Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001142-34 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel | Active Comparator | Participants received docetaxel 75 milligram per meter square (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death. |
|
| Atezolizumab | Experimental | Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Participants received starting dose of 75 mg/m^2 every three week (q3w) until disease progression, unacceptable toxicity or death. Dose modifications were according to the locally approved label. Participants randomized to receive docetaxel had to be premedicated with corticosteroids according to local practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive. | From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85704 | United States | ||
| Genesis Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36428744 | Derived | Dong Y, Zhu Y, Zhuo M, Chen X, Xie Y, Duan J, Bai H, Hao S, Yu Z, Yi Y, Guan Y, Yuan J, Xia X, Yi X, Wang J, Wang Z. Maximum Somatic Allele Frequency-Adjusted Blood-Based Tumor Mutational Burden Predicts the Efficacy of Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer. Cancers (Basel). 2022 Nov 17;14(22):5649. doi: 10.3390/cancers14225649. | |
| 33241650 |
Not provided
Not provided
A total of 527 participants were screened, of whom 287 participants were randomized. 143 participants to the docetaxel arm and 144 participants to the atezolizumab arm. Overall, 10 participants (8 in the docetaxel arm and 2 in the atezolizumab arm) did not receive any study treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel | Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death. |
| FG001 | Atezolizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Atezolizumab | Drug | Participants received atezolizumab of 1200 mg (equivalent to an average body weight-based dose of 15 milligram per kilogram [mg/kg]) which was administered by IV infusion q3w on Day 1 of each 21 day cycle. Participants were allowed to continue treatment beyond progression per response evaluation criteria in solid tumors (RECIST) v1.1 if they were experiencing clinical benefit per investigator, did not have a decline in performance status, did not have signs or symptoms of unequivocal progression, did not have tumor progression at critical sites, and signed an informed consent signature page acknowledging deferment any standard treatment options that may exist in favor of continuing atezolizumab. |
|
| Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) |
| Progression-Free Survival (PFS) | PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) |
| Duration of Response (DOR) | DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first. | From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) |
| ORR (Modified RECIST) | ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months) |
| PFS (Modified RECIST) | PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months) |
| DOR (Modified RECIST) | DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first. | From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months) |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Kaiser Permanente - San Marcos | San Marcos | California | 92069 | United States |
| Kaiser Permanente - Vallejo | Vallejo | California | 94589 | United States |
| Innovative Clinical Research Institute | Whittier | California | 90603 | United States |
| Rocky Mountain Cancer Centers - Colorado Springs (Circle) | Lone Tree | Colorado | 80124 | United States |
| Ocala Oncology Center | Ocala | Florida | 34471 | United States |
| Georgia Cancer Specialists | Atlanta | Georgia | 30341 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| New England Cancer Specialists | Scarborough | Maine | 04074 | United States |
| Karmanos Cancer Institute.. | Detroit | Michigan | 48201 | United States |
| Billings Clinic; Research Center | Billings | Montana | 59101 | United States |
| Comprehensive Cancer Centers of Nevada - Eastern Avenue | Las Vegas | Nevada | 89169 | United States |
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| Broome Oncology - Binghamton | Binghamton | New York | 13905 | United States |
| Willamette Valley Cancer Ctr - 520 Country Club | Eugene | Oregon | 97401-8122 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Center for Biomedical Research LLC | Knoxville | Tennessee | 37909 | United States |
| Texas Oncology - South Austin | Austin | Texas | 78745 | United States |
| Texas Oncology, P.A. - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| Northwest Cancer Specialists - Vancouver | Vancouver | Washington | 98684 | United States |
| Providence St. Mary Regional Cancer Center | Walla Walla | Washington | 99362 | United States |
| Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | 98801 | United States |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Chr de La Citadelle | Liège | 4000 | Belgium |
| Cite de La Sante de Laval; Hemato-Oncologie | Laval | Quebec | H7M 3L9 | Canada |
| McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec | H3T 1E2 | Canada |
| Hopital Gabriel Montpied; Service de Pneumologie | Clermont-Ferrand | 63003 | France |
| Hôpital Nord Michallon; Pneumologie | La Tronche | 38700 | France |
| Centre D'Oncologie de Gentilly; Oncology | Nancy | 54100 | France |
| Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie | Saint-Brieuc | 22027 | France |
| Hopital Larrey; Pneumologie | Toulouse | 31059 | France |
| Asklepios-Fachkliniken Muenchen-Gauting; Onkologie | Gauting | 82131 | Germany |
| Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II | Halle | 06120 | Germany |
