NCT03052608 · OUTCOME
Change From Baseline in Lung Cancer Symptoms as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) During Overall Treatment
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC · Source last updated 2025-11-25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Units on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Baseline up to Cycle 38 Day 1
What was measured
The EORTC QLQ LC13 consists of 13 questions and includes 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, haemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The scale scores rang from 0 to 100, with higher scores indicating higher ("worse") level of symptoms.
Analysis population: Participants from the FA population who completed a baseline (last patient-reported outcome (PRO) assessment prior to the first dose of study treatment) and at least 1 post-baseline PRO assessment.
Groups in this outcome
Lorlatinib
Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
Crizotinib
Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
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 |
|---|
| Lorlatinib | 146 |
|---|
| Crizotinib | 139 |
|---|
Reported measurements
Dyspnoea
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | -4.36 | Not reported | -6.55 | -2.17 | Not reported |
|---|
| Crizotinib | -4.90 | Not reported | -7.34 | -2.47 | Not reported |
|---|
Coughing
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | -21.21 | Not reported | -23.71 | -18.70 | Not reported |
|---|
| Crizotinib | -16.66 | Not reported | -19.48 | -13.84 | Not reported |
|---|
Haemoptysis
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | -2.53 | Not reported | -3.12 | -1.94 | Not reported |
|---|
| Crizotinib | -2.65 | Not reported | -3.34 | -1.97 | Not reported |
|---|
Sore Mouth
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 0.56 | Not reported | -0.98 | 2.10 | Not reported |
|---|
| Crizotinib | -0.60 | Not reported | -2.39 | 1.19 | Not reported |
|---|
Dysphagia
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | -1.35 | Not reported | -2.95 | 0.25 | Not reported |
|---|
| Crizotinib | 0.16 | Not reported | -1.68 | 2.00 | Not reported |
|---|
Peripheral Neuropathy
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 11.56 | Not reported | 8.21 | 14.91 | Not reported |
|---|
| Crizotinib | 6.20 | Not reported | 2.39 | 10.00 | Not reported |
|---|
Alopecia
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 1.61 | Not reported | -0.97 | 4.20 | Not reported |
|---|
| Crizotinib | 1.81 | Not reported | -1.08 | 4.70 | Not reported |
|---|
Pain in Chest
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | -9.54 | Not reported | -11.27 | -7.80 | Not reported |
|---|
| Crizotinib | -9.01 | Not reported | -10.97 | -7.05 | Not reported |
|---|
Pain in Arm or Shoulder
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | -6.93 | Not reported | -9.43 | -4.43 | Not reported |
|---|
| Crizotinib | -7.38 | Not reported | -10.24 | -4.52 | Not reported |
|---|
Pain in Other Parts
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | -2.31 | Not reported | -5.28 | 0.66 | Not reported |
|---|
| Crizotinib | -5.67 | Not reported | -8.97 | -2.38 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -2.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.60
- group Description
- This is the analysis for QLQ-LC13 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7254
- param Type
- Mean Difference (Net)
- param Value
- 0.55
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -8.06
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.03
- group Description
- This is the analysis for QLQ-LC13 Coughing. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0115
- param Type
- Mean Difference (Net)
- param Value
- -4.55
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -0.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.99
- group Description
- This is the analysis for QLQ-LC13 Haemoptysis. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7824
- param Type
- Mean Difference (Net)
- param Value
- 0.12
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -1.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.36
- group Description
- This is the analysis for QLQ-LC13 Sore Mouth. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2988
- param Type
- Mean Difference (Net)
- param Value
- 1.16
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -3.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.76
- group Description
- This is the analysis for QLQ-LC13 Dysphagia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1916
- param Type
- Mean Difference (Net)
- param Value
- -1.51
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.15
- group Description
- This is the analysis for QLQ-LC13 Peripheral Neuropathy. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0279
- param Type
- Mean Difference (Net)
- param Value
- 5.37
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -3.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.49
- group Description
- This is the analysis for QLQ-LC13 Alopecia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9162
- param Type
- Mean Difference (Net)
- param Value
- -0.20
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -2.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.90
- group Description
- This is the analysis for QLQ-LC13 Pain in Chest. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.6698
- param Type
- Mean Difference (Net)
- param Value
- -0.53
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -3.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.04
- group Description
- This is the analysis for QLQ-LC13 Pain in Arm or Shoulder. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8035
- param Type
- Mean Difference (Net)
- param Value
- 0.45
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -0.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.55
- group Description
- This is the analysis for QLQ-LC13 Pain in Other Parts. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1143
- param Type
- Mean Difference (Net)
- param Value
- 3.36
