← PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND: metastatic Non-small cell lung cancer (first-line)

NCT00556322 · STUDY IN CONTEXT

A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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

Overall survival (OS) was determined from the date of randomization to the date of death irrespective of the cause of death.

FAS population

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primary · POSTED

OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.

FAS population

→

primary · POSTED

OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.

FAS population

→

secondary · POSTED

EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by immunohistochemistry (IHC). OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.

FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. number (n) equals (=) number of participants who were EGFR positive or negative

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secondary · POSTED

EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.

FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative

→

secondary · POSTED

EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.

FAS population; n=number of EGFR positive or negative participants remaining at risk

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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.

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Quality of life and patient-reported measures

FACT · Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population

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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id: NCT00556322
qol key: qol-0003
source section id: NCT00556322-om-0003
source outcome index: 3
instrument: FACT
instrument basis: matched 'factor' in the study's own wording
scale title: Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population
measure definition: EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by immunohistochemistry (IHC). OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.
time frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. number (n) equals (=) number of participants who were EGFR positive or negative
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

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FACT · Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)

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

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id: NCT00556322
qol key: qol-0013
source section id: NCT00556322-om-0013
source outcome index: 13
instrument: FACT
instrument basis: matched 'fact-l' in the study's own wording
scale title: Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)
measure definition: The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.
time frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher scores represent better
population note: FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Time to Deterioration in Quality of Life Using FACT-L

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

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id: NCT00556322
qol key: qol-0014
source section id: NCT00556322-om-0014
source outcome index: 14
instrument: FACT
instrument basis: matched 'fact-l' in the study's own wording
scale title: Time to Deterioration in Quality of Life Using FACT-L
measure definition: The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Time to deterioration of QoL or symptom progression is defined as time from randomization until either a clinically meaningful decline from baseline in Total FACT-L or, death on study, whichever occurs first. The clinically meaningful decline that was used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Kaplan-Meier estimate was used to determine time to event.
time frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher scores represent better
population note: FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

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FACT · Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L

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

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id: NCT00556322
qol key: qol-0015
source section id: NCT00556322-om-0015
source outcome index: 15
instrument: FACT
instrument basis: matched 'fact-l' in the study's own wording
scale title: Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L
measure definition: The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Kaplan Meier estimates were used for analysis.
time frame: 6 Months
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher scores represent better
population note: FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Percentage of Participants With Symptomatic Progression Using FACT-L

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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id: NCT00556322
qol key: qol-0016
source section id: NCT00556322-om-0016
source outcome index: 16
instrument: FACT
instrument basis: matched 'fact-l' in the study's own wording
scale title: Percentage of Participants With Symptomatic Progression Using FACT-L
measure definition: Participants' responses on the FACT-L were scored according to the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline.
time frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Time to Symptomatic Progression Using FACT-L

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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id: NCT00556322
qol key: qol-0017
source section id: NCT00556322-om-0017
source outcome index: 17
instrument: FACT
instrument basis: matched 'fact-l' in the study's own wording
scale title: Time to Symptomatic Progression Using FACT-L
measure definition: Participants' responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.
time frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L

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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id: NCT00556322
qol key: qol-0018
source section id: NCT00556322-om-0018
source outcome index: 18
instrument: FACT
instrument basis: matched 'fact-l' in the study's own wording
scale title: Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L
measure definition: Participants' responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.
time frame: 6 Months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)

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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id: NCT00556322
qol key: qol-0019
source section id: NCT00556322-om-0019
source outcome index: 19
instrument: FACT
instrument basis: matched 'fact-l' in the study's own wording
scale title: Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)
measure definition: TOI is defined as the sum of the scores of the Physical Well- Being (PWB), Functional Well-Being (FWB), and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline.
time frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Time to Deterioration in the TOI

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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id: NCT00556322
qol key: qol-0020
source section id: NCT00556322-om-0020
source outcome index: 20
instrument: FACT
instrument basis: matched 'fact-l' in the study's own wording
scale title: Time to Deterioration in the TOI
measure definition: TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6- point decline from baseline. Kaplan-Meier estimates were used for analysis.
time frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L

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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id: NCT00556322
qol key: qol-0021
source section id: NCT00556322-om-0021
source outcome index: 21
instrument: FACT
instrument basis: matched 'fact-l' in the study's own wording
scale title: Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L
measure definition: TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Kaplan-Meier estimates were used for analysis.
time frame: 6 Months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id: NCT00556322
trial label: A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
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: 10

