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Sponsor: Hoffmann-La Roche
Conditions: Non-Small-Cell Lung
Interventions: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Placebo Comparator, Nab-paclitaxel, Pemetrexed, Carboplatin
Countries: United States, Australia, Austria, Brazil, China, France, Germany, Hungary
This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the AJCC/UICC staging system * Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent * Adequate pulmonary and cardiac function to undergo surgical resection * Measurable disease as defined by RECIST v1.1 * Adequate hematologic and end organ function * Negative HIV test at screening * Negative for active HBV and HCV at screening * Adequate tissue for PD-L1 IHC assessment Exclusion criteria: * NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma * Mixed NSCLC and small cell lung cancer histology * Any prior therapy for lung cancer * Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated expected curative outcome * Non-squamous NSCLC histology with activating ALK and EGFR mutation * Pregnant or lactating women * History of autoimmune disease * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest Computed Tomography (CT) scan * Prior treatment with cluster of differentiation 137 (CD137) agonist 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
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- Kogarah, New South Wales, Australia
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