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -2.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.60
- group Description
- This is the analysis for QLQ-LC13 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7254
- param Type
- Mean Difference (Net)
- param Value
- 0.55
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -8.06
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.03
- group Description
- This is the analysis for QLQ-LC13 Coughing. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0115
- param Type
- Mean Difference (Net)
- param Value
- -4.55
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -0.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.99
- group Description
- This is the analysis for QLQ-LC13 Haemoptysis. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7824
- param Type
- Mean Difference (Net)
- param Value
- 0.12
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -1.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.36
- group Description
- This is the analysis for QLQ-LC13 Sore Mouth. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2988
- param Type
- Mean Difference (Net)
- param Value
- 1.16
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -3.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.76
- group Description
- This is the analysis for QLQ-LC13 Dysphagia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1916
- param Type
- Mean Difference (Net)
- param Value
- -1.51
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.15
- group Description
- This is the analysis for QLQ-LC13 Peripheral Neuropathy. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0279
- param Type
- Mean Difference (Net)
- param Value
- 5.37
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -3.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.49
- group Description
- This is the analysis for QLQ-LC13 Alopecia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9162
- param Type
- Mean Difference (Net)
- param Value
- -0.20
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -2.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.90
- group Description
- This is the analysis for QLQ-LC13 Pain in Chest. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.6698
- param Type
- Mean Difference (Net)
- param Value
- -0.53
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -3.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.04
- group Description
- This is the analysis for QLQ-LC13 Pain in Arm or Shoulder. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8035
- param Type
- Mean Difference (Net)
- param Value
- 0.45
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -0.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.55
- group Description
- This is the analysis for QLQ-LC13 Pain in Other Parts. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1143
- param Type
- Mean Difference (Net)
- param Value
- 3.36
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -6.55
- upper Limit
- -2.17
- value
- -4.36
- group Id
- OG001
- lower Limit
- -7.34
- upper Limit
- -2.47
- value
- -4.90
- title
- Dyspnoea
- categories
- measurements
- group Id
- OG000
- lower Limit
- -23.71
- upper Limit
- -18.70
- value
- -21.21
- group Id
- OG001
- lower Limit
- -19.48
- upper Limit
- -13.84
- value
- -16.66
- title
- Coughing
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.12
- upper Limit
- -1.94
- value
- -2.53
- group Id
- OG001
- lower Limit
- -3.34
- upper Limit
- -1.97
- value
- -2.65
- title
- Haemoptysis
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.98
- upper Limit
- 2.10
- value
- 0.56
- group Id
- OG001
- lower Limit
- -2.39
- upper Limit
- 1.19
- value
- -0.60
- title
- Sore Mouth
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.95
- upper Limit
- 0.25
- value
- -1.35
- group Id
- OG001
- lower Limit
- -1.68
- upper Limit
- 2.00
- value
- 0.16
- title
- Dysphagia
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.21
- upper Limit
- 14.91
- value
- 11.56
- group Id
- OG001
- lower Limit
- 2.39
- upper Limit
- 10.00
- value
- 6.20
- title
- Peripheral Neuropathy
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.97
- upper Limit
- 4.20
- value
- 1.61
- group Id
- OG001
- lower Limit
- -1.08
- upper Limit
- 4.70
- value
- 1.81
- title
- Alopecia
- categories
- measurements
- group Id
- OG000
- lower Limit
- -11.27
- upper Limit
- -7.80
- value
- -9.54
- group Id
- OG001
- lower Limit
- -10.97
- upper Limit
- -7.05
- value
- -9.01
- title
- Pain in Chest
- categories
- measurements
- group Id
- OG000
- lower Limit
- -9.43
- upper Limit
- -4.43
- value
- -6.93
- group Id
- OG001
- lower Limit
- -10.24
- upper Limit
- -4.52
- value
- -7.38
- title
- Pain in Arm or Shoulder
- categories
- measurements
- group Id
- OG000
- lower Limit
- -5.28
- upper Limit
- 0.66
- value
- -2.31
- group Id
- OG001
- lower Limit
- -8.97
- upper Limit
- -2.38
- value
- -5.67
- title
- Pain in Other Parts
- denoms
- counts
- group Id
- OG000
- value
- 146
- group Id
- OG001
- value
- 139
- units
- Participants
- description
- The EORTC QLQ LC13 consists of 13 questions and includes 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, haemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The scale scores rang from 0 to 100, with higher scores indicating higher ("worse") level of symptoms.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- id
- OG000
- title
- Lorlatinib
- description
- Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- id
- OG001
- title
- Crizotinib
- param Type
- MEAN
- population Description
- Participants from the FA population who completed a baseline (last patient-reported outcome (PRO) assessment prior to the first dose of study treatment) and at least 1 post-baseline PRO assessment.
- reporting Status
- POSTED
- time Frame
- From Baseline up to Cycle 38 Day 1
- title
- Change From Baseline in Lung Cancer Symptoms as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) During Overall Treatment
- type
- SECONDARY
- unit Of Measure
- Units on a scale
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Preserved source evidence · Not medical advice
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