Lung Cancer Clinical Trial
Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
Summary
This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria for Enrollment Phase
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histological or cytological diagnosis of Stage IB (tumors greater than or equal to [>/=] 4 centimeters [cm])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009)
Participants must have had complete resection of NSCLC 4-12 weeks (>/=28 days and less than or equal to [=] 84 days) prior to enrollment and must be adequately recovered from surgery
If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography [CT] and positron emission tomography [PET] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeon's decision
Eligible to receive a cisplatin-based chemotherapy regimen
Adequate hematologic and end-organ function
Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy
Inclusion Criteria for Randomized Phase - Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of atezolizumab or BSC
Exclusion Criteria:
Exclusion Criteria for Enrollment Phase
Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures
Pregnant and lactating women
Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor
Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment
Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment
Participants with hearing impairment
Known sensitivity to any component of the chemotherapy regimen the participant will be assigned to, or to mannitol
Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed death ligand 1 (PD-L1) therapeutic antibodies
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS greater than [>] 90 percent [%]) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
Positive test for human immunodeficiency virus (HIV)
Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
Active tuberculosis
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within the previous 3 months, unstable arrhythmias, or unstable angina
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Prior allogeneic bone marrow transplantation or solid organ transplant
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC) assay from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded)
Specific Exclusions for Pemetrexed Treatment
- Participants with squamous cell histology
Exclusion Criteria for Randomized Phase
Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to randomization
Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study
Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization: Prior treatment with cancer vaccines is allowed
Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization
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There are 224 Locations for this study
Springdale Arkansas, 72762, United States
Bellflower California, 90706, United States
Corona California, 92882, United States
Palo Alto California, 94305, United States
San Marcos California, 92069, United States
Santa Monica California, 90404, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Danbury Connecticut, 06810, United States
Norwich Connecticut, 06360, United States
Boca Raton Florida, 33428, United States
Deerfield Beach Florida, Suite, United States
Fort Lauderdale Florida, 33308, United States
Fort Myers Florida, 33908, United States
Saint Petersburg Florida, 33705, United States
West Palm Beach Florida, 33401, United States
Athens Georgia, 30607, United States
Carrollton Georgia, 30117, United States
Thomasville Georgia, 31792, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Harvey Illinois, 60426, United States
Peoria Illinois, 61615, United States
Quincy Illinois, 62301, United States
Springfield Illinois, 62794, United States
Louisville Kentucky, 40202, United States
Scarborough Maine, 04074, United States
Detroit Michigan, 48201, United States
Grand Rapids Michigan, 49503, United States
Tupelo Mississippi, 38801, United States
Kansas City Missouri, 64111, United States
Henderson Nevada, 89014, United States
Florham Park New Jersey, 07932, United States
Livingston New Jersey, 07039, United States
Paramus New Jersey, 07652, United States
Summit New Jersey, 07901, United States
New York New York, 10065, United States
Westbury New York, 11590, United States
Charlotte North Carolina, 28204, United States
Cincinnati Ohio, 45203, United States
Cincinnati Ohio, 45242, United States
Columbus Ohio, 43219, United States
Portland Oregon, 97239, United States
Bethlehem Pennsylvania, 18015, United States
Harrisburg Pennsylvania, 17110, United States
Pittsburgh Pennsylvania, 15212, United States
Providence Rhode Island, 02903, United States
Greenville South Carolina, 29605, United States
Chattanooga Tennessee, 37403, United States
Chattanooga Tennessee, 37404, United States
Germantown Tennessee, 38138, United States
Houston Texas, 77030, United States
Bristol Virginia, 24201, United States
Fredericksburg Virginia, 22408, United States
Auburn Washington, 98002, United States
Everett Washington, 98201, United States
