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NCT01121393 · STUDY IN CONTEXT

BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)

Draft scope assessment: unclear. Attached because the study's own record names EGFR. 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

The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS. Only data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates.

The randomised set (RS) included all patients randomised to receive treatment, whether treated or not.

→

secondary · POSTED

OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR. CR is defined as the disappearance of all target lesions and non-target lesions and no new lesions. PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions. (Exact 95% Confidence interval by Clopper and Pearson.)

The randomised set.

→

secondary · POSTED

DC is defined as a patient with objective response (OR) or stable disease (SD) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with DC.

The randomised set.

→

secondary · POSTED

OS is defined as the time from randomisation to death. For patients who had not died until 7 December 2017, the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date. Median time results from unstratified Kaplan-Meier estimates.

The randomised set.

→

secondary · POSTED

OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1. For patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response. Outcome data are the percentage of patients with OR by each scheduled tumour assessment.

The RS included all patients randomised to receive treatment, whether treated or not.

→

secondary · POSTED

OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1. For patients with an objective response, duration of objective response was defined as the time from the first objective response to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates.

The Randomised set with an objective response.

→

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 · Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing

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-iressa-7aece853
nct id: NCT01121393
qol key: qol-0010
source section id: NCT01121393-om-0010
source outcome index: 10
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing
measure definition: HRQOL as measured by standardised questionnaires (EuropeanOrganisation for Research and Treatment of Cancer (EORTC)) quality of life questionaires (OLQ-C30) and its lung cancer module (QLQ-LC13). Analysis for cough: QLQ-LC13, question 1. Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.
time frame: Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: The randomised set.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea

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-iressa-7aece853
nct id: NCT01121393
qol key: qol-0011
source section id: NCT01121393-om-0011
source outcome index: 11
instrument: EORTC QLQ
instrument basis: matched 'qlq' in the study's own wording
scale title: Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea
measure definition: HRQOL as measured by OLQ-C30 and its lung cancer module (QLQ-LC13). Analysis for dyspnoea: composite of QLQ-LC13, questions 3 to 5; individual item from QLQ-C30, question 8. Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.
time frame: Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: The randomised set.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Health Related Quality of Life (HRQOL): Time of Deterioration in 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-iressa-7aece853
nct id: NCT01121393
qol key: qol-0012
source section id: NCT01121393-om-0012
source outcome index: 12
instrument: EORTC QLQ
instrument basis: matched 'qlq' in the study's own wording
scale title: Health Related Quality of Life (HRQOL): Time of Deterioration in Pain
measure definition: HRQOL as measured by OLQ-C30 and its lung cancer module QLQ-LC13. Analysis for pain: composite of QLQ-C30, questions 9 and 19; individual items from QLQ-LC13, questions 10, 11 and 12. Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.
time frame: Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: The randomised set.
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-iressa-7aece853
nct id: NCT01121393
trial label: BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)
applicability: unclear
applicability note: Attached because the study's own record names EGFR. 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-iressa-7aece853
nct id
NCT01121393
outcome key
om-0000
source section id
NCT01121393-om-0000
source outcome index
0
endpoint
Progression-free Survival
endpoint definition
The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS. Only data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates.
time origin
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The randomised set (RS) included all patients randomised to receive treatment, whether treated or not.
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-iressa-7aece853
nct id
NCT01121393
outcome key
om-0001
source section id
NCT01121393-om-0001
source outcome index
1
endpoint
Objective Response (OR)
endpoint definition
OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR. CR is defined as the disappearance of all target lesions and non-target lesions and no new lesions. PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions. (Exact 95% Confidence interval by Clopper and Pearson.)
time origin
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The randomised set.
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-iressa-7aece853
nct id
NCT01121393
outcome key
om-0002
source section id
NCT01121393-om-0002
source outcome index
2
endpoint
Disease Control (DC)
endpoint definition
DC is defined as a patient with objective response (OR) or stable disease (SD) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with DC.
time origin
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The randomised set.
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-iressa-7aece853
nct id
NCT01121393
outcome key
om-0003
source section id
NCT01121393-om-0003
source outcome index
3
endpoint
Overall Survival (OS)
endpoint definition
OS is defined as the time from randomisation to death. For patients who had not died until 7 December 2017, the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date. Median time results from unstratified Kaplan-Meier estimates.
time origin
From randomisation up to 374 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The randomised set.
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-iressa-7aece853
nct id
NCT01121393
outcome key
om-0004
source section id
NCT01121393-om-0004
source outcome index
4
endpoint
Time to Objective Response (OR)
endpoint definition
OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1. For patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response. Outcome data are the percentage of patients with OR by each scheduled tumour assessment.
time origin
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The RS included all patients randomised to receive treatment, whether treated or not.
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-iressa-7aece853
nct id
NCT01121393
outcome key
om-0005
source section id
NCT01121393-om-0005
source outcome index
5
endpoint
Duration of Objective Response
endpoint definition
OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1. For patients with an objective response, duration of objective response was defined as the time from the first objective response to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates.
time origin
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The Randomised set with an objective response.
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-iressa-7aece853
nct id
NCT01121393
outcome key
om-0000
arm key
OG000
arm label
Afatinib 40 Milligram (mg)
regimen
Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
analyzed count
242
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
outcome key
om-0000
arm key
OG001
arm label
Gemcitabine / Cisplatin Chemotherapy
regimen
Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
analyzed count
122
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
outcome key
om-0001
arm key
OG000
arm label
Afatinib 40 Milligram (mg)
regimen
Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
analyzed count
242
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
outcome key
om-0001
arm key
OG001
arm label
Gemcitabine / Cisplatin Chemotherapy
regimen
Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
analyzed count
122
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
outcome key
om-0002
arm key
OG000
arm label
Afatinib 40 Milligram (mg)
regimen
Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
analyzed count
242
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
outcome key
om-0002
arm key
OG001
arm label
Gemcitabine / Cisplatin Chemotherapy
regimen
Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
analyzed count
122
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
outcome key
om-0003
arm key
OG000
arm label
Afatinib 40 Milligram (mg)
regimen
Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
analyzed count
242
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
outcome key
om-0003
arm key
OG001
arm label
Gemcitabine / Cisplatin Chemotherapy
regimen
Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
analyzed count
122
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
outcome key
om-0004
arm key
OG000
arm label
Afatinib 40 Milligram (mg)
regimen
Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
analyzed count
242
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
outcome key
om-0004
arm key
OG001
arm label
Gemcitabine / Cisplatin Chemotherapy
regimen
Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
analyzed count
122
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
outcome key
om-0005
arm key
OG000
arm label
Afatinib 40 Milligram (mg)
regimen
Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
analyzed count
164
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
outcome key
om-0005
arm key
OG001
arm label
Gemcitabine / Cisplatin Chemotherapy
regimen
Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01121393-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT01121393
harm key
EG000
source section id
NCT01121393-ae
event group key
EG000
event group label
Afatinib 40 Milligram (mg)
serious affected
40
serious at risk
239
other affected
236
other at risk
239
frequency threshold
5
collection period
From first administration of study medication until 28 days after the last administration of study medication up to 374 weeks
event definition
The treated set (TS) included all randomised patients documented to have taken at least 1 dose of study medication. Analysis of Adverse Events (AEs) was based on the concept of treatment-emergent AEs. AEs with onset after the first administration of study drug and within 28 days after the last administration were considered to be on-treatment.
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-iressa-7aece853
nct id
NCT01121393
harm key
EG001
source section id
NCT01121393-ae
event group key
EG001
event group label
Gemcitabine / Cisplatin Chemotherapy
serious affected
12
serious at risk
113
other affected
112
other at risk
113
frequency threshold
5
collection period
From first administration of study medication until 28 days after the last administration of study medication up to 374 weeks
event definition
The treated set (TS) included all randomised patients documented to have taken at least 1 dose of study medication. Analysis of Adverse Events (AEs) was based on the concept of treatment-emergent AEs. AEs with onset after the first administration of study drug and within 28 days after the last administration were considered to be on-treatment.
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-iressa-7aece853
nct id
NCT01121393
qol key
qol-0010
source section id
NCT01121393-om-0010
source outcome index
10
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing
measure definition
HRQOL as measured by standardised questionnaires (EuropeanOrganisation for Research and Treatment of Cancer (EORTC)) quality of life questionaires (OLQ-C30) and its lung cancer module (QLQ-LC13). Analysis for cough: QLQ-LC13, question 1. Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.
time frame
Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The randomised set.
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-iressa-7aece853
nct id
NCT01121393
qol key
qol-0011
source section id
NCT01121393-om-0011
source outcome index
11
instrument
EORTC QLQ
instrument basis
matched 'qlq' in the study's own wording
scale title
Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea
measure definition
HRQOL as measured by OLQ-C30 and its lung cancer module (QLQ-LC13). Analysis for dyspnoea: composite of QLQ-LC13, questions 3 to 5; individual item from QLQ-C30, question 8. Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.
time frame
Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The randomised set.
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-iressa-7aece853
nct id
NCT01121393
qol key
qol-0012
source section id
NCT01121393-om-0012
source outcome index
12
instrument
EORTC QLQ
instrument basis
matched 'qlq' in the study's own wording
scale title
Health Related Quality of Life (HRQOL): Time of Deterioration in Pain
measure definition
HRQOL as measured by OLQ-C30 and its lung cancer module QLQ-LC13. Analysis for pain: composite of QLQ-C30, questions 9 and 19; individual items from QLQ-LC13, questions 10, 11 and 12. Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.
time frame
Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The randomised set.
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