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← Tecentriq Hybreza: metastatic Non-small cell lung cancer with PD-L1 stated without a specific alteration, EGFR stated without a specific alteration, ALK stated without a specific a

NCT02366143 · STUDY IN CONTEXT

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage

Draft scope assessment: unclear. Attached because the study's own record names PD-L1 and 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

Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.

Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

→

primary · POSTED

Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population

ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

→

primary · POSTED

Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population

ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

→

secondary · POSTED

PFS, as determined by the independent review facility (IRF) Using RECIST v1.1 in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.

Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

→

secondary · POSTED

PFS, as determined by the investigator according to RECIST v1.1, in Arm B versus C in the Teff high population and ITT population.

Teff-high population is defined as the patients in the ITT population with Teff signature expression \>=-1.91. ITT population is defined as all randomized patients, regardless of receipt of the assigned treatment.

→

secondary · POSTED

PFS, as determined by the investigator according to RECIST v1.1, in Arm A versus B in the Teff high-WT population and ITT-WT population.

Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients 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 Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
nct id
NCT02366143
qol key
qol-0016
source section id
NCT02366143-om-0016
source outcome index
16
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 Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
measure definition
EORTC QLQ-C30 is a validated \& reliable self-report measure (Aaronson et al.1993;Fitzsimmons et al.1999) that consists of 30 questions that assess 5 aspects of patient functioning (physical,emotional,role, cognitive,and social), 3 symptom scales (fatigue,nausea \& vomiting, pain),global health/quality of life,and six single items (dyspnea,insomnia, appetite loss,constipation,diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life);however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al.1998).
time frame
Baseline up to approximately 29 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients 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 →
EORTC QLQ · TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
nct id
NCT02366143
qol key
qol-0017
source section id
NCT02366143-om-0017
source outcome index
17
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
measure definition
QLQ-LC13 Quality-of-Life Questionnaire Lung Cancer Module incorporates one multiple-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
time frame
Baseline up to approximately 29 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients 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-2a1c5590
nct id
NCT02366143
qol key
qol-0018
source section id
NCT02366143-om-0018
source outcome index
18
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
The SILC (Symptoms in Lung Cancer) scale was used to assess patient-reported severity of lung cancer symptoms (chest pain, dyspnea, and cough). The SILC scale is a 9-item content validated self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a symptom severity score. The SILC questionnaire comprises three individual symptoms (dyspnea, cough, chest pain) and are scored at the individual symptom level, thus have a dyspnea score, chest pain score, and cough score. Each individual symptom score is calculated as the average of responses for the symptom items \[e.g. Chest Pain Score=mean (item 1; item 2)\]. An increase in score is suggestive of a worsening in symptomology (i.e. frequency or severity). A score change of ≥0.3 points for the dyspnea and cough symptom scores is considered to be clinically significant; whereas a score change of ≥0.5 points for the chest pain score is considered to be clinically significant.
time frame
Baseline up to approximately 29 months
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
increase in score is suggestive of a worse
population note
No participants were analyzed due to psychometric properties within the NSCLC population are still being determined. Due to quality issues data not analyzed.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
nct id
NCT02366143
trial label
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage
applicability
unclear
applicability note
Attached because the study's own record names PD-L1 and 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
3
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0000
    source section id
    NCT02366143-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population
    endpoint definition
    Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.
    time origin
    Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients 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-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0001
    source section id
    NCT02366143-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
    endpoint definition
    Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
    time origin
    Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT-WT population is defined as the ITT population excluding patients 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-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0002
    source section id
    NCT02366143-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
    endpoint definition
    Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
    time origin
    Baseline until death (up approximately 53 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT-WT population is defined as the ITT population excluding patients 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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0003
    source section id
    NCT02366143-om-0003
    source outcome index
    3
    endpoint
    PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population
    endpoint definition
    PFS, as determined by the independent review facility (IRF) Using RECIST v1.1 in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.
    time origin
    Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients 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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0004
    source section id
    NCT02366143-om-0004
    source outcome index
    4
    endpoint
    PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population
    endpoint definition
    PFS, as determined by the investigator according to RECIST v1.1, in Arm B versus C in the Teff high population and ITT population.
    time origin
    Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Teff-high population is defined as the patients in the ITT population with Teff signature expression \>=-1.91. ITT population is defined as all randomized patients, 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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0005
    source section id
    NCT02366143-om-0005
    source outcome index
    5
    endpoint
    PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
    endpoint definition
    PFS, as determined by the investigator according to RECIST v1.1, in Arm A versus B in the Teff high-WT population and ITT-WT population.
