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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003206-32 | EudraCT Number |
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This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Experimental | Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurred first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit. |
|
| Arm B (Nab-Paclitaxel+Carboplatin) | Active Comparator | Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurred first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody | Drug | Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Atezolizumab was administered to participants who were randomized to "Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)" and to participants in "Arm B (Nab-Paclitaxel + Carboplatin)" who cross over at progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the ITT-WT Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first in the ITT-WT population. | Up to approximately 35 months after first patient enrolled |
| Overall Survival (OS) in the ITT-WT Population | OS is defined as the time between the date of randomization and date of death from any cause in the ITT-WT population. | Up to approximately 35 months after first patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation. |
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Inclusion Criteria:
Exclusion Criteria:
Cancer-Specific Exclusions:
General Medical Exclusions:
Exclusion Criteria Related to Medications:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States | ||
| Kaiser Permanente Oakland Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36795388 | Derived | Socinski MA, Jotte RM, Cappuzzo F, Nishio M, Mok TSK, Reck M, Finley GG, Kaul MD, Yu W, Paranthaman N, Bara I, West HJ. Association of Immune-Related Adverse Events With Efficacy of Atezolizumab in Patients With Non-Small Cell Lung Cancer: Pooled Analyses of the Phase 3 IMpower130, IMpower132, and IMpower150 Randomized Clinical Trials. JAMA Oncol. 2023 Apr 1;9(4):527-535. doi: 10.1001/jamaoncol.2022.7711. | |
| 35511917 |
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Participants in this study included: histologically or cytologically confirmed, Stage IV non-squamous NSCLC; and no prior treatment for Stage IV non-squamous NSCLC.
At the time of study completion a few participants that were still on maintenance treatment with atezolizumab were moved to another study, Post-Trial Access Program, or commercial use. Therefore, the reason for discontinuation was entered "Study terminated by Sponsor" for these participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2018 |
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| Carboplatin | Drug | Carboplatin was administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle. |
|
| Nab-Paclitaxel | Drug | Nab-paclitaxel was administered as IV infusion at a dose of 100 milligrams per square meter (mg/m^2) on Days 1, 8, and 15 of each 21-day cycle. |
|
| Pemetrexed | Drug | Switch maintenance to pemetrexed can be administered within 6 weeks of Day 1 of the last induction cycle. |
|
| Up to approximately 35 months after first subject enrolled |
| OS as Determined by the Investigator Using Recist v1.1 in the ITT Population | OS is defined as the time between the date of randomization and date of death from any cause in the ITT population. | Up to approximately 41 months after first subject enrolled |
| OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT Population | OS is defined as the time between the date of randomization and date of death from any cause in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation. | Up to approximately 35 months after first patient enrolled |
| Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population | ORR (confirmation not required) is defined as the proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by the investigator in the ITT-WT population. | Up to approximately 41 months after first subject enrolled |
| Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population | ORR (confirmation not required) is defined as proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by investigator in ITT population, PD-L1 Expression population, and PD-L1 Expression WT population. ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. PD-L1 expression WT population is defined as PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation. | Up to approximately 35 months after first subject enrolled |
| Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 in ITT-WT Population, ITT Population, and PD-L1 Expression Population and PD-L1 Expression WT Population | DOR,defined for participants with objective response (OR) as time from 1st documented OR to documented disease progression as determined by investigator using RECIST v1.1,or death from any cause,whichever occurs 1st.ITT defined as all randomized participants,regardless of receipt of assigned treatment.ITT-WT defined as ITT population excluding participants with activating EGFR mutation or ALK translocation.PD-L1 expression population is defined as one of following:PD-L1 IHC TC1/2/3 or IC1/2/3 population,defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue;PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue;PD-L1 IHC TC3 or IC3 population,defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue.PD-L1 expression WT is defined as PD-L1 expression population excluding participants with activating EGFR mutation or ALK translocation. | Up to approximately 35 months after first subject enrolled |
| Event Free Rate (%) at Year 1 and 2 in ITT-WT Population and ITT Population | The OS rate at the 1- and 2-year landmark time points after randomization. | Up to 41 months after first patient enrolled, years 1 and 2 reported |
| Event Free Rate (%) at Year 1 and 2 in PD-L1 Expression Population and PD-L1 Expression WT Population | The OS rate at the 1- and 2-year landmark time points after randomization in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation. | Up to 35 months after first patient enrolled, years 1 and 2 reported |
| Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population | Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales. | Up to approximately 35 months after first subject enrolled |
| Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale | Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant. | Up to approximately 35 months after first subject enrolled |
| Percentage of Participants With Adverse Events | Percentage of participants with at least one adverse event. Adverse event onset date before cross over. | Up to approximately 69 months after first patient enrolled |
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab | Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B Carboplatin+nab-paclitaxel Crossover Participants | Up to approximately 35 months after first subject enrolled |
| Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm | Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes. | Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days) |
| Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel | Predose samples will be collected on the same day of treatment administration. | Cycle 1 Day 21, Cycle 2 Day 21, Cycle 3 Day 21, and Cycle 7 Day 21 (Cycle length = 21 days) |
| Plasma Concentrations of Carboplatin | Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 hour after carboplatin infusion (infusion duration=15 to 30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months) |
| Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel | Predose (same day of treatment administration), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after nab-paclitaxel infusion (infusion duration=30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months) |
| Oakland |
| California |
| 94611 |
| United States |
| Kaiser Permanente Medical Center - Roseville | Roseville | California | 95661 | United States |
| Kaiser Permanente - Sacramento Medical Center and Medical Offices | Sacramento | California | 95825 | United States |
| Kaiser Permanente - San Francisco Medical Center | San Francisco | California | 94118 | United States |
| Kaiser Permanente - San Jose Medical Center | San Jose | California | 95119 | United States |
| Kaiser Permanente - San Leandro Medical Center | San Leandro | California | 94577 | United States |
| Kaiser Permanente - Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Permanente - South San Francisco | South San Francisco | California | 94080 | United States |
| Kaiser Permanente; Oncology Clinical Trials | Vallejo | California | 94589 | United States |
| Kaiser Permanente - Walnut Creek | Walnut Creek | California | 94596 | United States |
| Banner MD Anderson Cancer Center | Greeley | Colorado | 85234 | United States |
| Eastern Connecticut Hematology and Oncology Associates; (ECHO) | Norwich | Connecticut | 06360 | United States |
| University of Miami School of Medicine - Sylvester at Deerfield | Deerfield Beach | Florida | Suite 200 | United States |
| SCRI Florida Cancer Specialists South | Fort Myers | Florida | 33916 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) | St. Petersburg | Florida | 33705 | United States |
| SCRI Florida Cancer Specialists East | West Palm Beach | Florida | 33401 | United States |
| University Cancer & Blood Center, LLC; Research | Athens | Georgia | 30607 | United States |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Carrollton | Georgia | 30117 | United States |
| Suburban Hematology / Oncology Associates | Lawrenceville | Georgia | 30046 | United States |
| Southeastern Regional Medical Center, Inc. | Newnan | Georgia | 30265 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Joliet Oncology-Hematology; Associates, Ltd. | Joliet | Illinois | 60435 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Southern Illinois University, Simmons Cancer Institute | Springfield | Illinois | 62794 | United States |
| Fort Wayne Med Oncology & Hematology Inc | Fort Wayne | Indiana | 46845 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242-1083 | United States |
| Lahey Clinic Med Ctr | Lexington | Kentucky | 02421 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20814 | United States |
| Center For Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Southcoast Health System | Fairhaven | Massachusetts | 02719 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Hematology and Oncology Associates at Bridgepoint | Tupelo | Mississippi | 38801 | United States |
| Southeast Nebraska Cancer Ctr | Lincoln | Nebraska | 68510 | United States |
| Va Sierra Nevada Health Care System | Reno | Nevada | 89502 | United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Cancer Inst. of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Laura and ISAAC Perlmutter Cancer Center at NYU Langone. | New York | New York | 10016 | United States |
| Clinical Research Alliance | Westbury | New York | 11590 | United States |
| Presbyterian Hospital | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center; Department of Medicine | Durham | North Carolina | 27710 | United States |
| W.G. Bill Hefner VA Medical Center | Salisbury | North Carolina | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Mark H. Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Oncology Hematology Care, Inc. | Hamilton | Ohio | 45103 | United States |
| Pinnacle Health | Harrisburg | Pennsylvania | 17110 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17604 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Greenville Health System; Cancer Center | Greenville | South Carolina | 29605-4292 | United States |
| University Oncology Associates | Chattanooga | Tennessee | 37403 | United States |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| SCRI The Center For Cancer and Blood Disorders | Denton | Texas | 76210 | United States |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Cancer Care Network of South Texas - SAT & BC | San Antonio | Texas | 78217 | United States |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| CHU Ambroise Paré | Mons | 7000 | Belgium |
