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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04691817
Recruitment Status : Not yet recruiting
First Posted : December 31, 2020
Last Update Posted : October 7, 2021
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer, Nonsmall Cell Drug: Atezolizumab Drug: Tocilizumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Atezolizumab and Tocilizumab
Participants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days
 Drug: Atezolizumab
1200mg infusion
Other Name: Tecentriq

Drug: Tocilizumab
Tocilizumab 6mg/kg or 4mg/kg infusion
Other Name: Actemra, RoActemra, RO4877533


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. ]
    Estimate the time from first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure

  2. Dose Limiting Toxicities of the combination [ Time Frame: From first dose of protocol treatment until 49 days post treatment ]
    Determine dose limiting toxicities of the combination

  3. 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. ]
    Estimate the time from first dose of protocol treatment until first radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if there is no progression date registered.


Other Outcome Measures:
  1. Clinical outcomes [ Time Frame: From enrollment until dealth due to any cause or last patient contact alive until 3 months after study closure ]
    Correlate clinical outcomes with potential markers of immune escape and changes in the tumor microenvironment and blood using a novel field theory based methods under development by Cold Spring Harbor Laboratory.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691817


Contacts
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Contact: Melissa Volpe, BA 215-220-9703 melissa.volpe@pennmedicine.upenn.edu
Contact: Melina Marmarelis, MD, MSCE 215-615-5835 melina.marmarelis@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Contact: Mel V, BA    215-220-9703    Melissa.volpe@pennmedicine.upenn.edu   
Principal Investigator: Melina Marmarelis, MD, MSCE         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Genentech, Inc.
Investigators
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Principal Investigator: Melina Marmarelis, MD, MSCE Abramson Cancer Center of the University of Pennsylvania
More Information
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04691817    
Other Study ID Numbers: UPCC 16520
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Atezolizumab
Antineoplastic Agents