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Recruiting

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

NCT04691817 · Abramson Cancer Center at Penn Medicine
In plain English

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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
About this study
This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.
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
Study design
Enrollment target: 28 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-07-25
Estimated completion: 2027-09
Last updated: 2026-01-07
Interventions
Drug: AtezolizumabDrug: Tocilizumab
Primary outcomes
  • Overall response rate (ORR) (From first dose of protocol treatment until radiologic disease assessment at 12 weeks.)
Sponsor
Abramson Cancer Center at Penn Medicine · other
With: Genentech, Inc.
Contacts & investigators
ContactMelissa Volpe, BA · contact · melissa.volpe@pennmedicine.upenn.edu · 215-220-9703
ContactMelina Marmarelis, MD, MSCE · contact · melina.marmarelis@pennmedicine.upenn.edu · 215-615-5835
InvestigatorMelina Marmarelis, MD, MSCE · principal_investigator, Abramson Cancer Center at Penn Medicine
All locations (1)
Abramson Cancer Center of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy · TrialPath