| Werken Glorieux VZW | Ronse | 9600 | Belgium |
| GasthuisZusters Antwerpen | Wilrijk | 2610 | Belgium |
| BC Cancer - Surrey | Surrey | British Columbia | V3V 1Z2 | Canada |
| Royal Victoria Regional Health Centre | Barrie | Ontario | L4M 6M2 | Canada |
| William Osler Health Centre | Etobicoke | Ontario | M9V 1R8 | Canada |
| Cite de La Sante de Laval; Hemato-Oncologie | Laval | Quebec | H7M 3L9 | Canada |
| Hôpital Maisonneuve - Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Polyclinique Bordeaux Nord Aquitaine | Bordeaux | 33300 | France |
| Institut Hospitalier Franco-Britannique; Cancerologie | Levallois-Perret | 92300 | France |
| Fondation Hopital Saint Joseph;Cardiologie Clinique | Marseille | 13285 | France |
| Clinique Clementville; Hopital De Jour | Montpellier | 34070 | France |
| Centre D'oncologie de Gentilly; Service Oncologie Medicale | Nancy | 54100 | France |
| Clinique Catherine de Sienne | Nantes | 44202 | France |
| Hopital American de Paris (American Hospital of Paris) | Neuilly-sur-Seine | 92200 | France |
| HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune | Orléans | 45100 | France |
| Hopital Pontchaillou | Rennes | 35033 | France |
| Hopital d'Instruction des Armees de Begin | Saint-Mandé | 94160 | France |
| Centre Hospitalier Regional Sud Reunion; Service de Pneumologie | Saint-Pierre | 97448 | France |
| CHRU Nancy; Pneumologie | Vandœuvre-lès-Nancy | 54511 | France |
| Charite - Universitätsmedizin Berlin; Klinik fur Infektiologie und Pneumologie | Berlin | 13353 | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany |
| Bezirksklinikum Obermain | Ebensfeld | 96250 | Germany |
| Helios Klinikum Erfurt | Erfurt | 99089 | Germany |
| St. Antonius Hospital | Eschweiler | 52249 | Germany |
| Klinikum Esslingen GmbH; Frauenklinik | Esslingen am Neckar | 73730 | Germany |
| Malteser Krankenhaus St. Franziskus-Hospital | Flensburg | 24939 | Germany |
| Krankenhaus Nordwest | Frankfurt am Main | 60488 | Germany |
| Asklepios Fachkliniken GmbH | Gauting | 82131 | Germany |
| SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie | Gera | 07548 | Germany |
| Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie | Gerlingen | 70839 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Thoraxklinik Heidelberg gGmbH | Heidelberg | 69126 | Germany |
| Fachklinik für Lungenerkrankungen | Immenhausen | 34376 | Germany |
| St. Vincentius Kliniken Karlsruhe | Karlsruhe | 76137 | Germany |
| Klinikum Kassel; Hautklinik | Kassel | 34125 | Germany |
| Katholisches Klinikum Marienhof | Koblenz Am Rhein | 56073 | Germany |
| Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I | Lübeck | 23538 | Germany |
| Klinikum Mannheim GmbH Universitätsklinikum | Mannheim | 68167 | Germany |
| Johannes Wesling Klinikum Minden | Minden | 32429 | Germany |
| LMU Klinikum der Universitat Munchen | München | 80337 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Praxis fur Haematologie und Internistische Onkologie | Velbert | 42551 | Germany |
| Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie | Villingen-Schwenningen | 78052 | Germany |
| Helios Klinik Wuppertal | Wuppertal | 42283 | Germany |
| Assaf Harofeh Medical Center | Beer Yaakov | 70300 | Israel |
| Soroka University Medical Centre | Beersheba | 8410101 | Israel |
| Hadassah Ein Karem Hospital; Oncology Dept | Jerusalem | 9112000 | Israel |
| Meir Medical Center; Oncology | Kfar Saba | 4428164 | Israel |
| Galilee Medical Center | Nahariya | 22100 | Israel |
| Rabin Medical Center | Petach Tiqwa | 49100 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Rambam Health Corporation; Oncology Institute | Rambam | 3525408 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Tel Aviv Sourasky Medical Ctr; Oncology | Tel Aviv | 6423906 | Israel |
| Ospedale Clinicizzato SS Annunziata | Chieti | Abruzzo | 66100 | Italy |
| Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati | Avellino | Campania | 83100 | Italy |
| Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica | Naples | Campania | 80131 | Italy |
| Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale | Naples | Campania | 80131 | Italy |
| Ospedale Di Macerata; Oncologia | Province of Macerata | The Marches | 62100 | Italy |
| Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera | Perugia | Umbria | 06129 | Italy |
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Consorcio Hospitalario Provincial de Castellon | Castellon de LA Plana/castello de LA Plana | Castellon | 12002 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | LA Coruña | 15006 | Spain |
| Hospital Universitario de Torrejon | Torrejón de Ardoz | Madrid | 28850 | Spain |
| Hospital Universitario de Canarias | S. Cristobal de La Laguna | Tenerife | 38320 | Spain |
| Hospital Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital de San Pedro de Alcantara | Cáceres | 10003 | Spain |
| Hospital Universitario Virgen de Las Nieves | Granada | 18012 | Spain |
| Hospital General Universitario de Guadalajara | Guadalajara | 19002 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital NisA 9 de Octubre | Valencia | 46015 | Spain |
| Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | 50009 | Spain |
| Derived |
| Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471. |
| 31122901 | Derived | West H, McCleod M, Hussein M, Morabito A, Rittmeyer A, Conter HJ, Kopp HG, Daniel D, McCune S, Mekhail T, Zer A, Reinmuth N, Sadiq A, Sandler A, Lin W, Ochi Lohmann T, Archer V, Wang L, Kowanetz M, Cappuzzo F. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):924-937. doi: 10.1016/S1470-2045(19)30167-6. Epub 2019 May 20. |
| FG001 | Arm B (Nab-Paclitaxel+Carboplatin) | Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit. |
| BG001 | Arm B (Nab-Paclitaxel+Carboplatin) | Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the ITT-WT Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first in the ITT-WT population. | The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 35 months after first patient enrolled |
