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

Abramson Cancer Center at Penn Medicine

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Lung Cancer, Nonsmall Cell

Treatments: Drug: Tocilizumab; Drug: Atezolizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04691817

UPCC 16520

Details and patient eligibility

About

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

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Atezolizumab and Tocilizumab

Experimental group

Description:

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

Treatment:

Drug: Atezolizumab

Drug: Tocilizumab