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

Abramson Cancer Center at Penn Medicine2 sites in 1 country28 target enrollmentJuly 25, 2023

ConditionsLung Cancer, Nonsmall Cell

InterventionsAtezolizumab Tocilizumab

DrugsAtezolizumab Tocilizumab

Overview

Phase: Phase 1
Intervention: Atezolizumab
Conditions: Lung Cancer, Nonsmall Cell
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 28
Locations: 2
Primary Endpoint: Overall response rate (ORR)
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 25, 2023

End Date

September 1, 2027

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Atezolizumab and Tocilizumab

Participants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days

Intervention: Atezolizumab

Atezolizumab and Tocilizumab

Participants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days

Intervention: Tocilizumab

Outcomes

Primary Outcomes

Overall response rate (ORR)

Time Frame: 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 Outcomes

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.)
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.)
Dose Limiting Toxicities of the combination(From first dose of protocol treatment until 49 days post treatment)