NCT02411448 · OUTCOME
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS)
A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) · Source last updated 2026-01-16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- millimeter
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, End of Study (Up To 37 Months)
What was measured
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).
Analysis 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.
Groups in this outcome
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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 224 |
|---|
| Part B: Placebo+ Erlotinib | 225 |
|---|
Reported measurements
Loss of Appetite
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 213 |
|---|
| Part B: Placebo+ Erlotinib | 217 |
|---|
Values in millimeter · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Ramucirumab+ Erlotinib | -17.07 | 0.92 | Not reported | Not reported | Not reported |
|---|
| Part B: Placebo+ Erlotinib | -18.16 | 0.91 | Not reported | Not reported | Not reported |
|---|
Fatigue
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 213 |
|---|
| Part B: Placebo+ Erlotinib | 217 |
|---|
Values in millimeter · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Ramucirumab+ Erlotinib | -19.35 | 0.91 | Not reported | Not reported | Not reported |
|---|
| Part B: Placebo+ Erlotinib | -19.45 | 0.90 | Not reported | Not reported | Not reported |
|---|
Cough
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 213 |
|---|
| Part B: Placebo+ Erlotinib | 217 |
|---|
Values in millimeter · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Ramucirumab+ Erlotinib | -21.22 | 0.58 | Not reported | Not reported | Not reported |
|---|
| Part B: Placebo+ Erlotinib | -22.09 | 0.57 | Not reported | Not reported | Not reported |
|---|
Shortness of Breath
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 213 |
|---|
| Part B: Placebo+ Erlotinib | 217 |
|---|
Values in millimeter · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Ramucirumab+ Erlotinib | -14.46 | 0.57 | Not reported | Not reported | Not reported |
|---|
| Part B: Placebo+ Erlotinib | -15.93 | 0.57 | Not reported | Not reported | Not reported |
|---|
Blood in Sputum
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 213 |
|---|
| Part B: Placebo+ Erlotinib | 216 |
|---|
Values in millimeter · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Ramucirumab+ Erlotinib | -1.58 | 0.25 | Not reported | Not reported | Not reported |
|---|
| Part B: Placebo+ Erlotinib | -1.94 | 0.25 | Not reported | Not reported | Not reported |
|---|
Pain
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 213 |
|---|
| Part B: Placebo+ Erlotinib | 216 |
|---|
Values in millimeter · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Ramucirumab+ Erlotinib | -13.57 | 0.59 | Not reported | Not reported | Not reported |
|---|
| Part B: Placebo+ Erlotinib | -14.69 | 0.59 | Not reported | Not reported | Not reported |
|---|
Symptom distress
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 213 |
|---|
| Part B: Placebo+ Erlotinib | 217 |
|---|
Values in millimeter · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Ramucirumab+ Erlotinib | -15.91 | 0.67 | Not reported | Not reported | Not reported |
|---|
| Part B: Placebo+ Erlotinib | -16.15 | 0.67 | Not reported | Not reported | Not reported |
|---|
Interference with Activity Level
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 213 |
|---|
| Part B: Placebo+ Erlotinib | 217 |
|---|
Values in millimeter · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Ramucirumab+ Erlotinib | -14.43 | 0.83 | Not reported | Not reported | Not reported |
|---|
| Part B: Placebo+ Erlotinib | -15.60 | 0.82 | Not reported | Not reported | Not reported |
|---|
Global Quality of Life
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 213 |
|---|
| Part B: Placebo+ Erlotinib | 217 |
|---|
Values in millimeter · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Ramucirumab+ Erlotinib | -16.21 | 0.95 | Not reported | Not reported | Not reported |
|---|
| Part B: Placebo+ Erlotinib | -18.12 | 0.94 | Not reported | Not reported | Not reported |
|---|
Average Symptom Burden Index
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 213 |
|---|
| Part B: Placebo+ Erlotinib | 216 |
|---|
Values in millimeter · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Ramucirumab+ Erlotinib | -12.17 | 0.57 | Not reported | Not reported | Not reported |
|---|
| Part B: Placebo+ Erlotinib | -13.05 | 0.57 | Not reported | Not reported | Not reported |
|---|
Total LCSS
Analysis denominator · Participants
| Group | Source count |
|---|
| Part B: Ramucirumab+ Erlotinib | 213 |
|---|
| Part B: Placebo+ Erlotinib | 216 |
|---|
Values in millimeter · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B: Ramucirumab+ Erlotinib | -12.00 | 0.62 | Not reported | Not reported | Not reported |
|---|
| Part B: Placebo+ Erlotinib | -12.71 | 0.61 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.92
- value
- -17.07
- group Id
- OG001
- spread
- 0.91
- value
- -18.16
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 217
- units
- Participants
- title
- Loss of Appetite
- categories
- measurements
- group Id
- OG000
- spread
- 0.91
- value
- -19.35
- group Id
- OG001
- spread
- 0.90
- value
- -19.45
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 217
- units
- Participants
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- spread
- 0.58
- value
- -21.22
- group Id
- OG001
- spread
- 0.57
- value
- -22.09
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 217
- units
- Participants
- title
- Cough
- categories
- measurements
- group Id
- OG000
- spread
- 0.57
- value
- -14.46
- group Id
- OG001
- spread
- 0.57
- value
- -15.93
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 217
- units
- Participants
- title
- Shortness of Breath
- categories
- measurements
- group Id
- OG000
- spread
- 0.25
- value
- -1.58
- group Id
- OG001
- spread
- 0.25
- value
- -1.94
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 216
- units
- Participants
- title
- Blood in Sputum
- categories
- measurements
- group Id
- OG000
- spread
- 0.59
- value
- -13.57
- group Id
- OG001
- spread
- 0.59
- value
- -14.69
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 216
- units
- Participants
- title
- Pain
- categories
- measurements
- group Id
- OG000
- spread
- 0.67
- value
- -15.91
- group Id
- OG001
- spread
- 0.67
- value
- -16.15
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 217
- units
- Participants
- title
- Symptom distress
- categories
- measurements
- group Id
- OG000
- spread
- 0.83
- value
- -14.43
- group Id
- OG001
- spread
- 0.82
- value
- -15.60
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 217
- units
- Participants
- title
- Interference with Activity Level
- categories
- measurements
- group Id
- OG000
- spread
- 0.95
- value
- -16.21
- group Id
- OG001
- spread
- 0.94
- value
- -18.12
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 217
- units
- Participants
- title
- Global Quality of Life
- categories
- measurements
- group Id
- OG000
- spread
- 0.57
- value
- -12.17
- group Id
- OG001
- spread
- 0.57
- value
- -13.05
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 216
- units
- Participants
- title
- Average Symptom Burden Index
- categories
- measurements
- group Id
- OG000
- spread
- 0.62
- value
- -12.00
- group Id
- OG001
- spread
- 0.61
- value
- -12.71
- denoms
- counts
- group Id
- OG000
- value
- 213
- group Id
- OG001
- value
- 216
- units
- Participants
- title
- Total LCSS
- denoms
- counts
- group Id
- OG000
- value
- 224
- group Id
- OG001
- value
- 225
- units
- Participants
- 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).
- dispersion Type
- Standard Error
- groups
- 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.
- id
- OG000
- title
- Part B: Ramucirumab+ Erlotinib
- description
- 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.
- id
- OG001
- title
- Part B: Placebo+ Erlotinib
- param Type
- LEAST_SQUARES_MEAN
- 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.
- reporting Status
- POSTED
- time Frame
- Baseline, End of Study (Up To 37 Months)
- title
- Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS)
- type
- SECONDARY
- unit Of Measure
- millimeter
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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