RECRUITING

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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Conditions

Lung Cancer, Nonsmall Cell

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-07-25
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04691817

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
  2. * Prior exposure to at least 1 line of therapy
  3. * Exposure to a including checkpoint inhibitor in line of therapy immediately prior to enrollment on trial
  4. * ECOG PS 0-2
  1. * Presence of a driver mutation that is susceptible to targeted therapy
  2. * No greater than CTCAE v5 grade 3 toxicity attributed to prior immunotherapy
  3. * Other active invasive malignancy requiring ongoing therapy
  4. * Evidence of progressing or untreated brain metastases
  5. * Evidence or history of leptomeningeal disease
  6. * Uncontrolled tumor related pain
  7. * History of an autoimmune disease or IPF

Contacts and Locations

Study Contact

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

Principal Investigator

Melina Marmarelis, MD, MSCE
PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine

Study Locations (Sites)

Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

  • Melina Marmarelis, MD, MSCE, PRINCIPAL_INVESTIGATOR, Abramson Cancer Center at Penn Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-25
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-07-25
Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Cancer, Nonsmall Cell