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A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]
- Cancer
- Lung Cancer
- Non-Small Cell Lung Cancer (NSCLC)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- A Coruña
- ABD
- Adelaide
- Akashi
- Amsterdam
- Antwerpen
- Arequipa
- Athens
- Avellino
- Barcelona
- Bari
- Barrie
- Be'er Sheva
- Bellflower
- Berlin
- Bethlehem
- Bettendorf
- Billings
- Bochum
- botevgrad
- Bratislavský kraj
- Bruxelles
- Campania
- Camperdown
- Carrollton
- Catania
- Chandler
- Changhua County
- Chattanooga
- Chermside
- Chernivtsi
- chiayi-county
- Chicago
- Chuo City
- Cincinnati
- Columbus
- Córdoba
- Danbury
- Denton
- Denver
- Detroit
- Dnipro
- Douglas
- Dresden
- Ede
- Eindhoven
- Everett
- Fairfax
- Fairhaven
- Fort Lauderdale
- Fort Myers
- Fort Wayne
- Frankfurt am Main
- Fukuoka
- Genoa
- Gerlingen
- Gettysburg
- Großhansdorf
- Habikino
- Halle (Saale)
- Hamburg
- Heidelberg
- Hemer
- Himeji
- Hirakata
- Homburg
- Immenhausen
- Ina
- Jerusalem
- Joliet
- Kaohsiung City
- Kashiwa
- Kefar Sava
- Kharkiv
- Knoxville
- Kobe
- Kryvyi Rih
- Kyoto
- Köln
- L'Hospitalet de Llobregat
- La Laguna
- La Rioja
- La Tronche
- La Victoria
- Las Palmas de Gran Canaria
- Laval
- Le Mans
- Lexington
- Lisbon
- Londrina
- Longview
- Louisville
- Lugo
- luik
- Lviv
- Lyon
- Macon
- Madrid
- Malvern
- Matsuyama
- Minas Gerais
- Minden
- Monterrey
- Montpellier
- Montréal
- Moscow
- Moscow Oblast
- München
- Nagaizumi
- Nagoya
- Namur
- Napoli
- Nedlands
- New Orleans
- Newnan
- Nieuwegein
- Niigata
- Norfolk
- Oakland
- Okayama
- Omsk Oblast
- Osaka
- Oshawa
- oullins-pierre-benite
- Palm Beach Gardens
- Palma
- Paramus
- Pavia
- Pergamino
- Perugia
- Petah Tikva
- Pisa
- Pittsburgh
- Plovdiv
- Poltava
- Port St. Lucie
- Portland
- Porto
- Porto Alegre
- Prešovský kraj
- Quincy
- Ramat Gan
- Regensburg
- Rennes
- Rheine
- Rio Grande do Norte
- Rio Grande do Sul
- Roanoke
- Roma
- Ronse
- Rīga
- Sabadell
- Sacramento
- Saint Albans
- Saint Petersburg
- Saint-Jérôme
- Saint-Quentin
- Sakai
- Salisbury
- Salzburg
- San Leandro
- Santa Clara
- Santa Rosa
- Santander
- Santiago
- Santiago de Querétaro
- Scarborough
- Sendai
- Sevilla
- Shinjuku City
- Singapore
- Sioux City
- Spokane
- Springdale
- St. Petersburg
- Sumy
- São Paulo
- Taichung City
- Tainan City
- Taipei City
- Tel Aviv-Yafo
- Temuco
- Toronto
- Toulon
- Trujillo
- Tupelo
- Tuscany
- Uzhhorod
- Vallejo
- València
- Viedma
- Villingen-Schwenningen
- Vilnius
- Vinnytsia
- volgograd
- Walnut Creek
- Waratah
- washington-township
- westbury
- Woolloongabba
- Yokohama
- Ypsilanti
- Zaporizhzhia
- Zaragoza
- 横浜市
Trial Identifier:
NCT02367794 2014-003208-59 GO29437
Trial Summary
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02367794, GO29437, 2014-003208-59
Trial Identifier
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody, Carboplatin, Nab-Paclitaxel, Paclitaxel
Treatments
Squamous Non-Small Cell Lung Cancer
Condition
Official Title
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
- Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end organ function
Exclusion Criteria
- Active or untreated central nervous system (CNS) metastasis
- 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
- 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 (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Positive test for Human Immunodeficiency Virus (HIV)
- Active hepatitis B or hepatitis C
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
- Severe infection within 4 weeks prior to randomization
- Significant history of cardiovascular disease
For the latest version of this information please go to www.forpatients.roche.com