RecruitingRecruiting
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