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

NCT02409342 · STUDY IN CONTEXT

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous N

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

OS is defined as the time from randomization to death from any cause.

Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).

→

primary · POSTED

OS is defined as the time from randomization to death from any cause.

Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).

→

secondary · POSTED

PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.

Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).

→

secondary · POSTED

PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.

Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).

→

secondary · POSTED

Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.

Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).

→

secondary · POSTED

Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.

Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).

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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

Patient-reported symptom or function measure · Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations

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-c88eb78e
nct id
NCT02409342
qol key
qol-0012
source section id
NCT02409342-om-0012
source outcome index
12
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient-reported' in the study's own wording
scale title
Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations
measure definition
TTD in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
time frame
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
increase in score suggested worse
population note
Analysis was performed for the TC3 or IC3-WT Populations.
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 as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations

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-c88eb78e
nct id
NCT02409342
qol key
qol-0013
source section id
NCT02409342-om-0013
source outcome index
13
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 as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
measure definition
Change from baseline in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
time frame
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
increase in score suggested worse
population note
Analysis was performed for the TC3 or IC3-WT Populations.
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 as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations

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-c88eb78e
nct id
NCT02409342
qol key
qol-0014
source section id
NCT02409342-om-0014
source outcome index
14
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations
measure definition
TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration (10-point change) in any of the following symptom subscales (cough, dyspnea \[multi-item scale\], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13. EORTC QLQ-LC13 module incorporates one multi-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
time frame
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Analysis was performed for the TC3 or IC3-WT Populations.
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-c88eb78e
nct id
NCT02409342
trial label
A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous N
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
2
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0000
    source section id
    NCT02409342-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS) in the TC3 or IC3-WT Populations
    endpoint definition
    OS is defined as the time from randomization to death from any cause.
    time origin
    From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
    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-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0001
    source section id
    NCT02409342-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
    endpoint definition
    OS is defined as the time from randomization to death from any cause.
    time origin
    From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
    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-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0002
    source section id
    NCT02409342-om-0002
    source outcome index
    2
    endpoint
    Progression-free Survival (PFS) in the TC3 or IC3-WT Populations
    endpoint definition
    PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
    time origin
    From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
    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-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0003
    source section id
    NCT02409342-om-0003
    source outcome index
    3
    endpoint
    Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
    endpoint definition
    PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
    time origin
    From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
    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-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0004
    source section id
    NCT02409342-om-0004
    source outcome index
    4
    endpoint
    Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations
    endpoint definition
    Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
    time origin
    Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 10 Sep 2018 (up to approximately 38 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
    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-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0005
    source section id
    NCT02409342-om-0005
    source outcome index
    5
    endpoint
    Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
    endpoint definition
    Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
    time origin
    Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 4 Feb 2020 (up to approximately 54.5 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).
    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-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
    regimen
    Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    98
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Atezolizumab
    regimen
    Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    107
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
    regimen
    Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    277
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Atezolizumab
    regimen
    Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    277
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
    regimen
    Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    98
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Atezolizumab
    regimen
    Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    107
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
    regimen
    Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    277
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Atezolizumab
    regimen
    Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    277
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
    regimen
    Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    98
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Atezolizumab
    regimen
    Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    107
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
    regimen
    Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    277
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Atezolizumab
    regimen
    Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
    analyzed count
    277
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02409342-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-tecentriq-c88eb78e
    nct id
    NCT02409342
    harm key
    EG000
    source section id
    NCT02409342-ae
    event group key
    EG000
    event group label
    Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
    serious affected
    77
    serious at risk
    263
    other affected
    230
    other at risk
    263
    frequency threshold
    5
    collection period
    From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
    event definition
    All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
    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-c88eb78e
    nct id
    NCT02409342
    harm key
    EG001
    source section id
    NCT02409342-ae
    event group key
    EG001
    event group label
    Atezolizumab
    serious affected
    97
    serious at risk
    286
    other affected
    238
    other at risk
    286
    frequency threshold
    5
    collection period
    From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
    event definition
    All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
    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-c88eb78e
    nct id
    NCT02409342
    qol key
    qol-0012
    source section id
    NCT02409342-om-0012
    source outcome index
    12
    instrument
    Patient-reported symptom or function measure
    instrument basis
    matched 'patient-reported' in the study's own wording
    scale title
    Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations
    measure definition
    TTD in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
    time frame
    Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    increase in score suggested worse
    population note
    Analysis was performed for the TC3 or IC3-WT Populations.
    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-c88eb78e
    nct id
    NCT02409342
    qol key
    qol-0013
    source section id
    NCT02409342-om-0013
    source outcome index
    13
    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 as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
    measure definition
    Change from baseline in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
    time frame
    Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    increase in score suggested worse
    population note
    Analysis was performed for the TC3 or IC3-WT Populations.
    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-c88eb78e
    nct id
    NCT02409342
    qol key
    qol-0014
    source section id
    NCT02409342-om-0014
    source outcome index
    14
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations
    measure definition
    TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration (10-point change) in any of the following symptom subscales (cough, dyspnea \[multi-item scale\], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13. EORTC QLQ-LC13 module incorporates one multi-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
    time frame
    Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Analysis was performed for the TC3 or IC3-WT Populations.
    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