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NCT01774721 · STUDY IN CONTEXT

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced 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

PFS: time from randomization to date of progression of disease (PD) as determined by IRC review as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause, whichever occurred first. PD: \>=20% increase in sum of diameters of target lesions (TLs), referring smallest sum on study, sum must be an absolute increase of \>=5 mm, appearance of \>=1 new lesions; unequivocal progression of existing non TLs. Overall tumor burden increased sufficiently to merit discontinuation of therapy. In presence of stable disease (did not achieve partial response, complete response or PD) or partial response (\>=30% decrease under baseline of sum of diameters of all target measurable lesions, short diameter used in the sum for target nodes, longest diameter used in sum for all other target lesions) in target disease; for new lesions: appearance of any new unequivocal malignant lesion indicated PD.

Intent to treat (ITT) Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.

→

secondary · POSTED

OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. OS (month)=\[death date or last known alive date - randomization date + 1\]/30.4375.

ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.

→

secondary · POSTED

OS30m was defined as the probability of a participant being alive at 30 months from date of randomization.

ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.

→

secondary · POSTED

PFS: time from randomization to date of PD as determined by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause, whichever occurred first. PD for target lesions: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm; for non-target lesions: unequivocal progression of pre-existing lesions. Overall tumor burden increased sufficiently to merit discontinuation of therapy. In presence of stable disease (did not achieve partial response, complete response or PD) or partial response (\>=30% decrease under baseline of sum of diameters of all target measurable lesions, short diameter used in the sum for target nodes, longest diameter used in sum for all other target lesions) in target disease; for new lesions: appearance of any new unequivocal malignant lesion indicated PD.

ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.

→

secondary · POSTED

BOR for CR/PR:\>=1 objective status (OBS) of CR/PR documented before PD; SD:\>=1 OBS of stable documented \>=8 weeks (wks) post treatment \& before PD, not qualifying as CR/PR; PD:OBS of PD within 12 wks treatment, not qualifying as CR/PR/SD; indeterminate:PD not documented within 12 wks post treatment \& no other response category applies. RECIST v1.1, CR:disappearance of all target lesions (TLs), non TLs;any pathological lymph nodes (LN) must reduce in short axis to \<10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (\<10 mm short axis); PR:\>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referring smallest sum diameters on study. PD:\>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of \>=5 mm, appearance of \>=1 new lesions;unequivocal progression of existing non TLs.

ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.

→

secondary · POSTED

BOR for CR/PR:\>=1 objective status (OBS) of CR/PR documented before PD; SD:\>=1 OBS of stable documented \>=8 weeks (wks) post treatment \& before PD, not qualifying as CR/PR; PD:OBS of PD within 12 wks treatment, not qualifying as CR/PR/SD; indeterminate:PD not documented within 12 wks post treatment \& no other response category applies. RECIST v1.1, CR:disappearance of all target lesions (TLs), non TLs;any pathological lymph nodes (LN) must reduce in short axis to \<10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (\<10 mm short axis); PR:\>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referring smallest sum diameters on study. PD:\>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of \>=5 mm, appearance of \>=1 new lesions;unequivocal progression of existing non TLs.

ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.

→

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 (TTD) in Pain, Dyspnea, Fatigue or Cough

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-opdivo-9408611e
nct id
NCT01774721
qol key
qol-0015
source section id
NCT01774721-om-0015
source outcome index
15
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Health Related Quality of Life (HRQOL): Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough
measure definition
HRQOL was measured by standardized questionnaires (European Organization for Research and Treatment of Cancer (EORTC)) quality of life questionnaires (OLQ-C30) and its lung cancer module (QLQ-LC13). TTD in pain (chest, arm/shoulder), dyspnea, fatigue or cough was defined as time between baseline and first occurrence of increase in score of 10 points or greater from baseline in any of these 4 symptoms for at least two consecutive cycles. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment for pain, dyspnea, fatigue or cough.
time frame
Baseline until the end of treatment (up to 48 months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Patient reported outcomes (PRO) analysis set included all enrolled participants, who started treatment and completed a baseline PRO assessments and at least one post-baseline PRO assessment after the first dose.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Overall Mean Scores of Euro Quality of Life-5 Dimension Visual Analog Scale (EQ-5D VAS)

