A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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 defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.

ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.

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secondary · POSTED

ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

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secondary · POSTED

PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

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secondary · POSTED

DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.

ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

→

secondary · POSTED

ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l\< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

→

secondary · POSTED

PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

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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

No linked quality-of-life measure is recorded for this setting and study.

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: NCT01903993
trial label: A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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: 0

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
NCT01903993
outcome key
om-0000
source section id
NCT01903993-om-0000
source outcome index
0
endpoint
Overall Survival (OS)
endpoint definition
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
time origin
From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
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
NCT01903993
outcome key
om-0001
source section id
NCT01903993-om-0001
source outcome index
1
endpoint
Objective Response Rate (ORR)
endpoint definition
ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
time origin
Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
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
NCT01903993
outcome key
om-0002
source section id
NCT01903993-om-0002
source outcome index
2
endpoint
Progression-Free Survival (PFS)
endpoint definition
PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
time origin
From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
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
NCT01903993
outcome key
om-0003
source section id
NCT01903993-om-0003
source outcome index
3
endpoint
Duration of Response (DOR)
endpoint definition
DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
time origin
From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
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
NCT01903993
outcome key
om-0004
source section id
NCT01903993-om-0004
source outcome index
4
endpoint
ORR (Modified RECIST)
endpoint definition
ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l\< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
time origin
From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only
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
NCT01903993
outcome key
om-0005
source section id
NCT01903993-om-0005
source outcome index
5
endpoint
PFS (Modified RECIST)
endpoint definition
PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
time origin
From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only
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
NCT01903993
outcome key
om-0000
arm key
OG000
arm label
Docetaxel
regimen
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
analyzed count
143
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01903993-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
NCT01903993
outcome key
om-0000
arm key
OG001
arm label
Atezolizumab
regimen
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
analyzed count
144
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01903993-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
NCT01903993
outcome key
om-0001
arm key
OG000
arm label
Docetaxel
regimen
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
analyzed count
143
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01903993-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
NCT01903993
outcome key
om-0001
arm key
OG001
arm label
Atezolizumab
regimen
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
analyzed count
144
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01903993-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
NCT01903993
outcome key
om-0002
arm key
OG000
arm label
Docetaxel
regimen
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
analyzed count
143
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01903993-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
NCT01903993
outcome key
om-0002
arm key
OG001
arm label
Atezolizumab
regimen
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
analyzed count
144
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01903993-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
NCT01903993
outcome key
om-0003
arm key
OG000
arm label
Docetaxel
regimen
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01903993-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
NCT01903993
outcome key
om-0003
arm key
OG001
arm label
Atezolizumab
regimen
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01903993-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
NCT01903993
outcome key
om-0004
arm key
OG000
arm label
Atezolizumab
regimen
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
analyzed count
144
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01903993-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
NCT01903993
outcome key
om-0005
arm key
OG000
arm label
Atezolizumab
regimen
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
analyzed count
144
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01903993-om-0005#groups/OG000

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
NCT01903993
harm key
EG000
source section id
NCT01903993-ae
event group key
EG000
event group label
Docetaxel
serious affected
46
serious at risk
135
other affected
125
other at risk
135
frequency threshold
5
collection period
From the first study drug to the data cutoff date: 31 August 2018
event definition
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
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
NCT01903993
harm key
EG001
source section id
NCT01903993-ae
event group key
EG001
event group label
Atezolizumab
serious affected
53
serious at risk
142
other affected
127
other at risk
142
frequency threshold
5
collection period
From the first study drug to the data cutoff date: 31 August 2018
event definition
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
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

setting source links

Preserved source evidence · Not medical advice