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| Primary | Overall Survival (OS) in the ITT-WT Population | OS is defined as the time between the date of randomization and date of death from any cause in the ITT-WT population. | The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 35 months after first patient enrolled |
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| Secondary | PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation. | ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population | Posted | Median | 95% Confidence Interval | Months | Up to approximately 35 months after first subject enrolled |
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| Secondary | OS as Determined by the Investigator Using Recist v1.1 in the ITT Population | OS is defined as the time between the date of randomization and date of death from any cause in the ITT population. | The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 41 months after first subject enrolled |
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| Secondary | OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT Population | OS is defined as the time between the date of randomization and date of death from any cause in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation. | PD-L1 Expression Population and PD-L1 Expression WT Population | Posted | Median | 95% Confidence Interval | Months | Up to approximately 35 months after first patient enrolled |
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| Secondary | Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population | ORR (confirmation not required) is defined as the proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by the investigator in the ITT-WT population. | The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation | Posted | Number | Percentage of participants | Up to approximately 41 months after first subject enrolled |
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| Secondary | Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population | ORR (confirmation not required) is defined as proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by investigator in ITT population, PD-L1 Expression population, and PD-L1 Expression WT population. ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. PD-L1 expression WT population is defined as PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation. | ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population | Posted | Number | Percentage of participants | Up to approximately 35 months after first subject enrolled |
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| Secondary | Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 in ITT-WT Population, ITT Population, and PD-L1 Expression Population and PD-L1 Expression WT Population | DOR,defined for participants with objective response (OR) as time from 1st documented OR to documented disease progression as determined by investigator using RECIST v1.1,or death from any cause,whichever occurs 1st.ITT defined as all randomized participants,regardless of receipt of assigned treatment.ITT-WT defined as ITT population excluding participants with activating EGFR mutation or ALK translocation.PD-L1 expression population is defined as one of following:PD-L1 IHC TC1/2/3 or IC1/2/3 population,defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue;PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue;PD-L1 IHC TC3 or IC3 population,defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue.PD-L1 expression WT is defined as PD-L1 expression population excluding participants with activating EGFR mutation or ALK translocation. | ITT-WT Population, ITT Population, and PD-L1 Expression Population and PD-l1 Expression WT Population | Posted | Median | 95% Confidence Interval | Months | Up to approximately 35 months after first subject enrolled |
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| Secondary | Event Free Rate (%) at Year 1 and 2 in ITT-WT Population and ITT Population | The OS rate at the 1- and 2-year landmark time points after randomization. | The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 41 months after first patient enrolled, years 1 and 2 reported |
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| Secondary | Event Free Rate (%) at Year 1 and 2 in PD-L1 Expression Population and PD-L1 Expression WT Population | The OS rate at the 1- and 2-year landmark time points after randomization in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation. | PD-L1 Expression Population and PD-L1 Expression WT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 35 months after first patient enrolled, years 1 and 2 reported |
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| Secondary | Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population | Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales. | The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 35 months after first subject enrolled |
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| Secondary | Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale | Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant. | Patient-reported outcome (PRO) analysis were conducted on either the ITT-WT population or the PRO-evaluable WT population, defined as participants randomized into the ITT-WT population who completed a given PRO questionnaire at the baseline visit and at least one post-baseline visit. | Posted | Mean | Standard Deviation | Units on a scale | Up to approximately 35 months after first subject enrolled |
