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This was a Phase II, open-label, prospective, multicenter study designed to evaluate the efficacy and safety of single-agent atezolizumab as a first-line therapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). In addition, the primary biomarker objective was to measure blood tumor mutational burden (bTMB) and evaluate whether it can predict for improved clinical outcome with atezolizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Experimental | Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab 1200 mg was administered by intravenous infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Determined by Investigator | Investigator-assessed objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1. | Baseline up to 32 months |
| Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator, by Positive Versus Negative bTMB Groups | Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first. | Baseline up to 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator | Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first. | Baseline up to 32 months |
| Duration of Response (DOR) Per RECIST v1.1 as Determined by Investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Central California Health Care System | Fresno | California | 93703 | United States | ||
| Memorial Regional Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35422531 | Derived | Kim ES, Velcheti V, Mekhail T, Yun C, Shagan SM, Hu S, Chae YK, Leal TA, Dowell JE, Tsai ML, Dakhil CSR, Stella P, Jin Y, Shames DS, Schleifman E, Fabrizio DA, Phan S, Socinski MA. Blood-based tumor mutational burden as a biomarker for atezolizumab in non-small cell lung cancer: the phase 2 B-F1RST trial. Nat Med. 2022 May;28(5):939-945. doi: 10.1038/s41591-022-01754-x. Epub 2022 Apr 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab | Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 29, 2019 | Apr 15, 2020 |
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|
Investigator-assessed DOR by RECIST v1.1 was defined as the time from initial occurrence of documented CR or PR until documented disease progression as determined by the investigator, or death, whichever occurred first. |
| Baseline up to 32 months |
| Disease Control Rate (DCR) Per RECIST v1.1 as Determined by Investigator | Confirmed disease control rate (cDCR) was defined as the rate of patients with CR or PR as the best response, or SD maintained for 24 weeks, per RECIST v1.1. | Baseline up to 32 months |
| Overall Survival (OS) | OS was defined as the time from the first dose of study drug to the time of death from any cause during the study. | From baseline until death (up to 32 months) |
| Percentage of Participants With Adverse Events | Adverse events were defined as any untoward medical occurrence in a subject administered atezolizumab, regardless of causal attribution. | Baseline up to 32 months |
| Percentage of Participants Who Are Alive and Progression-Free (Per RECIST v1.1) at 6, 9, 12, and 18 Months by Various bTMB Quantiles | A summary of the number of patients at risk and survival rate for the time points of 6, 9, 12, and 18 months. | Months 6, 9, 12, and 18 |
| OS by Various bTMB Cutoff Points 16 and 20 | OS was defined as the time from the first dose of study drug to the time of death from any cause during the study. | From baseline until death (up to 32 months) |
| Percentage of Participants With Objective Response (Per RECIST v1.1) by Various bTMB Quantiles | Objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1. | Baseline up to 32 months |
| Hollywood |
| Florida |
| 33021 |
| United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| St. Alexius Medical Center | Hoffman Estates | Illinois | 60169 | United States |
| Quincy Medical Group; Canc Ctr at Blessing Hosp | Quincy | Illinois | 62301 | United States |
| Franciscan St. Francis Health; Research Services | Indianapolis | Indiana | 46237 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Michigan Cancer Rsch Cons | Ypsilanti | Michigan | 48197 | United States |
| Virginia Piper Cancer Inst | Minneapolis | Minnesota | 55407 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Eastchester Center for Cancer Care | The Bronx | New York | 10469 | United States |
| Levine Cancer Institute-Carolinas Medical Center; Levine Cancer Institute-Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Cancer Treatment Centers of America - Eastern Regional Medical Center | Philadelphia | Pennsylvania | 19124 | United States |
| Avera Research Institute | Sioux Falls | South Dakota | 57105 | United States |
| Univ of Texas SW Medical Ctr | Dallas | Texas | 75390 | United States |
| Inova Health Care Services | Falls Church | Virginia | 22042 | United States |
| Western WA Oncology Inc PS | Lacey | Washington | 98503 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab | Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Determined by Investigator | Investigator-assessed objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1. | Efficacy and Safety analysis Population included participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline up to 32 months |
|
|
| |||||||||||||||||||||||||
| Primary | Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator, by Positive Versus Negative bTMB Groups | Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first. | Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >= 1%. | Posted | Median | 95% Confidence Interval | Months | Baseline up to 32 months |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator | Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first. | Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab. | Posted | Median | 95% Confidence Interval | Months | Baseline up to 32 months |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per RECIST v1.1 as Determined by Investigator | Investigator-assessed DOR by RECIST v1.1 was defined as the time from initial occurrence of documented CR or PR until documented disease progression as determined by the investigator, or death, whichever occurred first. | Duration of response included a subset of participants who achieved an objective response in the efficacy evaluable population. | Posted | Number | 95% Confidence Interval | Months | Baseline up to 32 months |
|
| ||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) Per RECIST v1.1 as Determined by Investigator | Confirmed disease control rate (cDCR) was defined as the rate of patients with CR or PR as the best response, or SD maintained for 24 weeks, per RECIST v1.1. | Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab. | Posted | Number | 95% Confidence Interval | Percentage | Baseline up to 32 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the first dose of study drug to the time of death from any cause during the study. | Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab. | Posted | Median | 95% Confidence Interval | Months | From baseline until death (up to 32 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | Adverse events were defined as any untoward medical occurrence in a subject administered atezolizumab, regardless of causal attribution. | Safety analyses population included all participants who received at least one dose of study drug. | Posted | Number | Percentage of Participants | Baseline up to 32 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Are Alive and Progression-Free (Per RECIST v1.1) at 6, 9, 12, and 18 Months by Various bTMB Quantiles | A summary of the number of patients at risk and survival rate for the time points of 6, 9, 12, and 18 months. | Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >=1%. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Months 6, 9, 12, and 18 |
| |||||||||||||||||||||||||||
| Secondary | OS by Various bTMB Cutoff Points 16 and 20 | OS was defined as the time from the first dose of study drug to the time of death from any cause during the study. | Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >= 1%. | Posted | Median | 95% Confidence Interval | Months | From baseline until death (up to 32 months) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (Per RECIST v1.1) by Various bTMB Quantiles | Objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1. | Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >=1%. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline up to 32 months |
|
Baseline up to approximately 3 years (data cut off 26 July 2019).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atezolizumab | Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment). | 85 | 152 | 81 | 152 | 146 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pulmonary artery occlusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2018 | Apr 15, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
Blood tumor mutational burden (bTMB) <20. |
| OG005 | bTMB >=20 | Blood tumor mutational burden (bTMB) >=20. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| bTMF <20 |
Blood tumor mutational burden (bTMB) <20. |
| OG005 | bTMF >=20 | Blood tumor mutational burden (bTMB) >=20. |
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