Trial Outcomes & Findings for A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) (NCT NCT02411448)

Last Updated: 2026-01-16

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

545 participants

Primary outcome timeframe

Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months)

Results posted on

2026-01-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Part A: Ramucirumab + Erlotinib 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: Ramucirumab+ Erlotinib 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+ Erlotinib 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 Study STARTED	14	224	225
Overall Study Received at Least One Dose of Study Drug	14	221	225
Overall Study COMPLETED	10	141	173
Overall Study NOT COMPLETED	4	83	52

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Ramucirumab + Erlotinib 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: Ramucirumab+ Erlotinib 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+ Erlotinib 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 Study Withdrawal by Subject	1	14	9
Overall Study Other	0	2	0
Overall Study Did not receive study treatment	0	3	0
Overall Study Alive on study treatment	3	64	43

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Ramucirumab + Erlotinib n=14 Participants 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: Ramucirumab+ Erlotinib n=224 Participants 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+ Erlotinib n=225 Participants 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 n=463 Participants Total of all reporting groups
Age, Continuous Part A	67.6 years STANDARD_DEVIATION 13.2 • n=9 Participants	NA years STANDARD_DEVIATION NA • n=6 Participants	NA years STANDARD_DEVIATION NA • n=9 Participants	67.6 years STANDARD_DEVIATION 13 • n=17 Participants
Age, Continuous Part B	NA years STANDARD_DEVIATION NA • n=9 Participants	63.7 years STANDARD_DEVIATION 10.2 • n=6 Participants	62.9 years STANDARD_DEVIATION 10.6 • n=9 Participants	63.3 years STANDARD_DEVIATION 10.4 • n=17 Participants
Sex: Female, Male Female	11 Participants n=9 Participants	141 Participants n=6 Participants	142 Participants n=9 Participants	294 Participants n=17 Participants
Sex: Female, Male Male	3 Participants n=9 Participants	83 Participants n=6 Participants	83 Participants n=9 Participants	169 Participants n=17 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants	13 Participants n=6 Participants	10 Participants n=9 Participants	23 Participants n=17 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=9 Participants	150 Participants n=6 Participants	160 Participants n=9 Participants	311 Participants n=17 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=9 Participants	61 Participants n=6 Participants	55 Participants n=9 Participants	129 Participants n=17 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=6 Participants	1 Participants n=9 Participants	1 Participants n=17 Participants
Race (NIH/OMB) Asian	7 Participants n=9 Participants	172 Participants n=6 Participants	174 Participants n=9 Participants	353 Participants n=17 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=6 Participants	1 Participants n=9 Participants	1 Participants n=17 Participants
Race (NIH/OMB) White	7 Participants n=9 Participants	52 Participants n=6 Participants	48 Participants n=9 Participants	107 Participants n=17 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=6 Participants	1 Participants n=9 Participants	1 Participants n=17 Participants
Region of Enrollment Romania	0 Participants n=9 Participants	2 Participants n=6 Participants	0 Participants n=9 Participants	2 Participants n=17 Participants
Region of Enrollment Hong Kong	0 Participants n=9 Participants	9 Participants n=6 Participants	6 Participants n=9 Participants	15 Participants n=17 Participants
Region of Enrollment United States	0 Participants n=9 Participants	7 Participants n=6 Participants	2 Participants n=9 Participants	9 Participants n=17 Participants
Region of Enrollment Japan	7 Participants n=9 Participants	106 Participants n=6 Participants	105 Participants n=9 Participants	218 Participants n=17 Participants
Region of Enrollment United Kingdom	0 Participants n=9 Participants	4 Participants n=6 Participants	3 Participants n=9 Participants	7 Participants n=17 Participants
Region of Enrollment Spain	7 Participants n=9 Participants	23 Participants n=6 Participants	19 Participants n=9 Participants	49 Participants n=17 Participants
Region of Enrollment Canada	0 Participants n=9 Participants	0 Participants n=6 Participants	2 Participants n=9 Participants	2 Participants n=17 Participants
Region of Enrollment South Korea	0 Participants n=9 Participants	25 Participants n=6 Participants	29 Participants n=9 Participants	54 Participants n=17 Participants
Region of Enrollment Turkey	0 Participants n=9 Participants	3 Participants n=6 Participants	4 Participants n=9 Participants	7 Participants n=17 Participants
Region of Enrollment Taiwan	0 Participants n=9 Participants	26 Participants n=6 Participants	30 Participants n=9 Participants	56 Participants n=17 Participants
Region of Enrollment Italy	0 Participants n=9 Participants	8 Participants n=6 Participants	12 Participants n=9 Participants	20 Participants n=17 Participants
Region of Enrollment France	0 Participants n=9 Participants	4 Participants n=6 Participants	7 Participants n=9 Participants	11 Participants n=17 Participants
Region of Enrollment Germany	0 Participants n=9 Participants	7 Participants n=6 Participants	6 Participants n=9 Participants	13 Participants n=17 Participants
Geographic Region East Asia	7 Participants n=9 Participants	166 Participants n=6 Participants	170 Participants n=9 Participants	343 Participants n=17 Participants
Geographic Region Other*	7 Participants n=9 Participants	58 Participants n=6 Participants	55 Participants n=9 Participants	120 Participants n=17 Participants

PRIMARY outcome

Timeframe: Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months)

Population: 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.

