Triple-negative Breast Cancer
Conditions
Brief summary
This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).
Interventions
Atezolizumab was administered as per schedule described in respective arm.
DRUGPlacebo
Placebo matched to atezolizumab was administered as per schedule described in respective arm.
DRUGNab-paclitaxel
Nab-paclitaxel was administered as per schedule described in the arms.
DRUGDoxorubicin
Doxorubicin was administered as per schedule described in the arms.
DRUGCyclophosphamide
Cyclophosphamide was administered as per schedule described in the arms.
DRUGFilgrastim
Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
DRUGPegfilgrastim
Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically documented TNBC (negative human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PgR\] status) * Confirmed tumor programmed death-ligand 1 (PD-L1) evaluation as documented through central testing of a representative tumor tissue specimen * Primary breast tumor size of greater than (\>) 2 centimeters (cm) by at least one radiographic or clinical measurement * Stage at presentation: cT2-cT4, cN0-cN3, cM0 * Participant agreement to undergo appropriate surgical management including axillary lymph node surgery and partial or total mastectomy after completion of neoadjuvant treatment * Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>=) 53 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans * Adequate hematologic and end-organ function * Representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides, with an associated pathology report documenting ER, PgR, and HER2 negativity * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm * Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
Exclusion criteria
* Prior history of invasive breast cancer * Stage 4 (metastatic) breast cancer * Prior systemic therapy for treatment and prevention of breast cancer * Previous therapy with anthracyclines or taxanes for any malignancy * History of ductal carcinoma in situ (DCIS), except for participants treated exclusively with mastectomy \>5 years prior to diagnosis of current breast cancer * History of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed \>5 years prior to diagnosis of current breast cancer * Bilateral breast cancer * Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes * Axillary lymph node dissection prior to initiation of neoadjuvant therapy * History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death * Cardiopulmonary dysfunction * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells * Known allergy or hypersensitivity to the components of the formulations of atezolizumab, nab-paclitaxel, cyclophosphamide, or doxorubicin, filgrastim or pegfilgrastim * Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus, and dermatologic manifestations of eczema, psoriasis, lichen simplex chronicus, or vitiligo (e.g., participants with psoriatic arthritis are excluded) * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted * Positive human immunodeficiency virus (HIV) test at screening * Active hepatitis B and hepatitis C virus infection * Active tuberculosis * Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, except prophylactic antibiotics * Major surgical procedure within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study * Prior allogeneic stem cell or solid organ transplantation * Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications * Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint-blockade therapies, including anti-cluster of differentiation 40 (anti-CD40), anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies * Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment * Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medications during the study * History of cerebrovascular accident within 12 months prior to randomization * Pregnant or lactating, or intending to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population | After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020 | Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR. |
| Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System | After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020 | Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell \[IC\] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) in All Participants Who Undergo Surgery | From surgery and up to study final analysis data cut off on 28 September 2022. | Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants. |
| Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery | From surgery and up to study final analysis data cut off on 28 September 2022. | Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for the subpopulation of participants with PD-L1-positive tumor status. |
| Overall Survival (OS) in All Participants | From randomization and up to study final analysis data cut off on 28 September 2022. | Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants. |
| Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status | From randomization and up to study final analysis data cut off on 28 September 2022. | Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status. |
| Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | From randomization and up to study final analysis data cut off on 28 September 2022. | Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). |
| Event-Free Survival (EFS) in All Participants | From randomization and up to study final analysis data cut off on 28 September 2022. | Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease. |
| Percentage of Participants With at Least One Adverse Events (AEs) | From randomization and up to study final analysis data cut off on 28 September 2022. | Percentage of participants with at least one adverse event. |
| Minimum Observed Serum Atezolizumab Concentration (Cmin) | Pre-dose on Day 1 of Cycles 2, 3, 4, 6, 8, 12, and 16 (cycle length = 28 days from Cycles 1 to 5, and 21 days from Cycles 6 to 16) | Minimum observed serum atezolizumab concentration. |
| Maximum Observed Serum Atezolizumab Concentration (Cmax) | Day 1 of Cycle 1 post dose (cycle length = 28 days) | Maximum observed atezolizumab concentration (Cmax). |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | Baseline up to approximately 20 months | Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab. |
| Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | From randomization and up to study final analysis data cut off on 28 September 2022. | Mean change from baseline score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). |
| Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status | From randomization and up to study final analysis data cut off on 28 September 2022. | Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease. |
Countries
Australia, Belgium, Brazil, Canada, Germany, Italy, Japan, Poland, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo and Chemotherapy Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\^2) and cyclophosphamide (600 mg/m\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery. | 168 |
| Atezolizumab and Chemotherapy Participants received atezolizumab (840 milligrams \[mg\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \[mg/m\^2\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\^2) and cyclophosphamide (600 mg/m\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy. | 165 |
| Total | 333 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death due to any cause | 26 | 15 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 16 | 8 |
Baseline characteristics
| Characteristic | Atezolizumab and Chemotherapy | Total | Placebo and Chemotherapy |
|---|---|---|---|
| Age, Continuous | 50.1 Years STANDARD_DEVIATION 11.6 | 50.2 Years STANDARD_DEVIATION 12.4 | 50.3 Years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 92 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 114 Participants | 228 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 47 Participants | 88 Participants | 41 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 24 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 102 Participants | 210 Participants | 108 Participants |
| Sex: Female, Male Female | 165 Participants | 333 Participants | 168 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 28 / 167 | 16 / 164 |
| other Total, other adverse events | 167 / 167 | 162 / 164 |
| serious Total, serious adverse events | 36 / 167 | 59 / 164 |
Outcome results
Primary
Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
Time frame: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020
Population: ITT population (full population) is defined as all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo and Chemotherapy | Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population | 69 Number of Participants |
| Atezolizumab and Chemotherapy | Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population | 95 Number of Participants |
Comparison: Stratified analysis. Strata are: tumor PD-L1 status (IC0 vs. IC1/2/3) and clinical stage at presentation (Stage II vs. III).p-value: 0.004495% CI: [5.91, 27.1]Cochran-Mantel-Haenszel
Primary
Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell \[IC\] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
Time frame: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020
Population: PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo and Chemotherapy | Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System | 37 Number of Participants |
| Atezolizumab and Chemotherapy | Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System | 53 Number of Participants |
Comparison: Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).p-value: 0.020695% CI: [4.17, 34.83]Cochran-Mantel-Haenszel
Secondary
Disease-Free Survival (DFS) in All Participants Who Undergo Surgery
Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants.
Time frame: From surgery and up to study final analysis data cut off on 28 September 2022.
Population: ITT population (full population) is defined as all randomized participants. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo and Chemotherapy | Disease-Free Survival (DFS) in All Participants Who Undergo Surgery | NA Months |
| Atezolizumab and Chemotherapy | Disease-Free Survival (DFS) in All Participants Who Undergo Surgery | NA Months |
Comparison: Stratified analysis. Strata are: Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).95% CI: [0.44, 1.3]Stratified log-rank test
Secondary
Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery
Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for the subpopulation of participants with PD-L1-positive tumor status.
Time frame: From surgery and up to study final analysis data cut off on 28 September 2022.
Population: PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS in the Subpopulation of Participants with PD-L1-Positive Tumor Status.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo and Chemotherapy | Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery | NA Months |
| Atezolizumab and Chemotherapy | Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery | NA Months |
Comparison: Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).95% CI: [0.23, 1.43]Stratified log-rank test
Secondary
Event-Free Survival (EFS) in All Participants
Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Population: ITT population (full population) is defined as all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo and Chemotherapy | Event-Free Survival (EFS) in All Participants | NA Months |
| Atezolizumab and Chemotherapy | Event-Free Survival (EFS) in All Participants | NA Months |
Comparison: Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).95% CI: [0.47, 1.21]Stratified log-rank test
Secondary
Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status
Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Population: PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo and Chemotherapy | Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status | NA Months |
| Atezolizumab and Chemotherapy | Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status | NA Months |
Comparison: Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).95% CI: [0.26, 1.18]Stratified log-rank test
Secondary
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Maximum observed atezolizumab concentration (Cmax).
Time frame: Day 1 of Cycle 1 post dose (cycle length = 28 days)
Population: The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo and Chemotherapy | Maximum Observed Serum Atezolizumab Concentration (Cmax) | 334 µg/mL | Standard Deviation 63.3 |
Secondary
Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Mean change from baseline score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30).