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| Secondary | Percentage of Participants With Adverse Events | Percentage of participants with at least one adverse event. Adverse event onset date before cross over. | The safety-evaluable population included all treated participants, defined as randomized participants who received any protocol treatment. For the safety analyses, participants were grouped according to whether any full or partial dose of atezolizumab was received, including when atezolizumab was received in error. Specifically, for participants randomized to the CnP arm, if atezolizumab was received in error, the participants were grouped to the Atezo+CnP arm for the safety analyses. | Posted | Number | Percentage of participants | Up to approximately 69 months after first patient enrolled |
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| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab | Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B Carboplatin+nab-paclitaxel Crossover Participants | The baseline ADA-evaluable population included participants who had a baseline ADA result. The post-baseline ADA-evaluable population included participants who had at least one post-baseline ADA result and who had received at least one dose of study treatment. The ADA-evaluable WT population was defined as the ADA-evaluable population excluding participants with an activating EGFR mutation or ALK translocation. | Posted | Number | Perecentage of participants | Up to approximately 35 months after first subject enrolled |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm | Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes. | The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples. | Posted | Mean | Standard Deviation | mcg/mL | Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days) |
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| Secondary | Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel | Predose samples will be collected on the same day of treatment administration. | The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples. | Posted | Mean | Standard Deviation | mcg/mL | Cycle 1 Day 21, Cycle 2 Day 21, Cycle 3 Day 21, and Cycle 7 Day 21 (Cycle length = 21 days) |
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| Secondary | Plasma Concentrations of Carboplatin | The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples. | Posted | Mean | Standard Deviation | ng/mL | Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 hour after carboplatin infusion (infusion duration=15 to 30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months) |
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| Secondary | Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel | The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples. | Posted | Mean | Standard Deviation | ng/mL | Predose (same day of treatment administration), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after nab-paclitaxel infusion (infusion duration=30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months) |
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From the first study drug to the data cutoff date: 18 January 2021 (approximately 69 months)
The safety-evaluable population included all treated participants, defined as randomized participants who received any protocol treatment. For the safety analyses, participants were grouped according to whether any full or partial dose of atezolizumab was received, including when atezolizumab was received in error. Specifically, for participants randomized to the CnP arm, if atezolizumab was received in error, the participants were grouped to the Atezo+CnP arm for the safety analyses.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit. | 338 | 473 | 252 | 473 | 467 | 473 |
| EG001 | Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin) | Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression. This Arm B group includes participants who did not crossover to receive atezolizumab as monotherapy. | 108 | 131 | 63 | 131 | 127 | 131 |
| EG002 | Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy) | Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression. This Arm B group includes participants who crossed over to receive atezolizumab as monotherapy. | 70 | 101 | 24 | 101 | 100 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGRANULOCYTOSIS | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
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| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
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| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
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| HAEMOLYTIC URAEMIC SYNDROME | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
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| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
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| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| ANGINA UNSTABLE | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| BRADYCARDIA | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| CARDIAC ANEURYSM | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| CARDIAC FAILURE CHRONIC | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| CARDIAC TAMPONADE | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| PALPITATIONS | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA version 23.1 | Systematic Assessment |
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| ADDISON'S DISEASE | Endocrine disorders | MedDRA version 23.1 | Systematic Assessment |
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| GLUCOCORTICOID DEFICIENCY | Endocrine disorders | MedDRA version 23.1 | Systematic Assessment |
