Combining tocilizumab and atezolizumab for advanced lung cancer after previous treatments
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
This study is testing if combining two medications, tocilizumab and atezolizumab, can help adults with advanced lung cancer that hasn't improved with previous treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | immunotherapy, tocilizumab, atezolizumab |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04691817 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of tocilizumab in combination with atezolizumab for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has not responded to prior immune checkpoint inhibitor therapy. Participants must have advanced non-squamous NSCLC and have received at least one line of therapy before enrolling. The study aims to determine how well this combination therapy works in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with advanced non-squamous NSCLC who have previously received at least one line of therapy, including a checkpoint inhibitor.
Not a fit: Patients with driver mutations susceptible to targeted therapy or those with uncontrolled tumor-related pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung cancer who have limited treatment alternatives.
How similar studies have performed: Other studies have shown promise in using combination therapies for lung cancer, but this specific combination is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Melina Marmarelis, MD, MSCE — Abramson Cancer Center at Penn Medicine
- Study coordinator: Melissa Volpe, BA
- Email: melissa.volpe@pennmedicine.upenn.edu
- Phone: 215-220-9703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.