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=224 Participants 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+ Erlotinib n=225 Participants 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.	Part B: Placebo + Erlotinib 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.
Part B: Progression Free Survival (PFS)	19.4 Months Interval 15.4 to 21.6	12.4 Months Interval 11.0 to 13.5	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 through End of Study (Up To 3 Years)

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

A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=14 Participants 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+ Erlotinib n=221 Participants 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.	Part B: Placebo + Erlotinib n=225 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events	14 Participants	221 Participants	225 Participants

SECONDARY outcome

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

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=224 Participants 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+ Erlotinib n=225 Participants 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.	Part B: Placebo + Erlotinib 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.
Part B: Overall Survival (OS)	NA months There were not enough events/deaths to compute a median or 95% confidence interval.	NA months There were not enough events/deaths to compute a median or 95% confidence interval.	—

SECONDARY outcome

Timeframe: Randomization to Progressive Disease (Up To 37 Months)

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

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.

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=224 Participants 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+ Erlotinib n=225 Participants 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.	Part B: Placebo + Erlotinib 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.
Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	76.3 percentage of participants Interval 70.8 to 81.9	74.7 percentage of participants Interval 69.0 to 80.3	—

SECONDARY outcome

Timeframe: Randomization to Progressive Disease (Up To 37 Months)

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

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.

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=224 Participants 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+ Erlotinib n=225 Participants 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.	Part B: Placebo + Erlotinib 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.
Part B: Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])	95.1 percentage of participants Interval 92.3 to 97.9	95.6 percentage of participants Interval 92.9 to 98.2	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=171 Participants 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+ Erlotinib n=168 Participants 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.	Part B: Placebo + Erlotinib 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.
Part B: Duration of Response (DoR)	18.0 months Interval 13.9 to 19.8	11.1 months Interval 9.7 to 12.3	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1: Predose; Cycle 4 Day 1: Predose; Cycle 7 Day 1: Predose; Cycle 14 Day 1

Population: 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.

Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=185 Participants 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+ Erlotinib 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.	Part B: Placebo + Erlotinib 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.
Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab Cycle 14	99.4 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 31	—	—
Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab Cycle 2	39.6 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 32	—	—
Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab Cycle 4	68.5 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 37	—	—
Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab Cycle 7	85.7 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 32	—	—

SECONDARY outcome

Timeframe: Cycle 1 Predose through Follow-up (Up To 37 Months)

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

Part B: Number of Participants With Anti-Ramucirumab Antibodies.

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=221 Participants 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+ Erlotinib n=225 Participants 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.	Part B: Placebo + Erlotinib 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.
Part B: Number of Participants With Anti-Ramucirumab Antibodies	14 Participants	18 Participants	—

SECONDARY outcome

Timeframe: Baseline, End of Study (Up To 37 Months)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=224 Participants 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+ Erlotinib n=225 Participants 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.	Part B: Placebo + Erlotinib 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.
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) Fatigue	-19.35 millimeter Standard Error 0.91	-19.45 millimeter Standard Error 0.90	—
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) Cough	-21.22 millimeter Standard Error 0.58	-22.09 millimeter Standard Error 0.57	—
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) Shortness of Breath	-14.46 millimeter Standard Error 0.57	-15.93 millimeter Standard Error 0.57	—
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) Blood in Sputum	-1.58 millimeter Standard Error 0.25	-1.94 millimeter Standard Error 0.25	—
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) Interference with Activity Level	-14.43 millimeter Standard Error 0.83	-15.60 millimeter Standard Error 0.82	—
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) Global Quality of Life	-16.21 millimeter Standard Error 0.95	-18.12 millimeter Standard Error 0.94	—
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index	-12.17 millimeter Standard Error 0.57	-13.05 millimeter Standard Error 0.57	—
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) Total LCSS	-12.00 millimeter Standard Error 0.62	-12.71 millimeter Standard Error 0.61	—
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) Pain	-13.57 millimeter Standard Error 0.59	-14.69 millimeter Standard Error 0.59	—
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) Symptom distress	-15.91 millimeter Standard Error 0.67	-16.15 millimeter Standard Error 0.67	—
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS) Loss of Appetite	-17.07 millimeter Standard Error 0.92	-18.16 millimeter Standard Error 0.91	—

SECONDARY outcome

Timeframe: Baseline, Cycle 10 (each cycle is 2 weeks)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=170 Participants 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+ Erlotinib n=170 Participants 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.	Part B: Placebo + Erlotinib 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.
Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score	0.02 score on a scale Standard Deviation 0.15	0.02 score on a scale Standard Deviation 0.15	—

SECONDARY outcome

Timeframe: Baseline, Cycle 28 (each cycle is 2 weeks)

Population: 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.

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=108 Participants 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+ Erlotinib n=81 Participants 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.	Part B: Placebo + Erlotinib 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.
Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score	0.02 score on a scale Standard Deviation 0.18	0.01 score on a scale Standard Deviation 0.1	—

SECONDARY outcome

Timeframe: Baseline, Cycle 40 (each cycle is 2 weeks)

Population: 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.

Outcome measures

Outcome measures
Measure	Part B: Ramucirumab+ Erlotinib n=57 Participants 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+ Erlotinib n=44 Participants 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.	Part B: Placebo + Erlotinib 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.
Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score	0.01 score on a scale Standard Deviation 0.15	-0.01 score on a scale Standard Deviation 0.14	—

Adverse Events

Part A: Ramucirumab + Erlotinib

Serious events: 0 serious events

Other events: 14 other events

Deaths: 2 deaths

Part B: Ramucirumab + Erlotinib

Serious events: 65 serious events

Other events: 220 other events

Deaths: 37 deaths

Part B: Placebo + Erlotinib

Serious events: 47 serious events

Other events: 225 other events

Deaths: 42 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