A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
- Cancer
- Lung Cancer
- Non-Small Cell Lung Cancer (NSCLC)
Completed
- 's-Hertogenbosch
- ABD
- Adelaide
- Amsterdam
- Ann Arbor
- Arequipa
- Atlanta
- Auburn
- Augsburg
- Baltimore
- Barcelona
- Bellflower
- Bend
- Berkeley Heights
- Berlin
- Bethesda
- Bethlehem
- Bettendorf
- Bielefeld
- Billings
- Binningen
- Bochum
- Bordeaux
- Bratislavský kraj
- Breda
- Buenos Aires
- Camperdown
- Catania
- Chandler
- Chermside
- Chernivtsi
- Chicago
- Cincinnati
- Coimbra
- Columbia
- Concord
- Córdoba
- Danbury
- Denver
- Dnipropetrovs'k
- Douglas
- Dresden
- Duluth
- Ede
- Everett
- Fairfax
- Flagstaff
- Fort Lauderdale
- Frankfurt am Main
- Frankston
- Fukuoka
- Genova
- Germantown
- Großhansdorf
- Halle (Saale)
- Hamburg
- Harvey
- Heidelberg
- Hemer
- Henderson
- Hilversum
- Hobart
- Homburg
- Hoofddorp
- Houston
- Jacksonville
- Kansas City
- Kaohsiung City
- Kharkiv
- Kingswood
- Knoxville
- Kryvyi Rih
- Kurralta Park
- Kurume
- Kyiv
- Köln
- L'Hospitalet de Llobregat
- La Rioja
- La Tronche
- larkspur
- Las Palmas de Gran Canaria
- Launceston
- Le Mans
- Lido di Camaiore
- Lisboa
- Livorno
- Londrina
- Lone Tree
- Longview
- Louisville
- Lugo
- luik
- Löwenstein
- Maastricht
- Madrid
- Malvern
- Marseille
- Matsuyama
- Melbourne
- Miami Beach
- Minas Gerais
- Minato City
- Missoula
- Mitaka
- Monterrey
- Morgantown
- Moscow
- München
- Namur
- Napoli
- Natori
- Nedlands
- New Haven
- New York
- Nieuwegein
- Niigata
- Norfolk
- Novara
- Omsk Oblast
- Orange
- Osaka
- Oshawa
- Ourense
- Palma
- Paramus
- Paris
- Park Ridge
- Pessac
- Pinehurst
- Pittsburgh
- Plovdiv
- Podkarpackie Voivodeship
- Poltava
- Port St. Lucie
- Porto
- Prešovský kraj
- Providencia
- Regensburg
- Rheine
- Richmond
- Rio Grande do Norte
- Rio Grande do Sul
- Roanoke
- Roma
- Rotterdam
- Rīga
- Sabadell
- Sagamihara
- Saint Petersburg
- Saint-Denis
- Saint-Quentin
- Salzburg
- San Antonio
- San Diego
- Sankt-Peterburg
- Santa Fe
- Santa Rosa
- Santander
- Santiago
- Santiago de Querétaro
- Sassari
- Scarborough
- Seattle
- Shinjuku City
- Singapore
- Sofia
- Spokane
- Springfield
- St Albans
- St. Gallen
- St. Louis
- St. Louis Park
- stepanovskoye
- Sumy
- Surquillo
- sursee
- São Paulo
- Taichung City
- Tainan City
- Taipei City
- Taoyuan City
- Temuco
- Toledo
- Toluca de Lerdo
- Toulon
- Toulouse
- Toyonaka
- Utrecht
- Uzhhorod
- València
- Viedma
- Vilnius
- Vinnytsia
- Wakayama
- washington-township
- Wels
- Woolloongabba
- Xàtiva
- Yokohama
- Zaporizhzhia
- Zutphen
- 横浜市
NCT02366143 2014-003207-30 GO29436
Trial Summary
This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).
A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
- Eastern Cooperative Oncology Group performance status 0 or 1
- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
- Participants with no prior treatment for Stage IV non-squamous NSCLC
- Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end organ function
Cancer-Specific Exclusions:
- Active or untreated central nervous system metastases
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
General Medical Exclusions:
- Pregnant or lactating women
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Positive test for human immunodeficiency virus
- Active hepatitis B or hepatitis C
- Severe infection within 4 weeks prior to randomization
- Significant cardiovascular disease
- Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures
Exclusion Criteria Related to Medications:
- Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
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