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← OPDIVO: resectable Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (neoadjuvant) after prior therapy

NCT00949650 · STUDY IN CONTEXT

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

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

PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.

Randomised set (RS)

→

secondary · POSTED

OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.

RS.

→

secondary · POSTED

DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.

RS.

→

secondary · POSTED

OS was defined as time from randomisation to death.

RS.

→

secondary · POSTED

Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.

RS. There were only 203 patients in the Afatinib 40 mg arm and 101 patients in the Pemetrexed/Cisplatin Chemotherapy with tumour measurements.

→

secondary · POSTED

Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.

RS. Only patients with baseline and at least one post-baseline assessment were included.

→

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 to Deterioration in Coughing

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-opdivo-9408611e
nct id
NCT00949650
qol key
qol-0007
source section id
NCT00949650-om-0007
source outcome index
7
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing
measure definition
HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
time frame
Throughout the trial until progression (every 3 weeks).
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
increased (worse
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 · HRQOL: Time to Deterioration in Dyspnoea

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-opdivo-9408611e
nct id
NCT00949650
qol key
qol-0008
source section id
NCT00949650-om-0008
source outcome index
8
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
HRQOL: Time to Deterioration in Dyspnoea
measure definition
HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
time frame
Throughout the trial until progression (every 3 weeks).
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
increased (worse
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 · HRQOL: Time to Deterioration in Pain

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-opdivo-9408611e
nct id
NCT00949650
qol key
qol-0009
source section id
NCT00949650-om-0009
source outcome index
9
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
HRQOL: Time to Deterioration in Pain
measure definition
HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
time frame
Throughout the trial until progression (every 3 weeks).
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
increased (worse
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-opdivo-9408611e
nct id
NCT00949650
trial label
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0000
    source section id
    NCT00949650-om-0000
    source outcome index
    0
    endpoint
    Progression-Free Survival (PFS) Time
    endpoint definition
    PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.
    time origin
    Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomised set (RS)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0001
    source section id
    NCT00949650-om-0001
    source outcome index
    1
    endpoint
    Percentage of Patients With Objective Response (OR)
    endpoint definition
    OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.
    time origin
    Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0002
    source section id
    NCT00949650-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants With Disease Control (DC)
    endpoint definition
    DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.
    time origin
    Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0003
    source section id
    NCT00949650-om-0003
    source outcome index
    3
    endpoint
    Overall Survival (OS) Time
    endpoint definition
    OS was defined as time from randomisation to death.
    time origin
    From randomisation to cut-off date (17MAR2017).
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0004
    source section id
    NCT00949650-om-0004
    source outcome index
    4
    endpoint
    Tumour Shrinkage
    endpoint definition
    Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.
    time origin
    Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    RS. There were only 203 patients in the Afatinib 40 mg arm and 101 patients in the Pemetrexed/Cisplatin Chemotherapy with tumour measurements.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0005
    source section id
    NCT00949650-om-0005
    source outcome index
    5
    endpoint
    Change From Baseline in Body Weight
    endpoint definition
    Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.
    time origin
    Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    RS. Only patients with baseline and at least one post-baseline assessment were included.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Afatinib 40 mg
    regimen
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    analyzed count
    230
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Pemetrexed/Cisplatin Chemotherapy
    regimen
    Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
    analyzed count
    115
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Afatinib 40 mg
    regimen
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    analyzed count
    230
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Pemetrexed/Cisplatin Chemotherapy
    regimen
    Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
    analyzed count
    115
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Afatinib 40 mg
    regimen
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    analyzed count
    230
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Pemetrexed/Cisplatin Chemotherapy
    regimen
    Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
    analyzed count
    115
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Afatinib 40 mg
    regimen
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    analyzed count
    230
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Pemetrexed/Cisplatin Chemotherapy
    regimen
    Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
    analyzed count
    115
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Afatinib 40 mg
    regimen
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    analyzed count
    203
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Pemetrexed/Cisplatin Chemotherapy
    regimen
    Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
    analyzed count
    101
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Afatinib 40 mg
    regimen
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    analyzed count
    224
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Pemetrexed/Cisplatin Chemotherapy
    regimen
    Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
    analyzed count
    109
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00949650-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    harm key
    EG000
    source section id
    NCT00949650-ae
    event group key
    EG000
    event group label
    Afatinib 40 mg
    serious affected
    72
    serious at risk
    229
    other affected
    229
    other at risk
    229
    frequency threshold
    5
    collection period
    First administration of trial medication until 28 days after last administration of trial medication.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    harm key
    EG001
    source section id
    NCT00949650-ae
    event group key
    EG001
    event group label
    Pemetrexed/Cisplatin Chemotherapy
    serious affected
    25
    serious at risk
    111
    other affected
    108
    other at risk
    111
    frequency threshold
    5
    collection period
    First administration of trial medication until 28 days after last administration of trial medication.
    event definition
    Source null
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    qol key
    qol-0007
    source section id
    NCT00949650-om-0007
    source outcome index
    7
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing
    measure definition
    HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
    time frame
    Throughout the trial until progression (every 3 weeks).
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    increased (worse
    population note
    RS.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    qol key
    qol-0008
    source section id
    NCT00949650-om-0008
    source outcome index
    8
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    HRQOL: Time to Deterioration in Dyspnoea
    measure definition
    HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
    time frame
    Throughout the trial until progression (every 3 weeks).
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    increased (worse
    population note
    RS.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT00949650
    qol key
    qol-0009
    source section id
    NCT00949650-om-0009
    source outcome index
    9
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    HRQOL: Time to Deterioration in Pain
    measure definition
    HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
    time frame
    Throughout the trial until progression (every 3 weeks).
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    increased (worse
    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