A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab
Intervention description: Atezolizumab 1200 mg was administered by intravenous infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Intervention MeSH terms: Atezolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a Phase II, open-label, prospective, multicenter study designed to evaluate the
      efficacy and safety of single-agent atezolizumab as a first-line therapy in participants with
      locally advanced or metastatic non-small cell lung cancer (NSCLC). In addition, the primary
      biomarker objective was to measure blood tumor mutational burden (bTMB) and evaluate whether
      it can predict for improved clinical outcome with atezolizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Histologically or cytologically confirmed Stage IIIB-IVB NSCLC

          -  For participants who have received prior neo-adjuvant/adjuvant chemotherapy or
             chemoradiotherapy with curative intent for non-metastatic disease: a treatment-free
             interval of at least 6 months prior to enrollment

          -  Participants with any programmed death-ligand 1 (PD-L1) test result by
             immunohistochemistry (IHC) are eligible for the study

          -  Participants without a PD-L1 test result are eligible for the study

          -  Measurable disease per RECIST v1.1

          -  Adequate hematologic and end-organ function

          -  Agreement to remain abstinent (refrain from heterosexual intercourse) or use
             contraceptive methods among women of childbearing potential

        Exclusion Criteria:

          -  Prior treatment with immunotherapy for any stage NSCLC, including early-stage
             (neoadjuvant or adjuvant) disease

          -  Participants with epidermal growth factor receptor (EGFR) sensitizing mutations and
             anaplastic lymphoma kinase (ALK) rearrangements

          -  Active central nervous system (CNS) metastases requiring treatment

          -  Spinal cord compression not definitively treated or not clinically stable

          -  Leptomeningeal disease

          -  Uncontrolled tumor-related pain

          -  Uncontrolled pleural, pericardial effusions, or ascites requiring recurrent drainage
             procedures

          -  Uncontrolled or symptomatic hypercalcemia

          -  Malignancies other than NSCLC within 5 years prior to enrollment, except for those
             curatively treated with negligible risk of metastasis or death

          -  Pregnant or lactating women

          -  History of autoimmune disease, significant pulmonary disease, or significant
             cardiovascular disease

          -  Positive human immunodeficiency virus (HIV) or hepatitis B or C

          -  Active tuberculosis

          -  Severe infection or major surgery within 4 weeks, or oral or IV antibiotics treatment
             within 2 weeks prior to enrollment

          -  Prior treatment with or hypersensitivity to study drug or related compounds

          -  Prior allogeneic bone marrow or solid organ transplant

          -  Administration of a live, attenuated vaccine within 4 weeks prior to enrollment

          -  Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the
             drug (whichever is longer) prior to enrollment

          -  Treatment with systemic corticosteroids or other systemic immunosuppressive
             medications within 2 weeks prior to enrollment