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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT04691817Sponsor: Abramson Cancer Center at Penn MedicineLast updated: 2026-01-07

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.

Arms & interventions

  • DrugAtezolizumab

    1200mg infusion

  • DrugTocilizumab

    Tocilizumab 6mg/kg or 4mg/kg infusion

Outcome measures

Primary

  • 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

  • Overall survival (OS)

    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

    Time frame: From first dose of protocol treatment until 49 days post treatment

  • Progression free survival (PFS).

    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.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Melina Marmarelis, MD, MSCE · Principal Investigator