| Fachklinik für Lungenerkrankungen | Immenhausen | 34376 | Germany |
| Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie | Regensburg | 93053 | Germany |
| Citta Ospedaliera; Divisione Oncologia Medica | Avellino | Campania | 83100 | Italy |
| Irccs Ospedale San Raffaele;Oncologia Medica | Milan | Lombardy | 20132 | Italy |
| Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii | Gdansk | 80-214 | Poland |
| Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii | Lodz | 93-513 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii | Otwock | 05-400 | Poland |
| Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii | Warsaw | 02-781 | Poland |
| National Cancer Center; Medical Oncology | Gyeonggi-do | 410-769 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Centre; Division of Hematology/Oncology | Seoul | 135-710 | South Korea |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | 50009 | Spain |
| Universitetssjukhuset Linköping; Lungmedicinkliniken | Linköping | 581 85 | Sweden |
| Chulalongkorn Hospital; Medical Oncology | Bangkok | 10330 | Thailand |
| Rajavithi Hospital; Division of Medical Oncology | Bangkok | 10400 | Thailand |
| Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | 10700 | Thailand |
| Akdeniz University Medical Faculty; Medical Oncology Department | Antalya | 07070 | Turkey (Türkiye) |
| Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology | Istanbul | 34300 | Turkey (Türkiye) |
| Royal Free Hospital; Dept of Oncology | London | NW3 2QG | United Kingdom |
| Guys and St Thomas NHS Foundation Trust, Guys Hospital | London | SE1 9RT | United Kingdom |
| Charing Cross Hospital; Medical Oncology. | London | W6 8RF | United Kingdom |
| Christie Hospital Nhs Trust; Medical Oncology | Manchester | M2O 4BX | United Kingdom |
| Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685. |
| 32115349 | Derived | Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16. |
| 31511069 | Derived | Fehlings M, Jhunjhunwala S, Kowanetz M, O'Gorman WE, Hegde PS, Sumatoh H, Lee BH, Nardin A, Becht E, Flynn S, Ballinger M, Newell EW, Yadav M. Late-differentiated effector neoantigen-specific CD8+ T cells are enriched in peripheral blood of non-small cell lung carcinoma patients responding to atezolizumab treatment. J Immunother Cancer. 2019 Sep 12;7(1):249. doi: 10.1186/s40425-019-0695-9. |
| 26970723 | Derived | Fehrenbacher L, Spira A, Ballinger M, Kowanetz M, Vansteenkiste J, Mazieres J, Park K, Smith D, Artal-Cortes A, Lewanski C, Braiteh F, Waterkamp D, He P, Zou W, Chen DS, Yi J, Sandler A, Rittmeyer A; POPLAR Study Group. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1837-46. doi: 10.1016/S0140-6736(16)00587-0. Epub 2016 Mar 10. |
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
| Received Treatment | Two patients in the docetaxel arm crossed over to receive atezolizumab treatment. |
|
| COMPLETED | Study terminated by Sponsor participants either discontinued or enrolled in extension study |
|
| NOT COMPLETED |
|
|
Intent to treat (ITT) population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel | Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death. |
| BG001 | Atezolizumab | Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| 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 | Overall Survival (OS) | Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive. | ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. | Posted | Median | 95% Confidence Interval | months | From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. | Posted | Median | 95% Confidence Interval | months | From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first. | ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ORR (Modified RECIST) | ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only | Posted | Number | 95% Confidence Interval | percentage of participants | From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS (Modified RECIST) | PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only | Posted | Median | 95% Confidence Interval | months | From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR (Modified RECIST) | DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first. | ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. The data was planned to be reported for Atezolizumab arm only. | Posted | Median | 95% Confidence Interval | months | From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months) |
|
|
From the first study drug to the data cutoff date: 31 August 2018
Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
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 | Docetaxel | Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death. | 118 | 143 | 46 | 135 | 125 | 135 |
| EG001 | Atezolizumab | Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator. | 121 | 144 | 53 | 142 | 127 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolism | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Venous stenosis | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Ulcer haemorrhage | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Contrast Media Allergy | Immune system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Thoracic Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Device Dislocation | Product Issues | MedDRA (21.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (21.1) | 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 |
| 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 |
|---|---|
| D000077143 | Docetaxel |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|