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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] | Clinical Trials | Clareo Health

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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]

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

NCT02409342•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+1 more criteria

Locations (142)

University of California San Diego

La Jolla, California, United States

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

Key Dates

Start Date

July 20, 2015

Primary Completion Date

February 4, 2020

Completion Date

March 8, 2022

Last Updated

March 15, 2023

Enrollment

572

ACTUAL participants

Conditions

Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer

Interventions

Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

DRUG

Carboplatin

DRUG

Cisplatin

DRUG

Gemcitabine

DRUG

Pemetrexed

DRUG