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NCT00789373 · STUDY IN CONTEXT

A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer

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

Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

All randomized participants

→

secondary · POSTED

To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

Randomized participants with reviewable scan--(316/359 \[88%\] Maintenance arm and 156/180 \[87%\] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010).

→

secondary · POSTED

OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.

All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored.

→

secondary · POSTED

The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).

Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.

→

secondary · POSTED

Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).

Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.

→

secondary · POSTED

Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)

All randomized participants

→

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 · Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score

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-locally-advanced-c478f41c
nct id
NCT00789373
qol key
qol-0003
source section id
NCT00789373-om-0003
source outcome index
3
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score
measure definition
The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
time frame
Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (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-locally-advanced-c478f41c
nct id
NCT00789373
qol key
qol-0004
source section id
NCT00789373-om-0004
source outcome index
4
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)
measure definition
Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).
time frame
Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.
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-locally-advanced-c478f41c
nct id
NCT00789373
trial label
A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer
applicability
unclear
applicability note
Attached because the study's own record describes locally advanced 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
3
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0000
    source section id
    NCT00789373-om-0000
    source outcome index
    0
    endpoint
    Investigator-assessed Objective Progression-free Survival (PFS)
    endpoint definition
    Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.
    time origin
    Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)
    analysis role
    primary
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0001
    source section id
    NCT00789373-om-0001
    source outcome index
    1
    endpoint
    Independently-assessed Objective Progression-free Survival (PFS)
    endpoint definition
    To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.
    time origin
    Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized participants with reviewable scan--(316/359 \[88%\] Maintenance arm and 156/180 \[87%\] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010).
    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-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0002
    source section id
    NCT00789373-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.
    time origin
    Date of randomization to the date of death from any cause up to 39.5 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored.
    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-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0003
    source section id
    NCT00789373-om-0003
    source outcome index
    3
    endpoint
    Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score
    endpoint definition
    The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
    time origin
    Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.
    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-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0004
    source section id
    NCT00789373-om-0004
    source outcome index
    4
    endpoint
    Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)
    endpoint definition
    Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).
    time origin
    Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.
    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-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0005
    source section id
    NCT00789373-om-0005
    source outcome index
    5
    endpoint
    Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)
    endpoint definition
    Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)
    time origin
    Baseline randomization through 30-day post-discontinuation visit (up to 19.3 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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
    regimen
    pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
    analyzed count
    359
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Pemetrexed + Cisplatin Followed by Placebo
    regimen
    pemetrexed + cisplatin followed by placebo plus best supportive care
    analyzed count
    180
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
    regimen
    pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
    analyzed count
    316
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Pemetrexed + Cisplatin Followed by Placebo
    regimen
    pemetrexed + cisplatin followed by placebo plus best supportive care
    analyzed count
    156
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
    regimen
    pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
    analyzed count
    359
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Pemetrexed + Cisplatin Followed by Placebo
    regimen
    pemetrexed and cisplatin followed by placebo plus best supportive care
    analyzed count
    180
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
    regimen
    pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
    analyzed count
    303
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Pemetrexed + Cisplatin Followed by Placebo
    regimen
    pemetrexed + cisplatin followed by placebo plus best supportive care
    analyzed count
    153
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
    regimen
    pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
    analyzed count
    300
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Pemetrexed + Cisplatin Followed by Placebo
    regimen
    pemetrexed + cisplatin followed by placebo plus best supportive care
    analyzed count
    148
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
    regimen
    pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
    analyzed count
    359
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Pemetrexed + Cisplatin Followed by Placebo
    regimen
    pemetrexed + cisplatin followed by placebo plus best supportive care
    analyzed count
    180
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789373-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    harm key
    EG000
    source section id
    NCT00789373-ae
    event group key
    EG000
    event group label
    Induction Pemetrexed + Cisplatin
    serious affected
    257
    serious at risk
    939
    other affected
    759
    other at risk
    939
    frequency threshold
    5
    collection period
    From start of study up to approximately 108 months
    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-locally-advanced-c478f41c
    nct id
    NCT00789373
    harm key
    EG001
    source section id
    NCT00789373-ae
    event group key
    EG001
    event group label
    Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
    serious affected
    94
    serious at risk
    359
    other affected
    287
    other at risk
    359
    frequency threshold
    5
    collection period
    From start of study up to approximately 108 months
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    nct id
    NCT00789373
    harm key
    EG002
    source section id
    NCT00789373-ae
    event group key
    EG002
    event group label
    Pemetrexed + Cisplatin Followed by Placebo
    serious affected
    36
    serious at risk
    180
    other affected
    117
    other at risk
    180
    frequency threshold
    5
    collection period
    From start of study up to approximately 108 months
    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-locally-advanced-c478f41c
    nct id
    NCT00789373
    qol key
    qol-0003
    source section id
    NCT00789373-om-0003
    source outcome index
    3
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score
    measure definition
    The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
    time frame
    Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.
    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-locally-advanced-c478f41c
    nct id
    NCT00789373
    qol key
    qol-0004
    source section id
    NCT00789373-om-0004
    source outcome index
    4
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)
    measure definition
    Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).
    time frame
    Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.
    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