Recruiting
Phase 1
Phase 2

Tocilizumab & Atezolizumab

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT04691817

Conditions

Lung Cancer, Nonsmall Cell

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atezolizumab

Tocilizumab

Study Details

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.

Conditions

Lung Cancer, Nonsmall Cell

Study ID

NCT04691817

Start date

Jul 25, 2023

Status verified date

Jan, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Atezolizumab and Tocilizumab

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

Interventions

Atezolizumab

1200mg infusion

Tocilizumab

Tocilizumab 6mg/kg or 4mg/kg infusion

Primary outcome measure

  • Overall response rate (ORR) [ Time Frame: From first dose of protocol treatment until radiologic disease assessment at 12 weeks. ]

Central Contacts and Locations

Central contacts

Melissa Volpe, BA

215-220-9703melissa.volpe@pennmedicine.upenn.edu

Melina Marmarelis, MD, MSCE

215-615-5835melina.marmarelis@pennmedicine.upenn.edu

Locations

Abramson Cancer Center of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Mel V, BA

215-220-9703Melissa.volpe@pennmedicine.upenn.edu

Principal Investigator:

Melina Marmarelis, MD, MSCE

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-01-07.