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A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]
- Non-Small Cell Lung Cancer
Trial Status:
Active, not recruiting
This trial runs in
Cities
- Adana
- Aichi
- Alba Iulia
- Angers
- Ankara
- Arkhangelsk
- Athina
- Aviano
- Badalona
- Baltimore
- Barakaldo
- Barcelona
- Barretos
- Beijing City
- Belfast
- Beograd
- Bergamo
- Bilbao
- Birmingham
- Boca Raton
- Brasov
- Brasília
- Bristol
- Budapest
- Cachoeiro de Itapemirim
- Castelló de la Plana
- Catania
- Chengdu
- Clamart
- Cluj-Napoca
- Colchester, Essex
- Coruña
- Craiova
- Cremona
- Córdoba
- Dalian
- Dnipropetrovsk
- Duarte
- Easton
- Fredericksburg
- Fukuoka
- Gauting
- Gdansk
- Genova
- Germantown
- Grimsby
- Guadalajara
- Guangzhou
- Gyeonggi-do
- Harbin City
- Harvey
- Hat Yai
- Hefei Shi
- Hershey
- Hokkaido
- Honolulu
- Hyogo
- Iasi
- Ibaraki
- Ijui
- Istanbul
- Ivano-Frankivs'k
- Ivanovo
- Izmir
- Jaén
- Jeollanam-do
- Jiangsu Sheng
- Jinan City
- Joinville
- Kazan
- Kharkiv
- Khon Kaen
- Kirovograd
- Kragujevac
- Kursk
- Kyiv
- La Jolla
- Larissa
- Limoges
- London
- Lutsk
- Lviv
- Madrid
- Malatya
- Manchester
- Meldola
- Miami Beach
- Milano
- Minas Gerais
- Miyagi
- Montpellier
- Monza
- Morgantown
- Moscovskaya Oblast
- Moscow
- Muang
- Nancy
- Nashville
- New Haven
- New York
- Nizhny Novgorod
- Novara
- Nyíregyháza
- Obninsk
- Odesa
- Okayama
- Oldenburg
- Olsztyn
- Osaka
- Otwock
- Padova
- Palma De Mallorca
- Paris
- Passo Fundo
- Patras
- Pessac
- Phitsanulok
- Portland
- Porto Alegre
- Poznan
- Pécs
- Rimini
- Rio de Janeiro
- Roma
- Rozzano (MI)
- Ryazan
- S. Cristobal De La Laguna
- Saint Denis Cedex
- Saint Pierre
- Saint-Mandé
- Saint-Petersburg
- Saitama
- Sakai-shi
- Salvador
- Santander
- Saransk
- Seattle
- Seoul
- Sepulveda
- Sevilla
- Shanghai
- Sibiu
- Sremska Kamenica
- St Brieuc
- St Petersburg
- St. Petersburg
- Strasbourg
- Sumy
- Suwon-si,
- Syracuse
- Szolnok
- São Paulo
- Thermi, Thessaloniki
- Thessaloniki
- Timisoara
- Timișoara
- Tokyo
- Torino
- Uzhgorod
- València
- Verona
- Vinnytsia
- Volgograd
- Washington
- Wuhan City
- Zaragoza
- Zhengzhou Shi
Trial Identifier:
NCT02409342 2014-003083-21 GO29431
Trial Summary
This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02409342 , GO29431 , 2014-003083-21
Trial Identifier
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Carboplatin, Cisplatin, Gemcitabine, Pemetrexed
Treatments
Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer
Condition
Official Title
A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
All
Gender
≥ 18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
- No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study
- Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Adequate hematologic and end-organ function
Exclusion Criteria
- Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
- Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation
- 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 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 (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, 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