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-opdivo-9408611e
nct id
NCT01774721
qol key
qol-0016
source section id
NCT01774721-om-0016
source outcome index
16
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Overall Mean Scores of Euro Quality of Life-5 Dimension Visual Analog Scale (EQ-5D VAS)
measure definition
The Euro Quality of Life-5 dimension (EQ-5D) is a brief self-administered, validated reliable generic health status instrument. EQ-5D general health status can also be measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
time frame
From Cycle 1 Day 1 up to 48 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
PRO analysis set included all enrolled participants, who started treatment and completed a baseline PRO assessments and at least one post-baseline PRO assessment after the first dose. Here "N" signifies number of participants who were evaluable for this specified outcome measure.
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
NCT01774721
trial label
ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced 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
3
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0000
    source section id
    NCT01774721-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS) Based on Independent Radiologic Central (IRC) Review
    endpoint definition
    PFS: time from randomization to date of progression of disease (PD) as determined by IRC review as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause, whichever occurred first. PD: \>=20% increase in sum of diameters of target lesions (TLs), referring smallest sum on study, sum must be an absolute increase of \>=5 mm, appearance of \>=1 new lesions; unequivocal progression of existing non TLs. Overall tumor burden increased sufficiently to merit discontinuation of therapy. In presence of stable disease (did not achieve partial response, complete response or PD) or partial response (\>=30% decrease under baseline of sum of diameters of all target measurable lesions, short diameter used in the sum for target nodes, longest diameter used in sum for all other target lesions) in target disease; for new lesions: appearance of any new unequivocal malignant lesion indicated PD.
    time origin
    Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent to treat (ITT) Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
    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
    NCT01774721
    outcome key
    om-0001
    source section id
    NCT01774721-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. OS (month)=\[death date or last known alive date - randomization date + 1\]/30.4375.
    time origin
    From randomization until death or last date known as alive, up to 45 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
    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
    NCT01774721
    outcome key
    om-0002
    source section id
    NCT01774721-om-0002
    source outcome index
    2
    endpoint
    OS at 30 Months (OS30m)
    endpoint definition
    OS30m was defined as the probability of a participant being alive at 30 months from date of randomization.
    time origin
    Up to 30 months from date of randomization
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
    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
    NCT01774721
    outcome key
    om-0003
    source section id
    NCT01774721-om-0003
    source outcome index
    3
    endpoint
    Progression Free Survival (PFS) Based on Investigator Assessment
    endpoint definition
    PFS: time from randomization to date of PD as determined by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause, whichever occurred first. PD for target lesions: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm; for non-target lesions: unequivocal progression of pre-existing lesions. Overall tumor burden increased sufficiently to merit discontinuation of therapy. In presence of stable disease (did not achieve partial response, complete response or PD) or partial response (\>=30% decrease under baseline of sum of diameters of all target measurable lesions, short diameter used in the sum for target nodes, longest diameter used in sum for all other target lesions) in target disease; for new lesions: appearance of any new unequivocal malignant lesion indicated PD.
    time origin
    Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
    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
    NCT01774721
    outcome key
    om-0004
    source section id
    NCT01774721-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With Best Overall Response (BOR) Based on IRC Review
    endpoint definition
    BOR for CR/PR:\>=1 objective status (OBS) of CR/PR documented before PD; SD:\>=1 OBS of stable documented \>=8 weeks (wks) post treatment \& before PD, not qualifying as CR/PR; PD:OBS of PD within 12 wks treatment, not qualifying as CR/PR/SD; indeterminate:PD not documented within 12 wks post treatment \& no other response category applies. RECIST v1.1, CR:disappearance of all target lesions (TLs), non TLs;any pathological lymph nodes (LN) must reduce in short axis to \<10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (\<10 mm short axis); PR:\>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referring smallest sum diameters on study. PD:\>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of \>=5 mm, appearance of \>=1 new lesions;unequivocal progression of existing non TLs.
    time origin
    Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
    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
    NCT01774721
    outcome key
    om-0005
    source section id
    NCT01774721-om-0005
    source outcome index
    5
    endpoint
    Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment
    endpoint definition