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Population: All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 12 | -1.65 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 15 Day 1 | -4.24 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 12 Day 1 | -0.63 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 16 Day 1 | -2.42 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 18 | -0.98 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Study Drug Completion/Early Discontinuation | -5.58 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle Cycle 5 Day 1 | -17.06 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 3 | -4.16 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 24 | 1.31 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 6 | -5.21 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 13 Day 1 | -1.26 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 9 | -3.97 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 30 | -2.18 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 12 | -4.43 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 8 Day 1 | 0.77 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 18 | -4.90 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 36 | -1.08 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 24 | -4.07 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 14 Day 1 | -1.05 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 30 | -3.36 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 48 | -25.00 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 36 | -4.06 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 4 Day 1 | -14.49 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 48 | -3.33 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 2 Day 1 | -6.37 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 2 Day 1 | -8.08 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 15 Day 1 | 0.00 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 3 Day 1 | -19.54 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 3 Day 1 | -12.17 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 4 Day 1 | -28.29 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 9 Day 1 | -0.28 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 5 Day 1 | -32.99 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 4 Day 1 | -19.48 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 6 Day 1 | -22.39 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 16 Day 1 | 2.10 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 7 Day 1 | -14.21 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 5 Day 1 | -21.59 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 8 Day 1 | -10.50 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 6 Day 1 | -2.49 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 9 Day 1 | -10.74 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 6 Day 1 | -10.20 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 10 Day 1 | -9.36 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Study Drug Completion/ Early Discontinuation | 0.06 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 11 Day 1 | -8.26 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 7 Day 1 | -7.43 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 12 Day 1 | -6.86 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 10 Day 1 | -1.17 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 13 Day 1 | -6.30 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 8 Day 1 | -4.80 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 14 Day 1 | -7.28 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 3 | 0.64 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 15 Day 1 | -8.63 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 9 Day 1 | -5.40 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 16 Day 1 | -4.65 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 3 Day 1 | -12.72 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Study Drug Completion/Early Discontinuation | -8.46 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 10 Day 1 | -4.87 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 3 | -5.98 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 6 | -2.00 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 6 | -10.67 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 11 Day 1 | -3.99 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 9 | -7.61 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 11 Day 1 | 0.35 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 12 | -7.66 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 12 Day 1 | -2.59 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 18 | -7.03 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 9 | -0.93 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 24 | -9.96 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 13 Day 1 | -3.63 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 30 | -8.72 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 7 Day 1 | -0.61 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 36 | -5.65 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 14 Day 1 | -3.42 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 48 | -16.67 Score on a 0-100 scale. |
| Placebo and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 2 Day 1 | -4.62 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 48 | -21.43 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 2 Day 1 | -7.91 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 3 Day 1 | -17.07 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 4 Day 1 | -19.80 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle Cycle 5 Day 1 | -26.02 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 6 Day 1 | -8.78 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 7 Day 1 | -5.40 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 8 Day 1 | -6.69 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 9 Day 1 | -6.13 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 10 Day 1 | -8.40 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 11 Day 1 | -7.04 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 12 Day 1 | -6.56 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 13 Day 1 | -5.85 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 14 Day 1 | -7.47 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 15 Day 1 | -4.67 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 16 Day 1 | -3.73 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Study Drug Completion/ Early Discontinuation | -6.20 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 3 | -6.57 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 6 | -3.37 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 9 | -4.42 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 12 | -4.50 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 18 | -4.17 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 24 | -6.17 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 30 | -9.14 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 36 | -5.56 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 48 | -21.43 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 2 Day 1 | -5.73 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 3 Day 1 | -12.90 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 4 Day 1 | -21.68 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 5 Day 1 | -26.43 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 6 Day 1 | -12.20 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 7 Day 1 | -8.96 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 8 Day 1 | -7.70 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 9 Day 1 | -5.74 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 10 Day 1 | -6.17 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 11 Day 1 | -5.73 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 12 Day 1 | -6.61 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 13 Day 1 | -6.72 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 14 Day 1 | -5.07 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 15 Day 1 | -5.89 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 16 Day 1 | -5.79 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Study Drug Completion/Early Discontinuation | -8.66 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 3 | -8.54 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 6 | -6.91 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 9 | -7.78 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 12 | -7.46 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 18 | -6.61 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 24 | -6.30 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 30 | -10.46 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 36 | -8.70 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 48 | -11.43 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 2 Day 1 | -12.42 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 3 Day 1 | -19.84 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 4 Day 1 | -33.56 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 5 Day 1 | -38.97 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 6 Day 1 | -26.14 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 7 Day 1 | -18.36 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 8 Day 1 | -14.89 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 9 Day 1 | -13.80 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 10 Day 1 | -13.39 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 11 Day 1 | -12.98 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 12 Day 1 | -13.52 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 13 Day 1 | -14.46 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 14 Day 1 | -13.82 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 15 Day 1 | -11.78 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 16 Day 1 | -10.82 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Study Drug Completion/Early Discontinuation | -16.42 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 3 | -14.44 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 6 | -13.97 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 9 | -13.76 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 12 | -12.83 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 18 | -12.05 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 24 | -10.96 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 30 | -16.44 Score on a 0-100 scale. |
| Atezolizumab and Chemotherapy | Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 36 | -12.56 Score on a 0-100 scale. |
Secondary
Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms).
