About this trial
This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
Prior exposure to at least 1 line of therapy
Exposure to a including checkpoint inhibitor in line of therapy immediately prior to enrollment on trial
ECOG PS 0-2
Disqualifiers
Presence of a driver mutation that is susceptible to targeted therapy
No greater than CTCAE v5 grade 3 toxicity attributed to prior immunotherapy
Other active invasive malignancy requiring ongoing therapy
Evidence of progressing or untreated brain metastases
Trial design
Single group
Treatments tested in this trial
Atezolizumab
Drug1200mg infusion
Tocilizumab
DrugTocilizumab 6mg/kg or 4mg/kg infusion
Treatment groups
Trial outcomes
Primary outcomes
Overall response rate (ORR)
Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks.
Secondary outcomes
Overall survival (OS)
Estimate the time 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
Determine dose limiting toxicities of the combination
Progression free survival (PFS).
Estimate the time from first dose of protocol treatment until first radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if there is no progression date registered.
Other outcomes
Clinical outcomes
Correlate clinical outcomes with potential markers of immune escape and changes in the tumor microenvironment and blood using a novel field theory based methods under development by Cold Spring Harbor Laboratory.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
Genentech, Inc.
Collaborator