    BOR for CR/PR:\>=1 objective status (OBS) of CR/PR documented before PD; SD:\>=1 OBS of stable documented \>=8 weeks (wks) post treatment \& before PD, not qualifying as CR/PR; PD:OBS of PD within 12 wks treatment, not qualifying as CR/PR/SD; indeterminate:PD not documented within 12 wks post treatment \& no other response category applies. RECIST v1.1, CR:disappearance of all target lesions (TLs), non TLs;any pathological lymph nodes (LN) must reduce in short axis to \<10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (\<10 mm short axis); PR:\>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referring smallest sum diameters on study. PD:\>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of \>=5 mm, appearance of \>=1 new lesions;unequivocal progression of existing non TLs.
    time origin
    Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
    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
    NCT01774721
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Dacomitinib
    regimen
    Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    227
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Gefitinib
    regimen
    Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Dacomitinib
    regimen
    Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    227
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Gefitinib
    regimen
    Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Dacomitinib
    regimen
    Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    227
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Gefitinib
    regimen
    Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Dacomitinib
    regimen
    Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    227
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Gefitinib
    regimen
    Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Dacomitinib
    regimen
    Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    227
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Gefitinib
    regimen
    Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Dacomitinib
    regimen
    Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    227
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-opdivo-9408611e
    nct id
    NCT01774721
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Gefitinib
    regimen
    Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01774721-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
    NCT01774721
    harm key
    EG000
    source section id
    NCT01774721-ae
    event group key
    EG000
    event group label
    Dacomitinib
    serious affected
    69
    serious at risk
    227
    other affected
    224
    other at risk
    227
    frequency threshold
    5
    collection period
    From randomization until death or last date known as alive, up to 91 months
    event definition
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
    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
    NCT01774721
    harm key
    EG001
    source section id
    NCT01774721-ae
    event group key
    EG001
    event group label
    Gefitinib
    serious affected
    53
    serious at risk
    224
    other affected
    217
    other at risk
    224
    frequency threshold
    5
    collection period
    From randomization until death or last date known as alive, up to 91 months
    event definition
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
    undenominated note
    Source null
    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
    NCT01774721
    harm key
    EG002
    source section id
    NCT01774721-ae
    event group key
    EG002
    event group label
    Dacomitinib (Ongoing at DCO)
    serious affected
    4
    serious at risk
    11
    other affected
    11
    other at risk
    11
    frequency threshold
    5
    collection period
    From randomization until death or last date known as alive, up to 91 months
    event definition
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
    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
    NCT01774721
    qol key
    qol-0015
    source section id
    NCT01774721-om-0015
    source outcome index
    15
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Health Related Quality of Life (HRQOL): Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough
    measure definition
    HRQOL was measured by standardized questionnaires (European Organization for Research and Treatment of Cancer (EORTC)) quality of life questionnaires (OLQ-C30) and its lung cancer module (QLQ-LC13). TTD in pain (chest, arm/shoulder), dyspnea, fatigue or cough was defined as time between baseline and first occurrence of increase in score of 10 points or greater from baseline in any of these 4 symptoms for at least two consecutive cycles. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment for pain, dyspnea, fatigue or cough.
    time frame
    Baseline until the end of treatment (up to 48 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Patient reported outcomes (PRO) analysis set included all enrolled participants, who started treatment and completed a baseline PRO assessments and at least one post-baseline PRO assessment after the first dose.
    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
    NCT01774721
    qol key
    qol-0016
    source section id
    NCT01774721-om-0016
    source outcome index
    16
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Overall Mean Scores of Euro Quality of Life-5 Dimension Visual Analog Scale (EQ-5D VAS)
    measure definition
    The Euro Quality of Life-5 dimension (EQ-5D) is a brief self-administered, validated reliable generic health status instrument. EQ-5D general health status can also be measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
    time frame
    From Cycle 1 Day 1 up to 48 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    PRO analysis set included all enrolled participants, who started treatment and completed a baseline PRO assessments and at least one post-baseline PRO assessment after the first dose. Here "N" signifies number of participants who were evaluable for this specified outcome measure.
    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