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

Primary Purpose

Lung Cancer, Nonsmall Cell

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Atezolizumab

Tocilizumab

About this trial

This is an interventional treatment trial for Lung Cancer, Nonsmall Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Abramson Cancer Center of the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atezolizumab and Tocilizumab

Arm Description

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

Outcomes

Primary Outcome Measures

Overall response rate (ORR)

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

Secondary Outcome Measures

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

Dose Limiting Toxicities of the combination

Determine dose limiting toxicities of the combination

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.

Full Information

NCT ID

NCT04691817

First Posted

December 8, 2020

Last Updated

July 26, 2023

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04691817

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 25, 2023 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Nonsmall Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Atezolizumab and Tocilizumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Atezolizumab

Other Intervention Name(s)

Tecentriq

Intervention Description

1200mg infusion

Intervention Type

Drug

Intervention Name(s)

Tocilizumab

Other Intervention Name(s)

Actemra, RoActemra, RO4877533

Intervention Description

Tocilizumab 6mg/kg or 4mg/kg infusion

Primary Outcome Measure Information:

Title

Overall response rate (ORR)

Description

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 Outcome Measure Information:

Title

Overall survival (OS)

Description

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.

Title

Dose Limiting Toxicities of the combination

Description

Determine dose limiting toxicities of the combination

Time Frame

From first dose of protocol treatment until 49 days post treatment

Title

Progression free survival (PFS).

Description

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 Pre-specified Outcome Measures:

Title

Clinical outcomes

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa Volpe, BA

Phone

215-220-9703

melissa.volpe@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Melina Marmarelis, MD, MSCE

Phone

215-615-5835

melina.marmarelis@pennmedicine.upenn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melina Marmarelis, MD, MSCE

Organizational Affiliation

Abramson Cancer Center at Penn Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abramson Cancer Center of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mel V, BA

Phone

215-220-9703

Melissa.volpe@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name & Degree

Melina Marmarelis, MD, MSCE

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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