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]
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/11/2019 |
Start Date: | July 20, 2015 |
End Date: | April 23, 2020 |
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
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.
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.
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
We found this trial at
22
sites
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Straub Clinic And Hospital Founded in 1921, Straub Clinic & Hospital is a fully integrated...
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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719 Thompson Ln
Nashville, Tennessee 37204
Nashville, Tennessee 37204
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