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This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant therapy consisted of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy consisted of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy. All participants who undergo surgery entered a surveillance period, which consisted of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants were monitored for disease recurrence and survival for up to 3 years after last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Experimental | Participants received two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrated clinical benefit were eligible to receive up to 12 months of atezolizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody | Drug | Atezolizumab was given as 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Major Pathologic Response (MPR) | Major pathologic response was defined as ≤10% of viable tumor cells as scored by a pathologist, based on surgical resection as defined by prior studies. Percentages have been rounded off to the nearest decimal point. | After surgery (approximately 10 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) for PD-L1-Positive Versus PD-L1-Negative Participants | ORR was defined as percentage of participants with complete response (CR) or partial response (PR) as determined by the investigator using RECIST v.1.1, assessed in the programmed death ligand 1 (PD-L1) positive (participants with combined tumor cell (TC)/ immune cell (IC) score categorized as TC1/2/3 or IC1/2/3) and PD-L1 negative (participants with TC/IC score was categorized as TC0 and IC0) groups. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages have been rounded off to the nearest decimal point. |
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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 |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States | ||
| UCLA Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38070597 | Derived | Dacic S, Travis WD, Giltnane JM, Kos F, Abel J, Hilz S, Fujimoto J, Sholl L, Ritter J, Khalil F, Liu Y, Taylor-Weiner A, Resnick M, Yu H, Hirsch FR, Bunn PA Jr, Carbone DP, Rusch V, Kwiatkowski DJ, Johnson BE, Lee JM, Hennek SR, Wapinski I, Nicholas A, Johnson A, Schulze K, Kris MG, Wistuba II. Artificial Intelligence-Powered Assessment of Pathologic Response to Neoadjuvant Atezolizumab in Patients With NSCLC: Results From the LCMC3 Study. J Thorac Oncol. 2024 May;19(5):719-731. doi: 10.1016/j.jtho.2023.12.010. Epub 2023 Dec 7. | |
| 36097216 |
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A total of 181 participants diagnosed with Stage IB, II, IIIA, or selected IIIB resectable and untreated non-small-cell lung cancer (NSCLC) took part in the study in the United States from 20 Apr 2017 to 05 Sep 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab | Participants received atezolizumab, 1200 milligram (mg) as intravenous (IV) infusion, once every 21 days (Q21D) for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months. |
| 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 | Feb 15, 2022 | Aug 16, 2024 |
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|
| Pre-surgery (Day 36 +/- 3 days), after 2 doses of neoadjuvant treatment with atezolizumab |
| Percentage of Participants With Major Pathologic Response for PD-L1-Positive Versus PD-L1-Negative Participants | Major pathologic response (MPR) was defined as ≤10% of viable tumor cells, as scored by a pathologist, based on surgical resection as defined by prior studies. MPR was assessed based on participants tumor cell (TC) and immune cell (IC) score. The participants were considered as PD-L1- positive if their combined TC/IC score was categorized as TC1/2/3 or IC1/2/3 and the participants were considered PD-L1 negative if TC/IC score was categorized as TC0 and IC0. Percentages have been rounded off to the nearest decimal point. | After surgery (approximately 10 weeks) |
| Number of Participants With at Least One Adverse Event | An adverse event (AE) was defined as any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0). | From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months) |
| Percentage of Participants With Major Pathologic Response (MPR) by Mutation Load | MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. Whole-exome sequencing (WES) was run, and the consequences of each mutation were determined using Ensembl Variant Effect Predictor (VEP). Mutation load (i.e. tumor mutation burden (TMB)) was defined as the number of variants altering protein sequence as outlined by VEP divided by 34 Megabase (MB) of assay target region. The final value was reported as number of mutations per megabase (mut/MB). It was divided into three groups: TMB <10 mut/MB; TMB ≥ 10 mut/MB to <16 mut/MB; and TMB ≥16 mut/MB. Percentages have been rounded off to the nearest decimal point. | Up to 13 weeks |
| Percentage of Participants With Major Pathologic Response (MPR) by Neoantigen Score | MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by neoantigen score, which was assessed based on the number of highly immunogenic, expressed neoantigens detected at baseline. Median splits were applied for analyses of MPR. Neoantigen scores >/= 73 (i.e. >/= 73 highly immunogenic, expressed neoantigens detected at baseline) were considered as high scores, and scores <73 (i.e. <73 highly immunogenic, expressed neoantigens detected at baseline) were considered as low neoantigen scores. Percentages have been rounded off to the nearest decimal point. | Up to 13 weeks |
| Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: Gene Set Variation Analysis (GSVA) | MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by gene set variation analysis (GSVA) scores. Bulk ribonucleic acid (RNA) from baseline tumor samples were assessed using GSVA for a T effector cell (Teff) signature comprising the following genes: cluster of differentiation 8A (CD8A), eomesodermin (EOMES), granzyme A (GZMA), T-box transcription factor 21 (TBX21), interferon-gamma (IFNG), granzyme B (GZMB), C-X-C motif chemokine ligand 9 (CXCL9), and C-X-C motif chemokine ligand 10 (CXCL10). Tertile splits were applied to GSVA scores, categorized as lower, middle, and upper scores, which indicated the relative levels of gene set expression in the baseline tumor samples. Percentages have been rounded off to the nearest decimal point. | Up to 13 weeks |
| Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: xCell Immune Score | MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by gene expression signatures. Bulk RNA from baseline tumor samples were assessed using xCell immune score. Tertile splits were applied to xCell immune scores, categorized as lower, middle, and upper scores, which indicated the relative levels of immune cell gene expression in the baseline tumor samples. Percentages have been rounded off to the nearest decimal point. | Up to 13 weeks |
