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]

  • Interventional
  • Not Recruiting
  • NCT02367794
Eligibility Details Visit Clinicaltrials.gov

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02367794

IRB#IRB15-0395

Lead SponsorHoffmann-La Roche

Lead PhysicianPhilip Charles Hoffman

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting