Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy

Study Overview
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Brief Summary
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This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.

Official Title
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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

Conditions
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Lung Cancer, Nonsmall Cell

Intervention / Treatment
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* Drug: Atezolizumab
* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atezolizumab and Tocilizumab<br>Participants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days | Drug: Atezolizumab<br>* 1200mg infusion<br>* Other names: Tecentriq;Drug: Tocilizumab<br>* Tocilizumab 6mg/kg or 4mg/kg infusion<br>* Other names: Actemra, RoActemra, RO4877533;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks. | From first dose of protocol treatment until radiologic disease assessment at 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | From first dose of protocol treatment until 49 days post treatment | 
| 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. | 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. |