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

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

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

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer, Nonsmall Cell
• Intervention / Treatment: Drug: Atezolizumab; Drug: Tocilizumab

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Melissa Volpe, BA; Phone Number: 215-220-9703; Email: Melissa.volpe@pennmedicine.upenn.edu
• Study Contact Backup: Name: Melina Marmarelis, MD, MSCE; Phone Number: 215-615-5835; Email: melina.marmarelis@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center of the University of Pennsylvania
      • Contact: Mel V, BA; Phone Number: 215-220-9703; Email: Melissa.volpe@pennmedicine.upenn.edu
      • Principal Investigator: Melina Marmarelis, MD, MSCE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Tecentriq; Drug: Tocilizumab; Tocilizumab 6mg/kg or 4mg/kg infusion; Other Names: Actemra, RoActemra, RO4877533

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks.	From first dose of protocol treatment until radiologic disease assessment at 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	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	From first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure.
Dose Limiting Toxicities of the combination	Determine dose limiting toxicities of the combination	From first dose of protocol treatment until 49 days post treatment
Progression free survival (PFS).	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.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes	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.	From enrollment until dealth due to any cause or last patient contact alive until 3 months after study closure

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Melina Marmarelis, MD, MSCE, Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Atezolizumab
• Other Study ID Numbers: UPCC 16520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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