 (9.33%)	53
Skin fissures ^† 1	2/14 (14.29%)	2	9/221 (4.07%)	13	14/225 (6.22%)	19
Skin lesion ^† 1	1/14 (7.14%)	2	2/221 (0.90%)	4	2/225 (0.89%)	4
Xeroderma ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	1/225 (0.44%)	1
Surgical and medical procedures
Dental care ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Dental operation ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Inguinal hernia repair ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Tooth extraction ^† 1	1/14 (7.14%)	1	2/221 (0.90%)	3	3/225 (1.33%)	3
Vaginal pessary insertion ^† 1	1/11 (9.09%)	1	0/139 (0.00%)	0	0/142 (0.00%)	0
Vascular disorders
Hypertension ^† 1	7/14 (50.00%)	27	100/221 (45.25%)	246	27/225 (12.00%)	72
Thrombosis ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
Varicose ulceration ^† 1	1/14 (7.14%)	1	0/221 (0.00%)	0	0/225 (0.00%)	0
1 Term from vocabulary, MedDRA 21.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Chief Medical Officer
Organization:	Eli Lilly and Company
Phone:	800-545-5979
EMail:	ClinicalTrials.gov@lilly.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nakagawa K, Garon EB, Gao L, Callies S, Zimmermann A, Walgren R, Visseren-Grul C, Reck M. RELAY, ramucirumab plus erlotinib versus placebo plus erlotinib in untreated EGFR-mutated metastatic non-small cell lung cancer: exposure-response relationship. Cancer Chemother Pharmacol. 2022 Aug;90(2):137-148. doi: 10.1007/s00280-022-04447-x. Epub 2022 Jul 16.

Nishio M, Nishio K, Reck M, Garon EB, Imamura F, Kawaguchi T, Yamaguchi H, Ikeda S, Hirano K, Visseren-Grul C, Ceccarelli M, Wijayawardana SR, Zimmermann A, Matsui T, Enatsu S, Nakagawa K. RELAY+: Exploratory Study of Ramucirumab Plus Gefitinib in Untreated Patients With EGFR-Mutated Metastatic NSCLC. JTO Clin Res Rep. 2022 Feb 26;3(4):100303. doi: 10.1016/j.jtocrr.2022.100303. eCollection 2022 Apr.

Nadal E, Horinouchi H, Shih JY, Nakagawa K, Reck M, Garon EB, Wei YF, Kollmeier J, Frimodt-Moller B, Barrett E, Lipkovich O, Visseren-Grul C, Novello S. RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile and Manageability. Drug Saf. 2022 Jan;45(1):45-64. doi: 10.1007/s40264-021-01127-2. Epub 2021 Dec 20.

Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

Nakagawa K, Garon EB, Seto T, Nishio M, Ponce Aix S, Paz-Ares L, Chiu CH, Park K, Novello S, Nadal E, Imamura F, Yoh K, Shih JY, Au KH, Moro-Sibilot D, Enatsu S, Zimmermann A, Frimodt-Moller B, Visseren-Grul C, Reck M; RELAY Study Investigators. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Dec;20(12):1655-1669. doi: 10.1016/S1470-2045(19)30634-5. Epub 2019 Oct 4.

Reck M, Garon EB, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Kiura K, Widau RC, He S, Dalal R, Lee P, Nakagawa K. Randomized, Double-Blind Phase Ib/III Study of Erlotinib With Ramucirumab or Placebo in Previously Untreated EGFR-Mutant Metastatic Non-Small-Cell Lung Cancer (RELAY): Phase Ib Results. Clin Lung Cancer. 2018 May;19(3):213-220.e4. doi: 10.1016/j.cllc.2017.11.003. Epub 2017 Nov 21.

Garon EB, Reck M, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Lee P, Dalal R, Liu J, He S, Treat J, Nakagawa K. Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-Blind Study of Erlotinib With Ramucirumab or Placebo in Patients With Epidermal Growth Factor Receptor Mutation-Positive Metastatic Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2017 Jan;18(1):96-99. doi: 10.1016/j.cllc.2016.05.023. Epub 2016 Jun 8.

Layout table for additonal information

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT02411448
Other Study ID Numbers:	15540 I4T-MC-JVCY ( Other Identifier: Eli Lilly and Company ) 2014-004824-22 ( EudraCT Number )
First Submitted:	April 3, 2015
First Posted:	April 8, 2015
Results First Submitted:	January 17, 2020
Results First Posted:	March 4, 2020
Last Update Posted:	March 18, 2024

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