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| HYPOTHYROIDISM | Endocrine disorders | MedDRA version 23.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| COLITIS | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| DUODENAL ULCER | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| GASTROINTESTINAL VASCULAR MALFORMATION HAEMORRHAGIC | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| ILEUS PARALYTIC | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| IMMUNE-MEDIATED ENTEROCOLITIS | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| LARGE INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| MELAENA | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| OESOPHAGEAL FOOD IMPACTION | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| DEATH | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| DRUG INTERACTION | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| GENERALISED OEDEMA | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| MUCOSAL INFLAMMATION | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| PAIN | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| PERFORMANCE STATUS DECREASED | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| SUDDEN DEATH | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | General disorders | MedDRA version 23.1 | Systematic Assessment |
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| AUTOIMMUNE HEPATITIS | Hepatobiliary disorders | MedDRA version 23.1 | Systematic Assessment |
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| BILE DUCT STONE | Hepatobiliary disorders | MedDRA version 23.1 | Systematic Assessment |
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| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA version 23.1 | Systematic Assessment |
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| CHOLESTASIS | Hepatobiliary disorders | MedDRA version 23.1 | Systematic Assessment |
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| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA version 23.1 | Systematic Assessment |
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| HEPATITIS | Hepatobiliary disorders | MedDRA version 23.1 | Systematic Assessment |
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| HEPATOCELLULAR INJURY | Hepatobiliary disorders | MedDRA version 23.1 | Systematic Assessment |
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| IMMUNE-MEDIATED HEPATITIS | Hepatobiliary disorders | MedDRA version 23.1 | Systematic Assessment |
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| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA version 23.1 | Systematic Assessment |
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| APPENDICITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| APPENDICITIS PERFORATED | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| ATYPICAL PNEUMONIA | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| BACTERAEMIA | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| BACTERIAL COLITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| BACTERIAL SEPSIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| CAMPYLOBACTER INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| CONJUNCTIVITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| CYSTITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| CYTOMEGALOVIRUS COLITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| DEVICE RELATED INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| ENCEPHALITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| FEBRILE INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| FURUNCLE | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| GANGRENE | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| INFECTIOUS PLEURAL EFFUSION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| NEUTROPENIC INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| PARAPHARYNGEAL SPACE INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| PULMONARY SEPSIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| TRACHEOBRONCHITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Systematic Assessment |
| |
| SARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| TOXIC NEUROPATHY | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| VASOGENIC CEREBRAL OEDEMA | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DISORIENTATION | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| AUTOIMMUNE NEPHRITIS | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| NEPHRITIS | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| NEPHROPATHY TOXIC | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| POSTRENAL FAILURE | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| TUBULOINTERSTITIAL NEPHRITIS | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ORGANISING PNEUMONIA | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| OROPHARYNGEAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PNEUMOTHORAX SPONTANEOUS | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PULMONARY HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ABORTION INDUCED | Surgical and medical procedures | MedDRA version 23.1 | Systematic Assessment |
| |
| ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| FEMORAL ARTERY ANEURYSM | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| JUGULAR VEIN THROMBOSIS | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| VASCULAR STENOSIS | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | 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 |
| Mar 13, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D016190 | Carboplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| OG001 | Arm B (Nab-Paclitaxel+Carboplatin) | Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression. |
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| Arm B (Nab-Paclitaxel+Carboplatin) |
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression. |
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| OG001 | Arm B (Nab-Paclitaxel+Carboplatin) | Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression. |
|
|
|
| OG001 | Arm B (Nab-Paclitaxel+Carboplatin) | Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression. |
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Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression. |
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| OG001 | Arm B (Nab-Paclitaxel+Carboplatin) | Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression. |
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