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 2RecruitingNCT04691817

Abramson Cancer Center at Penn Medicine28 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer, Nonsmall Cell

Interventions

AtezolizumabDRUG

1200mg infusion

TocilizumabDRUG

Tocilizumab 6mg/kg or 4mg/kg infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Overall response rate (ORR)

Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks.

Time frame: From first dose of protocol treatment until radiologic disease assessment at 12 weeks.

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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.

Central 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

Data from ClinicalTrials.gov

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