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Population: All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 24 | 78.31 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 9 Day 1 | 84.19 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 10 Day 1 | 84.78 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 12 Day 1 | 86.97 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Baseline | 76.45 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 2 Day 1 | 71.90 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 3 Day 1 | 65.30 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 4 Day 1 | 62.36 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle Cycle 5 Day 1 | 60.37 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 6 Day 1 | 74.25 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 7 Day 1 | 76.50 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 8 Day 1 | 77.17 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 9 Day 1 | 75.62 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 10 Day 1 | 75.22 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 11 Day 1 | 75.98 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 12 Day 1 | 75.84 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 13 Day 1 | 74.72 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 14 Day 1 | 74.79 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 15 Day 1 | 75.00 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 16 Day 1 | 77.70 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Study Drug Completion/ Early Discontinuation | 75.38 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 3 | 76.97 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 6 | 74.93 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 9 | 75.00 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 12 | 75.15 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 18 | 76.39 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 30 | 78.33 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 36 | 78.63 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 48 | 58.33 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Baseline | 90.03 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 2 Day 1 | 83.50 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 3 Day 1 | 78.33 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 4 Day 1 | 70.42 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 5 Day 1 | 67.91 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 6 Day 1 | 79.49 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 7 Day 1 | 82.73 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 8 Day 1 | 85.15 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 11 Day 1 | 85.48 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 13 Day 1 | 86.16 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 14 Day 1 | 86.22 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 15 Day 1 | 84.69 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 16 Day 1 | 87.19 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Drug Completion/Early Discontinuation | 84.21 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 3 | 85.29 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 6 | 84.96 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 9 | 85.11 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 12 | 85.05 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 18 | 85.23 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 24 | 85.69 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 30 | 87.08 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 36 | 86.24 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 48 | 90.00 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Baseline | 88.86 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 2 Day 1 | 80.39 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 3 Day 1 | 70.39 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 4 Day 1 | 61.11 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 5 Day 1 | 56.06 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 6 Day 1 | 66.17 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 7 Day 1 | 73.77 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 8 Day 1 | 77.59 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 9 Day 1 | 77.13 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 10 Day 1 | 78.51 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 11 Day 1 | 79.97 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 12 Day 1 | 81.79 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 13 Day 1 | 81.79 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 14 Day 1 | 80.81 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 15 Day 1 | 79.02 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 16 Day 1 | 83.03 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Study Drug Completion/Early Discontinuation | 80.00 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 3 | 81.93 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 6 | 78.53 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 9 | 81.61 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 12 | 81.68 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 18 | 81.86 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 24 | 79.47 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 30 | 81.54 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 36 | 85.48 Score on a 0-100 scale |
| Placebo and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 48 | 83.33 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 7 Day 1 | 69.92 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 14 Day 1 | 84.96 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Study Drug Completion/Early Discontinuation | 74.09 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 15 Day 1 | 84.28 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 8 Day 1 | 72.95 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Baseline | 79.24 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 16 Day 1 | 84.33 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 2 Day 1 | 71.55 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 18 | 77.98 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 3 Day 1 | 62.65 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Drug Completion/Early Discontinuation | 82.34 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 4 Day 1 | 59.84 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 9 Day 1 | 74.32 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle Cycle 5 Day 1 | 53.60 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 3 | 82.35 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 6 Day 1 | 70.14 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 3 | 75.47 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 7 Day 1 | 73.57 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 6 | 84.17 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 8 Day 1 | 72.06 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 10 Day 1 | 75.27 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 9 Day 1 | 72.18 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 9 | 83.48 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 10 Day 1 | 70.56 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 48 | 76.19 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 11 Day 1 | 71.93 