Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC

Exclusion Criteria

• •Illness or condition that may interfere with a patient's capacity to understand, follow, and/or comply with study procedures
• •Treatment in any other clinical trial within 30 days before screening.
• •NSCLC Stage cT4
• •NSCLC stage cN3 or cN2 IIIA4 (bulky or fixed multi-station N2 disease) according to Robinson classification
• •NSCLC of squamous cell histology
• •Any prior therapy for lung cancer (including systemic therapy, radiotherapy or major surgery)
• •Malignancies other than NSCLC within 5 years prior to study inclusion with the exception of malignancies with a negligible risk of metastasis or death (5-year OS \> 90%) like localized prostate cancer, ductal carcinoma in situ, adequately treated carcinoma in situ of the cervix, Stage I uterine cancer or non-melanoma skin carcinoma
• •History of allogeneic tissue / solid organ transplant or allogeneic stem cell transplantation
• •Patients with active hepatitis B or C infections or a history of HIV infection
• •Pregnant or lactating women
• •Active autoimmune disease or history of severe autoimmune disease or immunodeficiency or a syndrome that requires systemic steroids or immunosuppressive agents
• •The following exceptions are granted:
• •* patients with vitiligo, eczema, lichen simplex or resolved childhood asthma/atopy
• •* subjects requiring intermittent use of bronchodilatators or local steroid injections
• •* patients with hypothyroidism stable on hormone replacement
• •Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1 (except low-dose steroids for adrenal failure or emesis prophylaxis)
• •History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, drug-induced pneumonitis, or evidence 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
• •Live vaccine within 30 days prior to first dose of trial treatment
• •Cerebrovascular accident within the past 6 months
• •Severe infection or significant traumatic injury within the past 4 weeks
• •Clinically significant history of cardiovascular disease, including any of the following:
• •* Myocardial infarction or unstable angina within the past 6 months
• •* New York Heart Association class II, III-IV congestive heart failure
• •* Poorly controlled cardiac arrhythmia despite medication, except rate-controlled atrial fibrillation
• •Known allergy or hypersensitivity to any component of the chemotherapy regimen Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities, as well as patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial