Lung Cancer, Nonsmall Cell
Conditions
Brief 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.
Interventions
DRUGAtezolizumab
1200mg infusion
DRUGTocilizumab
Tocilizumab 6mg/kg or 4mg/kg infusion
Sponsors
Genentech, Inc.
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Evidence or history of leptomeningeal disease * Uncontrolled tumor related pain * History of an autoimmune disease or IPF
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | From first dose of protocol treatment until radiologic disease assessment at 12 weeks. | Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | From first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure. | 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 | From first dose of protocol treatment until 49 days post treatment | Determine dose limiting toxicities of the combination |
| Progression free survival (PFS). | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes | From enrollment until dealth due to any cause or last patient contact alive until 3 months after study closure | 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. |
Countries
United States
Contacts
Primary ContactMelissa Volpe, BA
Backup ContactMelina Marmarelis, MD, MSCE
Outcome results
None listed