LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Randomized Set (RS): All patients who were randomized, regardless of whether they received investigational treatment.

→

secondary · POSTED

Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint.

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secondary · POSTED

A patient with a best overall response of Complete Responder (CR) or Partial Responder (PR) was considered to show objective response to study medication. For patients with an objective response, time to objective response was defined as the time from randomization to the first objective response; duration of objective response was defined as the time from the first objective response to progression (or death if the patient died before progression). Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

→

secondary · POSTED

Disease control was assessed based on Independent Radiologic Review (IRR) and investigator assessment. A patient with a best overall response of CR, PR, or Stable Disease (SD) was considered to have disease control. Patients with no baseline target lesions who had no evidence of disease progression in their non-target lesions and had no new lesions were considered to have disease control. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

→

secondary · POSTED

Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review. The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation. A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size. Post-baseline mean is adjusted for baseline sum of diameters and race.

Patients from the randomised set with tumour assessments are considered for the analysis of this endpoint.

→

secondary · POSTED

Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id: NCT01523587
qol key: qol-0005
source section id: NCT01523587-om-0005
source outcome index: 5
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire
measure definition: Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time.
time frame: From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: RS
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id: NCT01523587
qol key: qol-0006
source section id: NCT01523587-om-0006
source outcome index: 6
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.
measure definition: Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration.
time frame: From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: RS
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Change in Score Over Time in Coughing,Dyspnoea and Pain

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id: NCT01523587
qol key: qol-0007
source section id: NCT01523587-om-0007
source outcome index: 7
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Change in Score Over Time in Coughing,Dyspnoea and Pain
measure definition: Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race. Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant. The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table). Post-baseline mean is adjusted for baseline and race.
time frame: From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: RS
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id: NCT01523587
trial label: LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 3

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0000
source section id
NCT01523587-om-0000
source outcome index
0
endpoint
Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1
endpoint definition
Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Randomized Set (RS): All patients who were randomized, regardless of whether they received investigational treatment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0001
source section id
NCT01523587-om-0001
source outcome index
1
endpoint
Overall Survival
endpoint definition
Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint.
time origin
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
RS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0002
source section id
NCT01523587-om-0002
source outcome index
2
endpoint
Number of Participants With Objective Response According to RECIST 1.1
endpoint definition
A patient with a best overall response of Complete Responder (CR) or Partial Responder (PR) was considered to show objective response to study medication. For patients with an objective response, time to objective response was defined as the time from randomization to the first objective response; duration of objective response was defined as the time from the first objective response to progression (or death if the patient died before progression). Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
RS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0003
source section id
NCT01523587-om-0003
source outcome index
3
endpoint
Number of Participants With Disease Control According to RECIST 1.1
endpoint definition
Disease control was assessed based on Independent Radiologic Review (IRR) and investigator assessment. A patient with a best overall response of CR, PR, or Stable Disease (SD) was considered to have disease control. Patients with no baseline target lesions who had no evidence of disease progression in their non-target lesions and had no new lesions were considered to have disease control. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
RS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0004
source section id
NCT01523587-om-0004
source outcome index
4
endpoint
Tumour Shrinkage
endpoint definition
Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review. The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation. A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size. Post-baseline mean is adjusted for baseline sum of diameters and race.
time origin
First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients from the randomised set with tumour assessments are considered for the analysis of this endpoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0005
source section id
NCT01523587-om-0005
source outcome index
5
endpoint
Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire
endpoint definition
Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time.
time origin
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
RS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0000
arm key
OG000
arm label
Afatinib
regimen
Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
analyzed count
398
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0000
arm key
OG001
arm label
Erlotinib
regimen
Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
analyzed count
397
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0001
arm key
OG000
arm label
Afatinib
regimen
Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
analyzed count
398
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0001
arm key
OG001
arm label
Erlotinib
regimen
Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
analyzed count
397
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0002
arm key
OG000
arm label
Afatinib
regimen
Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
analyzed count
398
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0002
arm key
OG001
arm label
Erlotinib
regimen
Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
analyzed count
397
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0003
arm key
OG000
arm label
Afatinib
regimen
Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
analyzed count
398
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0003
arm key
OG001
arm label
Erlotinib
regimen
Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
analyzed count
397
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0004
arm key
OG000
arm label
Afatinib
regimen
Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
analyzed count
307
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0004
arm key
OG001
arm label
Erlotinib
regimen
Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
analyzed count
311
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0005
arm key
OG000
arm label
Afatinib
regimen
Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
analyzed count
398
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
outcome key
om-0005
arm key
OG001
arm label
Erlotinib
regimen
Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
analyzed count
397
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01523587-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
harm key
EG000
source section id
NCT01523587-ae
event group key
EG000
event group label
Afatinib
serious affected
174
serious at risk
392
other affected
383
other at risk
392
frequency threshold
5
collection period
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
event definition
All adverse events (AEs) reported for this trial are on treatment AEs.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
harm key
EG001
source section id
NCT01523587-ae
event group key
EG001
event group label
Erlotinib
serious affected
175
serious at risk
395
other affected
371
other at risk
395
frequency threshold
5
collection period
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
event definition
All adverse events (AEs) reported for this trial are on treatment AEs.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
qol key
qol-0005
source section id
NCT01523587-om-0005
source outcome index
5
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire
measure definition
Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time.
time frame
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
RS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
qol key
qol-0006
source section id
NCT01523587-om-0006
source outcome index
6
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.
measure definition
Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration.
time frame
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
RS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
nct id
NCT01523587
qol key
qol-0007
source section id
NCT01523587-om-0007
source outcome index
7
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change in Score Over Time in Coughing,Dyspnoea and Pain
measure definition
Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race. Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant. The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table). Post-baseline mean is adjusted for baseline and race.
time frame
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
RS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice