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

Lung Cancer, Nonsmall Cell Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691817
• Other study ID #: UPCC 16520
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 25, 2023
• Est. completion date: September 2026

Study information

• Verified date: July 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Melissa Volpe, BA
• Phone: 215-220-9703
• Email: melissa.volpe[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: September 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Nonsmall Cell
• Lung Neoplasms

Intervention

Drug:
• Atezolizumab
1200mg infusion
• Tocilizumab
Tocilizumab 6mg/kg or 4mg/kg infusion

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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.
Secondary	Dose Limiting Toxicities of the combination	Determine dose limiting toxicities of the combination	From first dose of protocol treatment until 49 days post treatment
Secondary	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.