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]
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.
Checked against the public recordLast updated Mar 15, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Hoffmann-La Roche
- Interventions being studied
- Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of California San DiegoLa Jolla, California
- Yale Cancer CenterNew Haven, Connecticut
- Lynn Cancer Institute - WestBoca Raton, Florida
- University of Maryland Greenebaum Cancer CenterBaltimore, Maryland
- Oregon Health & Science UniPortland, Oregon
- Sarah Cannon Cancer CenterGermantown, Tennessee
- Vanderbilt University Medical Center; Multiple Sclerosis CenterNashville, Tennessee
- Hematology Oncology Associates of Fredericksburg, Inc.Fredericksburg, Virginia
- VA Puget Sound Health Care SysSeattle, Washington
- Centro de Pesquisas Clinicas em Oncologia - CPCOCachoeiro de Itapemirim, Espírito Santo
- Oncovida*XSalvador, Estado de Bahia
- Instituto Nacional de Cancer - INCa; OncologiaRio de Janeiro, Rio de Janeiro
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 15, 2023. Always confirm current availability with the study team.