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Recruiting NCT04691817

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

Phase I / Phase II Interventional Lung Cancer, Nonsmall Cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atezolizumab, Tocilizumab.
Who it may be relevant to
Registry conditions: Lung Cancer, Nonsmall Cell. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Atezolizumab
    1200mg infusion
  • Drug Tocilizumab
    Tocilizumab 6mg/kg or 4mg/kg infusion

Primary outcome measures

  • Overall response rate (ORR) [Time frame: From first dose of protocol treatment until radiologic disease assessment at 12 weeks.]
Secondary outcome measures (3)
  • Overall survival (OS) [Time frame: 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 [Time frame: From first dose of protocol treatment until 49 days post treatment]
  • Progression free survival (PFS). [Time frame: 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Abramson Cancer Center of the University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT04691817 · UPCC 16520

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