FLAURA

Draft scope assessment: exact. Source null Source null

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 was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS. The primary endpoint of PFS was based on Investigator assessment.

The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.

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primary · POSTED

Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS.

→

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 · Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaires Lung Cancer 13 (QLQ-LC13)

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-egfr-mutated-advanced-nsclc
nct id: NCT02296125
qol key: qol-0011
source section id: NCT02296125-om-0011
source outcome index: 11
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaires Lung Cancer 13 (QLQ-LC13)
measure definition: The EORTC QLQ-LC13 was a lung-cancer-specific module comprising 13 questions to assess lung cancer symptoms (cough, haemoptysis, dyspnoea, and site-specific pain); treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia); and pain medication. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items. Higher scores on the global health status/QoL and functioning scales indicated better health status/QoL and function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure.
time frame: Questionnaires completed at baseline, first 9 months, and at week 1, 2, 3, 4, 5, 6, 12, 18, 24, 30 and 36
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
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 From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30)

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-egfr-mutated-advanced-nsclc
nct id: NCT02296125
qol key: qol-0012
source section id: NCT02296125-om-0012
source outcome index: 12
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30)
measure definition: The EORTC QLQ-C30 cancer-specific questionnaire consisted of 30 questions, combined to produce 5 functional scales, 3 symptom scales, 6 individual items, and a global measure of health status/QoL. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, the functional scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and functioning scales indicated better health status/function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure.
time frame: Questionnaires completed at baseline, first 9 months, and at week 6, 12, 18, 24, 30, and 36.
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
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-egfr-mutated-advanced-nsclc
nct id: NCT02296125
trial label: FLAURA
applicability: exact
applicability note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Source null
outcome Count: 2
harms Count: 4
qol Count: 2

outcomes

release id
clinical-indications-draft-1
disease state id
ds-egfr-mutated-advanced-nsclc
nct id
NCT02296125
outcome key
om-0000
source section id
NCT02296125-om-0000
source outcome index
0
endpoint
Median Progression Free Survival (PFS) (Months)
endpoint definition
Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS. The primary endpoint of PFS was based on Investigator assessment.
time origin
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
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-egfr-mutated-advanced-nsclc
nct id
NCT02296125
outcome key
om-0001
source section id
NCT02296125-om-0001
source outcome index
1
endpoint
Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months
endpoint definition
Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS.
time origin
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
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-egfr-mutated-advanced-nsclc
nct id
NCT02296125
outcome key
om-0000
arm key
OG000
arm label
Osimertinib 80 mg (Global Cohort)
regimen
Randomized participants received Osimertinib 80 mg orally once daily (QD)
analyzed count
279
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02296125-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-egfr-mutated-advanced-nsclc
nct id
NCT02296125
outcome key
om-0000
arm key
OG001
arm label
SoC EGFR-TKI (Global Cohort)
regimen
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
analyzed count
277
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02296125-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-egfr-mutated-advanced-nsclc
nct id
NCT02296125
outcome key
om-0000
arm key
OG002
arm label
Osimertinib 80 mg (China Cohort)
regimen
Randomized participants received Osimertinib 80 mg orally once daily (QD)
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02296125-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-egfr-mutated-advanced-nsclc
nct id
NCT02296125
outcome key
om-0000
arm key
OG003
arm label
SoC EGFR-TKI (China Cohort)
regimen
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
analyzed count
65
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02296125-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-egfr-mutated-advanced-nsclc
nct id
NCT02296125
outcome key
om-0001
arm key
OG000
arm label
Osimertinib 80 mg (Global Cohort)
regimen
Randomized participants received Osimertinib 80 mg orally once daily (QD)
analyzed count
279
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02296125-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-egfr-mutated-advanced-nsclc
nct id
NCT02296125
outcome key
om-0001
arm key
OG001
arm label
SoC EGFR-TKI (Global Cohort)
regimen
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
analyzed count
277
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02296125-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-egfr-mutated-advanced-nsclc
nct id
NCT02296125
outcome key
om-0001
arm key
OG002
arm label
Osimertinib 80 mg (China Cohort)
regimen
Randomized participants received Osimertinib 80 mg orally once daily (QD)
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02296125-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-egfr-mutated-advanced-nsclc
nct id
NCT02296125
outcome key
om-0001
arm key
OG003
arm label
SoC EGFR-TKI (China Cohort)
regimen
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
analyzed count
65
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02296125-om-0001#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-egfr-mutated-advanced-nsclc
nct id
NCT02296125
harm key
EG000
source section id
NCT02296125-ae
event group key
EG000
event group label
Osimertinib 80 mg (Global Cohort)
serious affected
74
serious at risk
279
other affected
273
other at risk
279
frequency threshold
5
collection period
All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued
event definition
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment had been administered. The term AE was used to include both serious and non-serious 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-egfr-mutated-advanced-nsclc
nct id
NCT02296125
harm key
EG001
source section id
NCT02296125-ae
event group key
EG001
event group label
SoC EGFR-TKI (Global Cohort)
serious affected
76
serious at risk
277
other affected
271
other at risk
277
frequency threshold
5
collection period
All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued
event definition
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment had been administered. The term AE was used to include both serious and non-serious 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-egfr-mutated-advanced-nsclc
nct id
NCT02296125
harm key
EG002
source section id
NCT02296125-ae
event group key
EG002
event group label
Osimertinib 80 mg (China Cohort)
serious affected
25
serious at risk
71
other affected
70
other at risk
71
frequency threshold
5
collection period
All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued
event definition
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment had been administered. The term AE was used to include both serious and non-serious 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-egfr-mutated-advanced-nsclc
nct id
NCT02296125
harm key
EG003
source section id
NCT02296125-ae
event group key
EG003
event group label
SoC EGFR-TKI (China Cohort)
serious affected
12
serious at risk
65
other affected
64
other at risk
65
frequency threshold
5
collection period
All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued
event definition
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment had been administered. The term AE was used to include both serious and non-serious 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-egfr-mutated-advanced-nsclc
nct id
NCT02296125
qol key
qol-0011
source section id
NCT02296125-om-0011
source outcome index
11
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaires Lung Cancer 13 (QLQ-LC13)
measure definition
The EORTC QLQ-LC13 was a lung-cancer-specific module comprising 13 questions to assess lung cancer symptoms (cough, haemoptysis, dyspnoea, and site-specific pain); treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia); and pain medication. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items. Higher scores on the global health status/QoL and functioning scales indicated better health status/QoL and function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure.
time frame
Questionnaires completed at baseline, first 9 months, and at week 1, 2, 3, 4, 5, 6, 12, 18, 24, 30 and 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
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-egfr-mutated-advanced-nsclc
nct id
NCT02296125
qol key
qol-0012
source section id
NCT02296125-om-0012
source outcome index
12
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30)
measure definition
The EORTC QLQ-C30 cancer-specific questionnaire consisted of 30 questions, combined to produce 5 functional scales, 3 symptom scales, 6 individual items, and a global measure of health status/QoL. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, the functional scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and functioning scales indicated better health status/function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure.
time frame
Questionnaires completed at baseline, first 9 months, and at week 6, 12, 18, 24, 30, and 36.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

release id
clinical-indications-draft-1
disease state id
ds-egfr-mutated-advanced-nsclc
link id
link-NCT02296125
source collection
registry-study
source key
NCT02296125
relation
primary-publication
relation note
Source null
recorded at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-egfr-mutated-advanced-nsclc
link id
link-NCT04035486
source collection
registry-study
source key
NCT04035486
relation
supporting-publication
relation note
Source null
recorded at
2026-09-10T00:00:00Z

Preserved source evidence · Not medical advice