Seattle Washington, 98104, United States
Townsville Queensland, 4810, Australia
Malvern Victoria, 3144, Australia
Bruxelles , 1200, Belgium
Liège , 4000, Belgium
Etobicoke Ontario, M9V 1, Canada
Laval Quebec, H7M 3, Canada
Beijing , 10002, China
Beijing , 10014, China
Beijing , 10085, China
Guangdong , 52402, China
Guangzhou , 51012, China
Hefei City , 23003, China
Shanghai , 20000, China
Shanghai , 20043, China
Shengyang , 11004, China
Shenyang , 11000, China
Suzhou , 21500, China
Zhejiang , 31002, China
Limoges , 87042, France
Lyon , 69008, France
Marseille , 13285, France
Mont De Marsan , 40024, France
Montpellier , 34070, France
Montpellier , 34298, France
Nantes , 44805, France
Saint Pierre , 97448, France
Saint-Mande , 94160, France
Saint-Quentin , 02321, France
Toulon , 83000, France
Toulon , 83041, France
Berlin , 13125, Germany
Bielefeld , 33611, Germany
Braunschweig , 38114, Germany
Chemnitz , 09116, Germany
Frankfurt am Main , 60488, Germany
Großhansdorf , 22927, Germany
Halle , 06120, Germany
Hamburg , 20246, Germany
Hamburg , 21075, Germany
Heidelberg , 69126, Germany
Hemer , 58675, Germany
Homburg , 66421, Germany
Immenhausen , 34376, Germany
Karlsruhe , 76137, Germany
Koblenz Am Rhein , 56073, Germany
Koln , 51109, Germany
Löwenstein , 74245, Germany
München , 81925, Germany
Münster , 48153, Germany
Oldenburg , 26121, Germany
Regensburg , 93049, Germany
Velbert , 42551, Germany
Shatin , , Hong Kong
Budapest , 1088, Hungary
Pecs , 7624, Hungary
Szolnok , 5000, Hungary
Torokbalint , 2045, Hungary
Haifa , 31096, Israel
Holon , 58220, Israel
Kfar-Saba , 44281, Israel
Petach Tikva , 49222, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Chieti Abruzzo, 66100, Italy
Pordenone Friuli-Venezia Giulia, 33170, Italy
Roma Lazio, 00128, Italy
Bergamo Lombardia, 24127, Italy
Brescia Lombardia, 25123, Italy
Milano Lombardia, 20132, Italy
Cuneo Piemonte, 12100, Italy
Novara Piemonte, 28100, Italy
Orbassano Piemonte, 10043, Italy
Torino Piemonte, 10126, Italy
Palermo Sicilia, 90127, Italy
Pisa Toscana, 56126, Italy
Trento Trentino-Alto Adige, 38100, Italy
Perugia Umbria, 06122, Italy
Verona Veneto, 37126, Italy
Aichi , 464-8, Japan
Aichi , 466-8, Japan
Chiba , 277-8, Japan
Ehime , 791-0, Japan
Fukuoka , 812-8, Japan
Hiroshima , 734-8, Japan
Hokkaido , 003-0, Japan
Hyogo , 673-0, Japan
Kanagawa , 241-8, Japan
Kitakyushu-shi , 807-8, Japan
Kumamoto , 860-8, Japan
Kyoto , 606-8, Japan
Miyagi , 980-0, Japan
Niigata , 951-8, Japan
Okayama , 700-8, Japan
Saitama , 362-0, Japan
Shizuoka , 411-8, Japan
Tokyo , 104-0, Japan
Tokyo , 105-8, Japan
Tokyo , 113-8, Japan
Tokyo , 113-8, Japan
Tokyo , 160-0, Japan
Tokyo , 181-8, Japan
Wakayama , 641-8, Japan
Jeollanam-do , 58128, Korea, Republic of
Suwon-si , 16247, Korea, Republic of
'S Hertogenbosch , 5223 , Netherlands
Groningen , 9728 , Netherlands
Nieuwegein , 3435 , Netherlands
Otwock , 05-40, Poland
Poznan , 60-56, Poland
Coimbra , 3000-, Portugal
Lisboa , 1769-, Portugal
Porto , 4200-, Portugal
Porto , 4200, Portugal
Craiova , 20034, Romania
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Moscow Moskovskaja Oblast, 10522, Russian Federation
Moscow Moskovskaja Oblast, 11547, Russian Federation
St. Petersburg Sankt Petersburg, 19775, Russian Federation
Kazan Tatarstan, 42002, Russian Federation
Novosibirsk , 63004, Russian Federation
Pushkin , 19660, Russian Federation
Saint Petersburg , 19775, Russian Federation
Saint-Petersburg , 19702, Russian Federation
Saransk , 43003, Russian Federation
St Petersburg , 19429, Russian Federation
St Petersburg , 19708, Russian Federation
Volgograd , 40013, Russian Federation
Yaroslavl , 15004, Russian Federation
Badalona Barcelona, 08916, Spain
Santander Cantabria, 39008, Spain
Castellon DE LA Plana/castello DE LA Plana Castellon, 12002, Spain
Palma De Mallorca Islas Baleares, 07014, Spain
A Coruna LA Coruña, 15009, Spain
El Palmar Murcia, 30120, Spain
S. Cristobal De La Laguna Tenerife, 38320, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08041, Spain
Cordoba , 14004, Spain
Jaen , 23007, Spain
Lugo , 27003, Spain
Madrid , 28014, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Valencia , 46010, Spain
Valencia , 46015, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Chang Hua , 500, Taiwan
Kaohsiung City , 807, Taiwan
Liuying Township , 736, Taiwan
Putzu , 613, Taiwan
Taipei City , 10041, Taiwan
Taipei City , 112, Taiwan
Taipei , 104, Taiwan
Taoyuan City , 333, Taiwan
Xitun Dist. , 40705, Taiwan
Dnipropetrovsk Katerynoslav Governorate, 49102, Ukraine
Kharkiv Kharkiv Governorate, 61070, Ukraine
Kyiv KIEV Governorate, 02096, Ukraine
Odesa KIEV Governorate, 65055, Ukraine
Vinnytsia Podolia Governorate, 21029, Ukraine
Ivano-Frankivsk Poltava Governorate, 76018, Ukraine
Kirovograd , 25006, Ukraine
Kryvyi Rih , 50048, Ukraine
Kyiv , 03115, Ukraine
Sumy , 40005, Ukraine
Zaporizhzhya , 69040, Ukraine
Birmingham , B9 5S, United Kingdom
Colchester, Essex , CO4 5, United Kingdom
London , EC1M , United Kingdom
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