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0000
source section id
NCT00556322-om-0000
source outcome index
0
endpoint
Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)
endpoint definition
Overall survival (OS) was determined from the date of randomization to the date of death irrespective of the cause of death.
time origin
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
FAS population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0001
source section id
NCT00556322-om-0001
source outcome index
1
endpoint
Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)
endpoint definition
OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.
time origin
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
FAS population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0002
source section id
NCT00556322-om-0002
source outcome index
2
endpoint
Probable Percentage of Participants Remaining Alive at 1 Year
endpoint definition
OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.
time origin
1 Year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
FAS population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0003
source section id
NCT00556322-om-0003
source outcome index
3
endpoint
Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population
endpoint definition
EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by immunohistochemistry (IHC). OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.
time origin
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. number (n) equals (=) number of participants who were EGFR positive or negative
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0004
source section id
NCT00556322-om-0004
source outcome index
4
endpoint
Duration of OS in EGFR Positive and Negative Population
endpoint definition
EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.
time origin
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0005
source section id
NCT00556322-om-0005
source outcome index
5
endpoint
Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population
endpoint definition
EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.
time origin
1 Year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
FAS population; n=number of EGFR positive or negative participants remaining at risk
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0000
arm key
OG000
arm label
Comparator
regimen
Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
analyzed count
221
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0000
arm key
OG001
arm label
Erlotinib
regimen
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
analyzed count
203
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0001
arm key
OG000
arm label
Comparator
regimen
Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
analyzed count
221
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0001
arm key
OG001
arm label
Erlotinib
regimen
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
analyzed count
203
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0002
arm key
OG000
arm label
Comparator
regimen
Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
analyzed count
221
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0002
arm key
OG001
arm label
Erlotinib
regimen
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
analyzed count
203
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0003
arm key
OG000
arm label
Comparator
regimen
Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
analyzed count
188
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0003
arm key
OG001
arm label
Erlotinib
regimen
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
analyzed count
175
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0004
arm key
OG000
arm label
Comparator
regimen
Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
analyzed count
188
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0004
arm key
OG001
arm label
Erlotinib
regimen
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
analyzed count
175
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0005
arm key
OG000
arm label
Comparator
regimen
Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel l75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
analyzed count
221
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
outcome key
om-0005
arm key
OG001
arm label
Erlotinib
regimen
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
analyzed count
203
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00556322-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
harm key
EG000
source section id
NCT00556322-ae
event group key
EG000
event group label
Comparator
serious affected
31
serious at risk
213
other affected
106
other at risk
213
frequency threshold
5
collection period
All adverse events (related and unrelated) occurring during the study and for up to 28 days after the last dose of study medication were reported.
event definition
All participants who received at least one dose of the trial medication and had at least one safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population (SAP).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
harm key
EG001
source section id
NCT00556322-ae
event group key
EG001
event group label
Erlotinib
serious affected
20
serious at risk
196
other affected
125
other at risk
196
frequency threshold
5
collection period
All adverse events (related and unrelated) occurring during the study and for up to 28 days after the last dose of study medication were reported.
event definition
All participants who received at least one dose of the trial medication and had at least one safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population (SAP).
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

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
qol key
qol-0003
source section id
NCT00556322-om-0003
source outcome index
3
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population
measure definition
EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by immunohistochemistry (IHC). OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.
time frame
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. number (n) equals (=) number of participants who were EGFR positive or negative
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
qol key
qol-0013
source section id
NCT00556322-om-0013
source outcome index
13
instrument
FACT
instrument basis
matched 'fact-l' in the study's own wording
scale title
Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)
measure definition
The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.
time frame
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores represent better
population note
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
qol key
qol-0014
source section id
NCT00556322-om-0014
source outcome index
14
instrument
FACT
instrument basis
matched 'fact-l' in the study's own wording
scale title
Time to Deterioration in Quality of Life Using FACT-L
measure definition
The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Time to deterioration of QoL or symptom progression is defined as time from randomization until either a clinically meaningful decline from baseline in Total FACT-L or, death on study, whichever occurs first. The clinically meaningful decline that was used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Kaplan-Meier estimate was used to determine time to event.
time frame
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores represent better
population note
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
qol key
qol-0015
source section id
NCT00556322-om-0015
source outcome index
15
instrument
FACT
instrument basis
matched 'fact-l' in the study's own wording
scale title
Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L
measure definition
The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Kaplan Meier estimates were used for analysis.
time frame
6 Months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores represent better
population note
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
qol key
qol-0016
source section id
NCT00556322-om-0016
source outcome index
16
instrument
FACT
instrument basis
matched 'fact-l' in the study's own wording
scale title
Percentage of Participants With Symptomatic Progression Using FACT-L
measure definition
Participants' responses on the FACT-L were scored according to the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline.
time frame
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
qol key
qol-0017
source section id
NCT00556322-om-0017
source outcome index
17
instrument
FACT
instrument basis
matched 'fact-l' in the study's own wording
scale title
Time to Symptomatic Progression Using FACT-L
measure definition
Participants' responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.
time frame
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
qol key
qol-0018
source section id
NCT00556322-om-0018
source outcome index
18
instrument
FACT
instrument basis
matched 'fact-l' in the study's own wording
scale title
Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L
measure definition
Participants' responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.
time frame
6 Months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
qol key
qol-0019
source section id
NCT00556322-om-0019
source outcome index
19
instrument
FACT
instrument basis
matched 'fact-l' in the study's own wording
scale title
Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)
measure definition
TOI is defined as the sum of the scores of the Physical Well- Being (PWB), Functional Well-Being (FWB), and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline.
time frame
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
qol key
qol-0020
source section id
NCT00556322-om-0020
source outcome index
20
instrument
FACT
instrument basis
matched 'fact-l' in the study's own wording
scale title
Time to Deterioration in the TOI
measure definition
TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6- point decline from baseline. Kaplan-Meier estimates were used for analysis.
time frame
Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT00556322
qol key
qol-0021
source section id
NCT00556322-om-0021
source outcome index
21
instrument
FACT
instrument basis
matched 'fact-l' in the study's own wording
scale title
Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L
measure definition
TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Kaplan-Meier estimates were used for analysis.
time frame
6 Months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
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