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← Tecentriq Hybreza: Non-small cell lung cancer with PD-L1 stated without a specific alteration (adjuvant) after prior therapy

NCT02367781 · STUDY IN CONTEXT

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell L

Draft scope assessment: unclear. Attached because the study's own record names PD-L1. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first in the ITT-WT population.

The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation.

→

primary · POSTED

OS is defined as the time between the date of randomization and date of death from any cause in the ITT-WT population.

The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation.

→

secondary · POSTED

PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.

ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population

→

secondary · POSTED

OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.

The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment.

→

secondary · POSTED

OS is defined as the time between the date of randomization and date of death from any cause in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.

PD-L1 Expression Population and PD-L1 Expression WT Population

→

secondary · POSTED

ORR (confirmation not required) is defined as the proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by the investigator in the ITT-WT population.

The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT 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-tecentriq-hybreza-cba0c696
nct id
NCT02367781
qol key
qol-0010
source section id
NCT02367781-om-0010
source outcome index
10
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population
measure definition
Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales.
time frame
Up to approximately 35 months after first subject enrolled
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Patient-reported symptom or function measure · Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale

Score direction: Lower 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-tecentriq-hybreza-cba0c696
nct id
NCT02367781
qol key
qol-0011
source section id
NCT02367781-om-0011
source outcome index
11
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient-reported' in the study's own wording
scale title
Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale
measure definition
Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms \& are scored at individual symptom level, thus have a dyspnea score, chest pain score, \& cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 \& maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 \& 2, 'Cough' score is mean of question 3 \& 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea \& cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant.
time frame
Up to approximately 35 months after first subject enrolled
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
increase in score is suggestive of a worse
population note
Patient-reported outcome (PRO) analysis were conducted on either the ITT-WT population or the PRO-evaluable WT population, defined as participants randomized into the ITT-WT population who completed a given PRO questionnaire at the baseline visit and at least one post-baseline visit.
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-tecentriq-hybreza-cba0c696
nct id
NCT02367781
trial label
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell L
applicability
unclear
applicability note
Attached because the study's own record names PD-L1. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
3
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0000
    source section id
    NCT02367781-om-0000
    source outcome index
    0
    endpoint
    Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the ITT-WT Population
    endpoint definition
    PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first in the ITT-WT population.
    time origin
    Up to approximately 35 months after first patient enrolled
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation.
    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-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0001
    source section id
    NCT02367781-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS) in the ITT-WT Population
    endpoint definition
    OS is defined as the time between the date of randomization and date of death from any cause in the ITT-WT population.
    time origin
    Up to approximately 35 months after first patient enrolled
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation.
    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-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0002
    source section id
    NCT02367781-om-0002
    source outcome index
    2
    endpoint
    PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
    endpoint definition
    PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
    time origin
    Up to approximately 35 months after first subject enrolled
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
    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-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0003
    source section id
    NCT02367781-om-0003
    source outcome index
    3
    endpoint
    OS as Determined by the Investigator Using Recist v1.1 in the ITT Population
    endpoint definition
    OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
    time origin
    Up to approximately 41 months after first subject enrolled
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment.
    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-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0004
    source section id
    NCT02367781-om-0004
    source outcome index
    4
    endpoint
    OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT Population
    endpoint definition
    OS is defined as the time between the date of randomization and date of death from any cause in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
    time origin
    Up to approximately 35 months after first patient enrolled
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    PD-L1 Expression Population and PD-L1 Expression WT Population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0005
    source section id
    NCT02367781-om-0005
    source outcome index
    5
    endpoint
    Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population
    endpoint definition
    ORR (confirmation not required) is defined as the proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by the investigator in the ITT-WT population.
    time origin
    Up to approximately 41 months after first subject enrolled
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation
    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-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
    analyzed count
    456
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm B (Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
    analyzed count
    229
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
    analyzed count
    456
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm B (Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
    analyzed count
    229
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
    analyzed count
    483
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm B (Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
    analyzed count
    240
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
    analyzed count
    483
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm B (Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
    analyzed count
    240
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
    analyzed count
    230
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm B (Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
    analyzed count
    111
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
    analyzed count
    452
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Arm B (Nab-Paclitaxel+Carboplatin)
    regimen
    Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
    analyzed count
    227
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02367781-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    harm key
    EG000
    source section id
    NCT02367781-ae
    event group key
    EG000
    event group label
    Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
    serious affected
    252
    serious at risk
    473
    other affected
    467
    other at risk
    473
    frequency threshold
    5
    collection period
    From the first study drug to the data cutoff date: 18 January 2021 (approximately 69 months)
    event definition
    The safety-evaluable population included all treated participants, defined as randomized participants who received any protocol treatment. For the safety analyses, participants were grouped according to whether any full or partial dose of atezolizumab was received, including when atezolizumab was received in error. Specifically, for participants randomized to the CnP arm, if atezolizumab was received in error, the participants were grouped to the Atezo+CnP arm for the safety analyses.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    harm key
    EG001
    source section id
    NCT02367781-ae
    event group key
    EG001
    event group label
    Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin)
    serious affected
    63
    serious at risk
    131
    other affected
    127
    other at risk
    131
    frequency threshold
    5
    collection period
    From the first study drug to the data cutoff date: 18 January 2021 (approximately 69 months)
    event definition
    The safety-evaluable population included all treated participants, defined as randomized participants who received any protocol treatment. For the safety analyses, participants were grouped according to whether any full or partial dose of atezolizumab was received, including when atezolizumab was received in error. Specifically, for participants randomized to the CnP arm, if atezolizumab was received in error, the participants were grouped to the Atezo+CnP arm for the safety analyses.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    harm key
    EG002
    source section id
    NCT02367781-ae
    event group key
    EG002
    event group label
    Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy)
    serious affected
    24
    serious at risk
    101
    other affected
    100
    other at risk
    101
    frequency threshold
    5
    collection period
    From the first study drug to the data cutoff date: 18 January 2021 (approximately 69 months)
    event definition
    The safety-evaluable population included all treated participants, defined as randomized participants who received any protocol treatment. For the safety analyses, participants were grouped according to whether any full or partial dose of atezolizumab was received, including when atezolizumab was received in error. Specifically, for participants randomized to the CnP arm, if atezolizumab was received in error, the participants were grouped to the Atezo+CnP arm for the safety analyses.
    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-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    qol key
    qol-0010
    source section id
    NCT02367781-om-0010
    source outcome index
    10
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population
    measure definition
    Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales.
    time frame
    Up to approximately 35 months after first subject enrolled
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation.
    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-tecentriq-hybreza-cba0c696
    nct id
    NCT02367781
    qol key
    qol-0011
    source section id
    NCT02367781-om-0011
    source outcome index
    11
    instrument
    Patient-reported symptom or function measure
    instrument basis
    matched 'patient-reported' in the study's own wording
    scale title
    Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale
    measure definition
    Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms \& are scored at individual symptom level, thus have a dyspnea score, chest pain score, \& cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 \& maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 \& 2, 'Cough' score is mean of question 3 \& 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea \& cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant.
    time frame
    Up to approximately 35 months after first subject enrolled
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    increase in score is suggestive of a worse
    population note
    Patient-reported outcome (PRO) analysis were conducted on either the ITT-WT population or the PRO-evaluable WT population, defined as participants randomized into the ITT-WT population who completed a given PRO questionnaire at the baseline visit and at least one post-baseline visit.
    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