A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally 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; rHuPH20
Intervention description: Atezolizumab will be administered as per the schedule specified in arm or cohort.; rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
Intervention MeSH terms: Atezolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Intervention study model can be sequential or in parallel.
Masking: None (Open Label)
Enrollment: 438.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab
      subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally
      advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer
      immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is
      comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to
      identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part
      2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields
      drug exposure that is comparable to that of atezolizumab IV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically documented locally advanced or metastatic NSCLC

          -  Prior platinum-containing regimen or disease recurrence ≤ 6 months since prior
             platinum-based adjuvant/neoadjuvant regimen.

          -  Measurable disease as defined by RECIST v1.1

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Life expectancy ≥12 weeks

          -  Adequate hematologic and end-organ function

        Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known epidermal
        growth factor receptor (EGFR) status

        Exclusion Criteria:

          -  Symptomatic, untreated, or actively progressing central nervous system (CNS)
             metastases

          -  Uncontrolled or symptomatic hypercalcemia

          -  Pregnancy or breastfeeding

          -  Active or history of autoimmune disease or immune deficiency

          -  History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
             pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis

          -  Severe infection ≤ 4 weeks

          -  Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to study treatment

          -  Significant cardiovascular disease

          -  Prior allogeneic stem cell or solid organ transplantation

          -  Treatment with a live, attenuated vaccine ≤ 4 weeks

          -  Treatment with systemic immunostimulatory agents ≤ 4 weeks or 5 half-lives of the drug

          -  Treatment with systemic immunosuppressive medication ≤ 2 weeks

        Additional Exclusion Criteria (Part 2 Only)

        • Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to
        treat the patient if positive