NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

NCT02367794

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Squamous Non-Small Cell Lung Cancer

Interventions: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody, Carboplatin, Nab-Paclitaxel, Paclitaxel

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
* Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and end organ function

Exclusion Criteria:

* Active or untreated central nervous system (CNS) metastasis
* 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 Computed Tomography (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 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
* Severe infection within 4 weeks prior to randomization
* Significant history of cardiovascular disease

Locations (242)

Chandler, Arizona, United States
Springdale, Arkansas, United States
Bellflower, California, United States
Oakland, California, United States
Sacramento, California, United States
San Leandro, California, United States
Santa Clara, California, United States
Vallejo, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Danbury, Connecticut, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Palm Beach Gardens, Florida, United States
Port Saint Lucie, Florida, United States
St. Petersburg, Florida, United States
Athens, Georgia, United States
Carrollton, Georgia, United States
Macon, Georgia, United States
Newnan, Georgia, United States
Chicago, Illinois, United States
Joliet, Illinois, United States
Quincy, Illinois, United States
Fort Wayne, Indiana, United States
Bettendorf, Iowa, United States
Sioux City, Iowa, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Scarborough, Maine, United States
+ 212 more on CT.gov