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← Zirabev: unresectable metastatic Non-small cell lung cancer (first-line)

NCT00982111 · STUDY IN CONTEXT

First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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

OS is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.

All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin =79, Pemetrexed + Cisplatin=72

→

secondary · POSTED

PFS is defined as the time from randomization until the first radiographic documentation of measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participant was censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.

All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin=84, Pemetrexed + Cisplatin=79

→

secondary · POSTED

ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.

All randomized participants.

→

secondary · POSTED

TTF was defined as the time from study enrollment/randomization to the first observation of measured progressive disease, death from any cause, or early discontinuation of treatment or initiation of new anti-cancer therapies. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of longest diameter of target lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.

All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin = 10, Pemetrexed + Cisplatin = 13

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secondary · POSTED

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab

Participants who were randomized to necitumumab and had evaluable PK data.

→

secondary · POSTED

A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-Necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.

All randomized participants who received at least one dose of necitumumab and had evaluable antibody data.

→

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

EQ-5D · Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (EQ-5D)

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-zirabev-6034532a
nct id
NCT00982111
qol key
qol-0006
source section id
NCT00982111-om-0006
source outcome index
6
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (EQ-5D)
measure definition
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
time frame
Baseline, Cycle 6 (Cycle = 3 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All randomized participants who had evaluable baseline and postbaseline EQ-5D data.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)

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-zirabev-6034532a
nct id
NCT00982111
qol key
qol-0007
source section id
NCT00982111-om-0007
source outcome index
7
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
measure definition
The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.
time frame
Baseline, Cycle 6 (Cycle =3 Weeks)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All randomized participants who had evaluable baseline and postbaseline LCSS data.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)

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-zirabev-6034532a
nct id
NCT00982111
qol key
qol-0008
source section id
NCT00982111-om-0008
source outcome index
8
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
measure definition
EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of \< 200 and participants with a high EGFR expression defined by a H-score of cutoff value of \>=200.
time frame
Baseline
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment.
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-zirabev-6034532a
nct id
NCT00982111
trial label
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
applicability
unclear
applicability note
Attached because the study's own record describes metastatic 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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0000
    source section id
    NCT00982111-om-0000
    source outcome index
    0
    endpoint
    Overall Survival Time (OS)
    endpoint definition
    OS is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.
    time origin
    Randomization to Death from Any Cause (Up to 31.6 Months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin =79, Pemetrexed + Cisplatin=72
    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-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0001
    source section id
    NCT00982111-om-0001
    source outcome index
    1
    endpoint
    Progression-Free Survival (PFS)
    endpoint definition
    PFS is defined as the time from randomization until the first radiographic documentation of measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participant was censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.
    time origin
    Randomization to Measured Progressive Disease or Death from Any Cause (Up to 30.4 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin=84, Pemetrexed + Cisplatin=79
    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-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0002
    source section id
    NCT00982111-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate [ORR])
    endpoint definition
    ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.
    time origin
    Baseline to Measured Progressive Disease (Up to 30.4 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants.
    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-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0003
    source section id
    NCT00982111-om-0003
    source outcome index
    3
    endpoint
    Time to Treatment Failure (TTF)
    endpoint definition
    TTF was defined as the time from study enrollment/randomization to the first observation of measured progressive disease, death from any cause, or early discontinuation of treatment or initiation of new anti-cancer therapies. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of longest diameter of target lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.
    time origin
    Randomization to Measured Progressive Disease, Death from Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 30.4 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin = 10, Pemetrexed + Cisplatin = 13
    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-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0004
    source section id
    NCT00982111-om-0004
    source outcome index
    4
    endpoint
    Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
    endpoint definition
    Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
    time origin
    Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who were randomized to necitumumab and had evaluable PK data.
    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-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0005
    source section id
    NCT00982111-om-0005
    source outcome index
    5
    endpoint
    Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)
    endpoint definition
    A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-Necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.
    time origin
    Baseline to Study Completion (Up to 31.6 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants who received at least one dose of necitumumab and had evaluable antibody data.
    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-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Necitumumab + Pemetrexed + Cisplatin
    regimen
    Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    analyzed count
    315
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00982111-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Pemetrexed + Cisplatin
    regimen
    Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    analyzed count
    318
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00982111-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Necitumumab + Pemetrexed + Cisplatin
    regimen
    Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    analyzed count
    315
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00982111-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Pemetrexed + Cisplatin
    regimen
    Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    analyzed count
    318
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00982111-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Necitumumab + Pemetrexed + Cisplatin
    regimen
    Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    analyzed count
    315
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00982111-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Pemetrexed + Cisplatin
    regimen
    Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    analyzed count
    318
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00982111-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Necitumumab + Pemetrexed + Cisplatin
    regimen
    Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    analyzed count
    315
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00982111-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Pemetrexed + Cisplatin
    regimen
    Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    analyzed count
    318
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00982111-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Necitumumab + Pemetrexed + Cisplatin
    regimen
    Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    analyzed count
    315
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00982111-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-zirabev-6034532a
    nct id
    NCT00982111
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Necitumumab + Pemextrexed + Cisplatin
    regimen
    Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    analyzed count
    301
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00982111-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-zirabev-6034532a
    nct id
    NCT00982111
    harm key
    EG000
    source section id
    NCT00982111-ae
    event group key
    EG000
    event group label
    Necitumumab+Pemetrexed+Cisplatin
    serious affected
    158
    serious at risk
    304
    other affected
    296
    other at risk
    304
    frequency threshold
    5
    collection period
    Source null
    event definition
    All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
    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-zirabev-6034532a
    nct id
    NCT00982111
    harm key
    EG001
    source section id
    NCT00982111-ae
    event group key
    EG001
    event group label
    Pemetrexed+Cisplatin
    serious affected
    130
    serious at risk
    312
    other affected
    303
    other at risk
    312
    frequency threshold
    5
    collection period
    Source null
    event definition
    All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
    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-zirabev-6034532a
    nct id
    NCT00982111
    qol key
    qol-0006
    source section id
    NCT00982111-om-0006
    source outcome index
    6
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (EQ-5D)
    measure definition
    The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
    time frame
    Baseline, Cycle 6 (Cycle = 3 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All randomized participants who had evaluable baseline and postbaseline EQ-5D data.
    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-zirabev-6034532a
    nct id
    NCT00982111
    qol key
    qol-0007
    source section id
    NCT00982111-om-0007
    source outcome index
    7
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
    measure definition
    The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.
    time frame
    Baseline, Cycle 6 (Cycle =3 Weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All randomized participants who had evaluable baseline and postbaseline LCSS data.
    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-zirabev-6034532a
    nct id
    NCT00982111
    qol key
    qol-0008
    source section id
    NCT00982111-om-0008
    source outcome index
    8
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
    measure definition
    EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of \< 200 and participants with a high EGFR expression defined by a H-score of cutoff value of \>=200.
    time frame
    Baseline
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment.
    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