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

Phase 1

Recruiting

• Conditions: Lung Cancer, Nonsmall Cell
• Interventions: Drug: Atezolizumab; Drug: Tocilizumab

• Registration Number: NCT04691817
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2020-12-31
• Study Start: 2023-07-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-12
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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
Dose Limiting Toxicities of the combination	From first dose of protocol treatment until 49 days post treatment	Determine dose limiting toxicities of the combination

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States