    time origin
    Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients 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-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
    regimen
    Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 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 until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
    analyzed count
    356
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm C (Bevacizumab+Paclitaxel+Carboplatin)
    regimen
    Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
    analyzed count
    336
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
    regimen
    Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 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 until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
    analyzed count
    359
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm C (Bevacizumab+Paclitaxel+Carboplatin)
    regimen
    Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
    analyzed count
    337
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm A (Atezolizumab+Paclitaxel+Carboplatin)
    regimen
    Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 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
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm C (Bevacizumab+Paclitaxel+Carboplatin)
    regimen
    Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
    analyzed count
    338
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
    regimen
    Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 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 until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
    analyzed count
    356
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm C (Bevacizumab+Paclitaxel+Carboplatin)
    regimen
    Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
    analyzed count
    336
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
    regimen
    Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 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 until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
    analyzed count
    400
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm C (Bevacizumab+Paclitaxel+Carboplatin)
    regimen
    Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
    analyzed count
    400
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Arm A (Atezolizumab+Paclitaxel+Carboplatin)
    regimen
    Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 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
    348
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
    regimen
    Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 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 until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
    analyzed count
    356
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02366143-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    harm key
    EG000
    source section id
    NCT02366143-ae
    event group key
    EG000
    event group label
    Arm C (Bev+CP)
    serious affected
    142
    serious at risk
    394
    other affected
    381
    other at risk
    394
    frequency threshold
    5
    collection period
    From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
    event definition
    The safety population included all treated participants, defined as randomized participants 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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    harm key
    EG001
    source section id
    NCT02366143-ae
    event group key
    EG001
    event group label
    Arm B (Atezo+Bev+CP)
    serious affected
    190
    serious at risk
    393
    other affected
    375
    other at risk
    393
    frequency threshold
    5
    collection period
    From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
    event definition
    The safety population included all treated participants, defined as randomized participants 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    harm key
    EG002
    source section id
    NCT02366143-ae
    event group key
    EG002
    event group label
    Arm A (Atezo+CP)
    serious affected
    170
    serious at risk
    400
    other affected
    385
    other at risk
    400
    frequency threshold
    5
    collection period
    From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
    event definition
    The safety population included all treated participants, defined as randomized participants 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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-hybreza-2a1c5590
    nct id
    NCT02366143
    qol key
    qol-0016
    source section id
    NCT02366143-om-0016
    source outcome index
    16
    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 Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
    measure definition
    EORTC QLQ-C30 is a validated \& reliable self-report measure (Aaronson et al.1993;Fitzsimmons et al.1999) that consists of 30 questions that assess 5 aspects of patient functioning (physical,emotional,role, cognitive,and social), 3 symptom scales (fatigue,nausea \& vomiting, pain),global health/quality of life,and six single items (dyspnea,insomnia, appetite loss,constipation,diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life);however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al.1998).
    time frame
    Baseline up to approximately 29 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients 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-2a1c5590
    nct id
    NCT02366143
    qol key
    qol-0017
    source section id
    NCT02366143-om-0017
    source outcome index
    17
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
    measure definition
    QLQ-LC13 Quality-of-Life Questionnaire Lung Cancer Module incorporates one multiple-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
    time frame
    Baseline up to approximately 29 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients 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-2a1c5590
    nct id
    NCT02366143
    qol key
    qol-0018
    source section id
    NCT02366143-om-0018
    source outcome index
    18
    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
    The SILC (Symptoms in Lung Cancer) scale was used to assess patient-reported severity of lung cancer symptoms (chest pain, dyspnea, and cough). The SILC scale is a 9-item content validated self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a symptom severity score. The SILC questionnaire comprises three individual symptoms (dyspnea, cough, chest pain) and are scored at the individual symptom level, thus have a dyspnea score, chest pain score, and cough score. Each individual symptom score is calculated as the average of responses for the symptom items \[e.g. Chest Pain Score=mean (item 1; item 2)\]. An increase in score is suggestive of a worsening in symptomology (i.e. frequency or severity). A score change of ≥0.3 points for the dyspnea and cough symptom scores is considered to be clinically significant; whereas a score change of ≥0.5 points for the chest pain score is considered to be clinically significant.
    time frame
    Baseline up to approximately 29 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    increase in score is suggestive of a worse
    population note
    No participants were analyzed due to psychometric properties within the NSCLC population are still being determined. Due to quality issues data not analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice