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 | Recruiting Phase 1 FDA Drug

• 1 other identifier: UPCC 16520
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival (OS)

  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

  From first dose of protocol treatment until 49 days post treatment

• Progression free survival (PFS).

  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 Outcomes (1)

• Clinical outcomes

  From enrollment until dealth due to any cause or last patient contact alive until 3 months after study closure

Study Arms (1)

Atezolizumab and Tocilizumab

EXPERIMENTAL

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

Drug: Atezolizumab; Drug: Tocilizumab

Interventions

Atezolizumab DRUG

1200mg infusion

Also known as: Tecentriq

Atezolizumab and Tocilizumab

Tocilizumab DRUG

Tocilizumab 6mg/kg or 4mg/kg infusion

Also known as: Actemra, RoActemra, RO4877533

Atezolizumab and Tocilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: collaborator
• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab; tocilizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Melina Marmarelis, MD, MSCE

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Volpe, BA

CONTACT

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

Melina Marmarelis, MD, MSCE

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 31, 2020
• Study Start: July 25, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)