A Phase Ib-II Trial of Tocilizumab and Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy
Summary
This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.
Arms & interventions
- DrugAtezolizumab
1200mg infusion
- DrugTocilizumab
Tocilizumab 6mg/kg or 4mg/kg infusion
Outcome measures
Primary
Overall response rate (ORR)
Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks.
Time frame: From first dose of protocol treatment until radiologic disease assessment at 12 weeks.
Secondary
Overall survival (OS)
Time frame: From first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure.
Dose Limiting Toxicities of the combination
Time frame: From first dose of protocol treatment until 49 days post treatment
Progression free survival (PFS).
Time frame: From 1st dose of treatment until 1st radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if no progression date registered, assessed up to 24 months.
Eligibility criteria
Study locations (1)
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104