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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Atezolizumab

    Drug

    1200mg infusion

  • Tocilizumab

    Drug

    Tocilizumab 6mg/kg or 4mg/kg infusion

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Atezolizumab and TocilizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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.
2

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
3

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.

Other outcomes

1

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.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.