A Phase III, Open-Label, Randomized Study of 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 (NSCLC)

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

A Phase III, Open-Label, Randomized Study of 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 (NSCLC)

Description

This randomized, open-label study will evaluate the safety and efficacy of Atezolizumab (MPDL3280A) in combination with carboplatin and paclitaxel with or without bevacizumab compared with treatment with carboplatin plus (+) paclitaxel and bevacizumab in chemotherapy-naïve patients with Stage IV non-squamous non-small cell lung cancer (NSCLC).

Details
Clinical Study IdentifierTX141310
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years of age or older
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Histologically or cytologically confirmed, treatment-naïve Stage IV non-squamous NSCLC
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

Active or untreated central nervous system (CNS) 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
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 CD137 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
Clear my responses

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