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 12 | 83.17 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 12 Day 1 | 72.40 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 11 Day 1 | 75.68 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 13 Day 1 | 72.87 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 18 | 84.29 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 14 Day 1 | 71.19 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 6 | 76.10 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 15 Day 1 | 74.07 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 24 | 85.43 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Cycle 16 Day 1 | 74.93 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 12 Day 1 | 75.14 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Study Drug Completion/ Early Discontinuation | 72.51 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 30 | 84.54 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 3 | 72.65 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 24 | 80.09 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 6 | 75.61 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 36 | 85.80 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 9 | 75.19 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 13 Day 1 | 74.38 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 12 | 74.87 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Survival Follow-Up Month 48 | 88.57 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 18 | 75.60 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 24 | 74.46 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 9 | 76.39 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 30 | 73.50 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Baseline | 89.44 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 36 | 76.93 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 14 Day 1 | 75.50 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | GHS/QoL Survival Follow-Up Month 48 | 63.10 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 2 Day 1 | 77.18 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Baseline | 90.85 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 36 | 81.64 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 2 Day 1 | 84.93 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 3 Day 1 | 69.48 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 3 Day 1 | 77.29 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 15 Day 1 | 77.59 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 4 Day 1 | 69.02 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 4 Day 1 | 56.60 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 5 Day 1 | 64.27 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 12 | 76.98 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 6 Day 1 | 78.01 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 5 Day 1 | 51.08 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 7 Day 1 | 80.78 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 16 Day 1 | 78.65 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 8 Day 1 | 81.75 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 9 Day 1 | 83.99 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 10 Day 1 | 83.88 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Cycle 6 Day 1 | 62.88 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 11 Day 1 | 84.24 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 12 Day 1 | 83.44 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Role Functioning Survival Follow-Up Month 30 | 78.24 Score on a 0-100 scale |
| Atezolizumab and Chemotherapy | Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30 | Physical Functioning Cycle 13 Day 1 | 83.36 Score on a 0-100 scale |
Secondary
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Minimum observed serum atezolizumab concentration.
Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4, 6, 8, 12, and 16 (cycle length = 28 days from Cycles 1 to 5, and 21 days from Cycles 6 to 16)
Population: The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo and Chemotherapy | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Cycle 2 Day 1 | 142 µg/mL | Standard Deviation 54.3 |
| Placebo and Chemotherapy | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Cycle 3 Day 1 | 189 µg/mL | Standard Deviation 64.2 |
| Placebo and Chemotherapy | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Cycle 4 Day 1 | 207 µg/mL | Standard Deviation 77.3 |
| Placebo and Chemotherapy | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Cycle 6 Day 1 | 78.7 µg/mL | Standard Deviation 50.3 |
| Placebo and Chemotherapy | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Cycle 8 Day 1 | 204 µg/mL | Standard Deviation 62.7 |
| Placebo and Chemotherapy | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Cycle 12 Day 1 | 267 µg/mL | Standard Deviation 81.1 |
| Placebo and Chemotherapy | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Cycle 16 Day 1 | 303 µg/mL | Standard Deviation 89.1 |
Secondary
Overall Survival (OS) in All Participants
Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants.
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Population: ITT population (full population) is defined as all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo and Chemotherapy | Overall Survival (OS) in All Participants | NA Months |
| Atezolizumab and Chemotherapy | Overall Survival (OS) in All Participants | NA Months |
Comparison: Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).95% CI: [0.3, 1.04]Stratified log-rank test
Secondary
Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status
Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status.
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Population: PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo and Chemotherapy | Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status | NA Months |
| Atezolizumab and Chemotherapy | Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status | NA Months |
Comparison: Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).95% CI: [0.26, 1.91]Stratified log-rank test
Secondary
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab.
Time frame: Baseline up to approximately 20 months
Population: The anti-drug antibodies (ADA)-evaluable population is defined as all participants treated with atezolizumab who have at least one post-baseline ADA result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo and Chemotherapy | Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | Post-baseline evaluable participants | 13.4 Percentage of participants |
| Placebo and Chemotherapy | Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | Baseline evaluable participants | 2.5 Percentage of participants |
Secondary
Percentage of Participants With at Least One Adverse Events (AEs)
Percentage of participants with at least one adverse event.
Time frame: From randomization and up to study final analysis data cut off on 28 September 2022.
Population: Safety population is defined as all participants who received any dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo and Chemotherapy | Percentage of Participants With at Least One Adverse Events (AEs) | 100 Percentage of participants |
| Atezolizumab and Chemotherapy | Percentage of Participants With at Least One Adverse Events (AEs) | 100 Percentage of participants |