| Santa Monica |
| California |
| 90404 |
| United States |
| University Of Colorado | Aurora | Colorado | 80045 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06520 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Emory University; Winship Cancer Institute | Atlanta | Georgia | 30308 | United States |
| Dana Farber Cancer Institute; Brigham and Womens Hospital | Boston | Massachusetts | 02115 | United States |
| Mass General/North Shore Cancer | Danvers | Massachusetts | 01923 | United States |
| Karmanos Cancer Inst; Hematology/Oncology | Detroit | Michigan | 48201 | United States |
| Washington University; Wash Uni. Sch. Of Med | St Louis | Missouri | 63110 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Memorial Sloan Kettering - Monmouth | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Cancer Center - Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center at Westchester | Harrison | New York | 10604 | United States |
| New York University Medical Center | New York | New York | 10036 | United States |
| Memorial Sloan Kettering - Basking Ridge | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | United States |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Derived |
| Chaft JE, Oezkan F, Kris MG, Bunn PA, Wistuba II, Kwiatkowski DJ, Owen DH, Tang Y, Johnson BE, Lee JM, Lozanski G, Pietrzak M, Seweryn M, Byun WY, Schulze K, Nicholas A, Johnson A, Grindheim J, Hilz S, Shames DS, Rivard C, Toloza E, Haura EB, McNamee CJ, Patterson GA, Waqar SN, Rusch VW, Carbone DP; LCMC study investigators. Neoadjuvant atezolizumab for resectable non-small cell lung cancer: an open-label, single-arm phase II trial. Nat Med. 2022 Oct;28(10):2155-2161. doi: 10.1038/s41591-022-01962-5. Epub 2022 Sep 12. |
| Participants Who Had Surgery |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all enrolled participants who have received any dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab | Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months. |
| 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 Major Pathologic Response (MPR) | Major pathologic response was defined as ≤10% of viable tumor cells as scored by a pathologist, based on surgical resection as defined by prior studies. Percentages have been rounded off to the nearest decimal point. | The Primary Efficacy Population (PEP) included NSCLC participants who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) mutant tumors. The overall number analyzed was the number of participants with data available for analysis. | Posted | Number | percentage of participants | After surgery (approximately 10 weeks) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) for PD-L1-Positive Versus PD-L1-Negative Participants | ORR was defined as percentage of participants with complete response (CR) or partial response (PR) as determined by the investigator using RECIST v.1.1, assessed in the programmed death ligand 1 (PD-L1) positive (participants with combined tumor cell (TC)/ immune cell (IC) score categorized as TC1/2/3 or IC1/2/3) and PD-L1 negative (participants with TC/IC score was categorized as TC0 and IC0) groups. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages have been rounded off to the nearest decimal point. | The overall number analyzed included participants in the PEP with non-missing ORR data and PD-L1 status. The PEP included participants with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row was the number of participants with data available for analysis in each PD-L1 group. | Posted | Number | 95% Confidence Interval | percentage of participants | Pre-surgery (Day 36 +/- 3 days), after 2 doses of neoadjuvant treatment with atezolizumab |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Pathologic Response for PD-L1-Positive Versus PD-L1-Negative Participants | Major pathologic response (MPR) was defined as ≤10% of viable tumor cells, as scored by a pathologist, based on surgical resection as defined by prior studies. MPR was assessed based on participants tumor cell (TC) and immune cell (IC) score. The participants were considered as PD-L1- positive if their combined TC/IC score was categorized as TC1/2/3 or IC1/2/3 and the participants were considered PD-L1 negative if TC/IC score was categorized as TC0 and IC0. Percentages have been rounded off to the nearest decimal point. | The overall number analyzed included participants in the PEP with non-missing MPR data and PD-L1 status. PEP included participants with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row was the number of participants with data available for analysis in each PD-L1 group. | Posted | Number | 95% Confidence Interval | percentage of participants | After surgery (approximately 10 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With at Least One Adverse Event | An adverse event (AE) was defined as any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0). | Safety population included all enrolled NSCLC participants who have received any dose of study drug. | Posted | Count of Participants | Participants | From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Pathologic Response (MPR) by Mutation Load | MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. Whole-exome sequencing (WES) was run, and the consequences of each mutation were determined using Ensembl Variant Effect Predictor (VEP). Mutation load (i.e. tumor mutation burden (TMB)) was defined as the number of variants altering protein sequence as outlined by VEP divided by 34 Megabase (MB) of assay target region. The final value was reported as number of mutations per megabase (mut/MB). It was divided into three groups: TMB <10 mut/MB; TMB ≥ 10 mut/MB to <16 mut/MB; and TMB ≥16 mut/MB. Percentages have been rounded off to the nearest decimal point. | The overall number analyzed included participants in the PEP with non-missing MPR and TMB data. The PEP included participants with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row is the number of participants with data available for analysis in each TMB subgroup. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 13 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Pathologic Response (MPR) by Neoantigen Score | MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by neoantigen score, which was assessed based on the number of highly immunogenic, expressed neoantigens detected at baseline. Median splits were applied for analyses of MPR. Neoantigen scores >/= 73 (i.e. >/= 73 highly immunogenic, expressed neoantigens detected at baseline) were considered as high scores, and scores <73 (i.e. <73 highly immunogenic, expressed neoantigens detected at baseline) were considered as low neoantigen scores. Percentages have been rounded off to the nearest decimal point. | The overall number analyzed included participants in the PEP with non-missing MPR and neoantigen score data. The PEP included those with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row is the number of participants with data available for analysis in each neoantigen score subgroup. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 13 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: Gene Set Variation Analysis (GSVA) | MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by gene set variation analysis (GSVA) scores. Bulk ribonucleic acid (RNA) from baseline tumor samples were assessed using GSVA for a T effector cell (Teff) signature comprising the following genes: cluster of differentiation 8A (CD8A), eomesodermin (EOMES), granzyme A (GZMA), T-box transcription factor 21 (TBX21), interferon-gamma (IFNG), granzyme B (GZMB), C-X-C motif chemokine ligand 9 (CXCL9), and C-X-C motif chemokine ligand 10 (CXCL10). Tertile splits were applied to GSVA scores, categorized as lower, middle, and upper scores, which indicated the relative levels of gene set expression in the baseline tumor samples. Percentages have been rounded off to the nearest decimal point. | The overall number analysed included participants in the PEP with non-missing MPR and GSVA score data. The PEP included participants with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row was the number of participants with data available for analysis in each GSVA score subgroup. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 13 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: xCell Immune Score | MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by gene expression signatures. Bulk RNA from baseline tumor samples were assessed using xCell immune score. Tertile splits were applied to xCell immune scores, categorized as lower, middle, and upper scores, which indicated the relative levels of immune cell gene expression in the baseline tumor samples. Percentages have been rounded off to the nearest decimal point. | The overall number analyzed included participants in the PEP with non-missing MPR and xCell immune score data. The PEP included participants with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row was the number of participants with data available for analysis in each xCell immune score subgroup. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 13 weeks |
|
Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
Not provided
| 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 atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months. | 39 | 181 | 63 | 181 | 168 | 181 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 23 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 23 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 23 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA version 23 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA version 23 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 23 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA version 23 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 23 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 23 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 23 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA version 23 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 23 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 23 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 23 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA version 23 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 23 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA version 23 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 23 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23 | Systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 23 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 23 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 23 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 23 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 23 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 23 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA version 23 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 23 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA version 23 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA version 23 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA version 23 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 23 | Systematic Assessment |
| |
| Vocal cord dysfunction | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 23 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 23 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA version 23 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 23 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 23 | Systematic Assessment |
| |
| Device leakage | Product Issues | MedDRA version 23 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 23 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 23 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 23 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 23 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 23 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 23 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 23 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 23 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 23 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 23 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 23 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 23 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 23 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 23 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 23 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 23 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 23 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 23 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 23 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 23 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 23 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 23 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 23 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 23 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 23 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 23 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 23 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 23 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 23 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 23 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 23 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA version 23 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 23 | 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 | Genentech | 800-821-8590 | genentech@druginfo.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2020 | Aug 16, 2024 | SAP_003.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 |
|
|
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| Participants |
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