A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

  • Interventional
  • Not Recruiting
  • NCT02366143
Eligibility Details Visit Clinicaltrials.gov

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Eastern Cooperative Oncology Group performance status 0 or 1

         - Histologically or cytologically confirmed, Stage IV non-squamous NSCLC

         - Participants with no prior treatment for Stage IV non-squamous NSCLC

         - Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening

         - Measurable disease as defined by RECIST v1.1

         - Adequate hematologic and end organ function

        Exclusion Criteria:

        Cancer-Specific Exclusions:

         - Active or untreated central nervous system metastases

         - 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

        General Medical Exclusions:

         - 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 scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted

         - Positive test for human immunodeficiency virus

         - Active hepatitis B or hepatitis C

         - Severe infection within 4 weeks prior to randomization

         - Significant cardiovascular disease

         - Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures

        Exclusion Criteria Related to Medications:

         - Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies

At a Glance

National Government IDNCT02366143

IRB#IRB15-0380

Lead SponsorHoffmann-La Roche

Lead PhysicianPhilip Charles Hoffman

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting