Evaluating the Efficacy of Atezolizumab in Advanced Non-small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• Patients with Stage IIIB/IV squamous or non-squamous NSCLC (American Joint Committee on Cancer 7th Edition Staging) who have had prior treatment with nivolumab or pembrolizumab will be enrolled in one of 3 parallel cohorts based on the following:
• Cohort 1: Patient with progressive disease on nivolumab or pembrolizumab as the best overall response. Progressive disease must be confirmed with a confirmatory scan ≤ 4 weeks after the 1st documented date of progression.
• Cohort 2: Patients with stable disease as the best overall response on a minimum of 12 weeks of therapy with nivolumab or pembrolizumab.
• Cohort 3: Patients with partial or complete response as the best overall response followed by progressive disease, on nivolumab or pembrolizumab. A confirmatory scan at the time of disease progression must be performed ≤ 4 weeks after the 1st documented date of progression.
• Both men and women of all races and ethnic groups are eligible for this trial
• Patients must have resolution of toxic effects to Grade 1 or less from prior therapy (except alopecia).
• Patients must sign Informed Consent Form and show ability and willingness to comply with the requirements of the study protocol.
• 18 years of age or older
• Willingness to undergo a biopsy ≤ 6 weeks of the start of study treatment to obtain formalin-fixed paraffin-embedded tumor specimens in paraffin blocks (blocks are preferred) or at least 15 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression.
• Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1):
• ANC equal to/greater than 1500 cells/µL
• WBC counts greater than 2500/µL
• Lymphocyte count equal to/greater than 300µ/L
• Platelet count equal to/greater than 100,000/µL
• Hemoglobin equal to/greater than 9.0 g/dL
• Total bilirubin equal to/less than 1.5 x ULN with the following exception:
• Patients with known Gilbert disease who have serum bilirubin level equal to/less than 3 x ULN may be enrolled.
• AST and ALT equal to/less than 3.0 x ULN with the following exception:
• Patients with liver involvement: AST and/or ALT equal to/less than 5 x ULN
• Alkaline phosphatase equal to/less than 2.5 x ULN with the following exception:
• Patients with documented liver involvement or bone metastases: alkaline phosphatase equal to/less than 5 x ULN
• Serum creatinine equal to/less than 1.5 x ULN or creatinine clearance equal to/greater than 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation.
• Measurable disease per RECIST v1.1 for patients with solid malignancies.
• For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [less than 1% per year] when used consistently and correctly) and to continue its use for 5 months after the last dose of Atezolizumab.
• Eastern Cooperative Oncology Group Performance Status of 0 or 1. Patients with an ECOG Performance Status of 2 will be allowed at the discretion of the Treating Investigator in agreement with the Sponsor-Investigator.
• INR and aPTT equal to/less than 1.5 x ULN. This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose.

Exclusion Criteria

• Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:
• Hormone-replacement therapy or oral contraceptives.
• Herbal therapy greater than 1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1, Da