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← Stage IV recurrent Non-Small Cell Lung Cancer

NCT00101413 · STUDY IN CONTEXT

BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)

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

CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- \>=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- \>=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- \>clinically meaningful cancer-related deterioration as judged by the investigator.

The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.

→

secondary · POSTED

Duration of stable disease was calculated as date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Kaplan-Meier methodology, descriptive analysis.

The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 1 of the 52 subjects had lung metastases from pancreatic cancer and was excluded from analysis. 48 subjects had tumor evaluations post-baseline and were evaluable.

→

secondary · POSTED

Overall survival was calculated from the date of the first treatment until death of the subject. Evaluation by Kaplan-Meier methodology, descriptive analysis.

The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.

→

secondary · POSTED

Percentage of subjects with stable disease was calculated from date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Descriptive summary of subjects with SD.

The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.

→

secondary · POSTED

HRQoL was assessed with the FACT-L questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores (negative change from baseline) demonstrate impaired HRQoL.

The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. Of the 52 treated subjects, 50 subjects completed the FACT-L at baseline (screening) and post-treatment.

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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

FACT · Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)

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-stage-iv-recurrent-6637f002
nct id
NCT00101413
qol key
qol-0004
source section id
NCT00101413-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'fact-l' in the study's own wording
scale title
Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)
measure definition
HRQoL was assessed with the FACT-L questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores (negative change from baseline) demonstrate impaired HRQoL.
time frame
From first patient first treatment until date of last efficacy data collection (study period up to 62 weeks). HRQoL assessed at baseline (BL), end of treatment Cycles 2 and 4, and at end of treatment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. Of the 52 treated subjects, 50 subjects completed the FACT-L at baseline (screening) and post-treatment.
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-stage-iv-recurrent-6637f002
nct id
NCT00101413
trial label
BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)
applicability
unclear
applicability note
Attached because the study's own record describes recurrent 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
5
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    outcome key
    om-0000
    source section id
    NCT00101413-om-0000
    source outcome index
    0
    endpoint
    Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)
    endpoint definition
    CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- \>=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- \>=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- \>clinically meaningful cancer-related deterioration as judged by the investigator.
    time origin
    First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.
    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-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    outcome key
    om-0001
    source section id
    NCT00101413-om-0001
    source outcome index
    1
    endpoint
    Duration of Stable Disease
    endpoint definition
    Duration of stable disease was calculated as date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Kaplan-Meier methodology, descriptive analysis.
    time origin
    First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 1 of the 52 subjects had lung metastases from pancreatic cancer and was excluded from analysis. 48 subjects had tumor evaluations post-baseline and were evaluable.
    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-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    outcome key
    om-0002
    source section id
    NCT00101413-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Overall survival was calculated from the date of the first treatment until death of the subject. Evaluation by Kaplan-Meier methodology, descriptive analysis.
    time origin
    First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.
    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-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    outcome key
    om-0003
    source section id
    NCT00101413-om-0003
    source outcome index
    3
    endpoint
    Percentage of Subjects With Stable Disease (SD)
    endpoint definition
    Percentage of subjects with stable disease was calculated from date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Descriptive summary of subjects with SD.
    time origin
    First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.
    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-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    outcome key
    om-0004
    source section id
    NCT00101413-om-0004
    source outcome index
    4
    endpoint
    Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)
    endpoint definition
    HRQoL was assessed with the FACT-L questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores (negative change from baseline) demonstrate impaired HRQoL.
    time origin
    From first patient first treatment until date of last efficacy data collection (study period up to 62 weeks). HRQoL assessed at baseline (BL), end of treatment Cycles 2 and 4, and at end of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. Of the 52 treated subjects, 50 subjects completed the FACT-L at baseline (screening) and post-treatment.
    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-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Sorafenib
    regimen
    Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
    analyzed count
    51
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00101413-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Sorafenib
    regimen
    Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
    analyzed count
    48
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00101413-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Sorafenib
    regimen
    Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
    analyzed count
    51
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00101413-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Sorafenib
    regimen
    Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
    analyzed count
    51
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00101413-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Sorafenib
    regimen
    Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00101413-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    harm key
    EG000
    source section id
    NCT00101413-ae
    event group key
    EG000
    event group label
    Sorafenib
    serious affected
    28
    serious at risk
    52
    other affected
    51
    other at risk
    52
    frequency threshold
    5
    collection period
    AE data were collected from Apr 2004 to Apr 2008
    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-stage-iv-recurrent-6637f002
    nct id
    NCT00101413
    qol key
    qol-0004
    source section id
    NCT00101413-om-0004
    source outcome index
    4
    instrument
    FACT
    instrument basis
    matched 'fact-l' in the study's own wording
    scale title
    Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)
    measure definition
    HRQoL was assessed with the FACT-L questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores (negative change from baseline) demonstrate impaired HRQoL.
    time frame
    From first patient first treatment until date of last efficacy data collection (study period up to 62 weeks). HRQoL assessed at baseline (BL), end of treatment Cycles 2 and 4, and at end of treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. Of the 52 treated subjects, 50 subjects completed the FACT-L at baseline (screening) and post-treatment.
    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