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

NCT ID: NCT04691817

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-25

Study Completion Date

2027-09-30

Brief Summary

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

Detailed Description

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Conditions

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Lung Cancer, Nonsmall Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atezolizumab and Tocilizumab

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

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type DRUG

1200mg infusion

Tocilizumab

Intervention Type DRUG

Tocilizumab 6mg/kg or 4mg/kg infusion

Interventions

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Atezolizumab

1200mg infusion

Intervention Type DRUG

Tocilizumab

Tocilizumab 6mg/kg or 4mg/kg infusion

Intervention Type DRUG

Other Intervention Names

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Tecentriq Actemra, RoActemra, RO4877533

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melina Marmarelis, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Melissa Volpe, BA

Role: CONTACT

215-220-9703

Melina Marmarelis, MD, MSCE

Role: CONTACT

215-615-5835

Facility Contacts

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Mel V, BA

Role: primary

215-220-9703

Other Identifiers

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UPCC 16520

Identifier Type: -

Identifier Source: org_study_id

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