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]
Completed · Phase 3
Conditions studied: Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT02409342
- Run by
- Hoffmann-La Roche
- People needed
- 572
- Starts
- 2015-07-20
- Expected to finish
- 2022-03-08
- Last updated by the study team
- 2023-03-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Yale Cancer Center — New Haven, Connecticut, United States
- Lynn Cancer Institute - West — Boca Raton, Florida, United States
- University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
- Oregon Health & Science Uni — Portland, Oregon, United States
- Sarah Cannon Cancer Center — Germantown, Tennessee, United States
- Vanderbilt University Medical Center; Multiple Sclerosis Center — Nashville, Tennessee, United States
- Hematology Oncology Associates of Fredericksburg, Inc. — Fredericksburg, Virginia, United States
- VA Puget Sound Health Care Sys — Seattle, Washington, United States
- Centro de Pesquisas Clinicas em Oncologia - CPCO — Cachoeiro de Itapemirim, Espírito Santo, Brazil
- Oncovida*X — Salvador, Estado de Bahia, Brazil
- Instituto Nacional de Cancer - INCa; Oncologia — Rio de Janeiro, Rio de Janeiro, Brazil
- Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia — Ijuí, Rio Grande do Sul, Brazil
- Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia — Passo Fundo, Rio Grande do Sul, Brazil
- Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
- Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
- Instituto Joinvilense de Hematologia E Oncologia — Joinville, Santa Catarina, Brazil
- *X*Fundacao PIO XII — Barretos, São Paulo, Brazil
- Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira — São Paulo, São Paulo, Brazil
- Hospital Santa Marcelina — São Paulo, São Paulo, Brazil
- Harbin Medical University Tumor Hospital — Harbin, China
- CHU Angers — Angers, France
- Hospital d Instructions des Armees Percy — Clamart, France
- Hôpital Universitaire Dupuytren — Limoges, France
- Clinique Clémentville — Montpellier, France
- University of California San Diego — La Jolla, California, United States
Full record on ClinicalTrials.gov
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