Actively Recruiting
Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation
Led by Vanderbilt-Ingram Cancer Center · Updated on 2024-06-20
18
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt-Ingram Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/II trial studies the side effects, safety, and effectiveness of low dose radiation to the entire body (total body irradiation \[TBI\]) and higher dose radiation to known areas of cancer (hypofractionated radiation therapy \[H-RT\]) combined with atezolizumab and chemotherapy (carboplatin \& etoposide) in treating patients with small cell lung cancer that has spread to disease sites outside of the lung (extensive stage). Extensive stage disease has historically been treated with chemotherapy alone with consideration of chest (thoracic) radiation therapy for those with response to chemotherapy, as well as consideration of preventative radiation therapy to the head (prophylactic cranial irradiation). Emerging evidence supports the synergistic interactions between immunotherapy and radiation therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Combining TBI and H-RT with atezolizumab and chemotherapy may improve response to treatment.
CONDITIONS
Official Title
Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of informed consent
- Histologically or cytologically confirmed extensive stage small cell lung cancer with measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Absolute neutrophil count of at least 1.5 x 10^9/L
- Platelet count of at least 100 x 10^9/L
- Lymphocyte count of at least 0.5 x 10^9/L
- Hemoglobin level of at least 9 g/dL
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase less than or equal to 2.5 times the upper limit of normal
- Creatinine less than or equal to 1.5 times the upper limit of normal or creatinine clearance at least 50 mL/min
- International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) less than or equal to 1.5 times the upper limit of normal unless receiving stable anticoagulation therapy
- Negative HIV test or stable HIV on antiretroviral therapy with CD4 count at least 200 and undetectable viral load
- Negative Hepatitis B surface antigen test
- Brain metastases allowed if managed and asymptomatic
- Use of contraception as recommended during treatment and for 5 months after last dose of atezolizumab
- Female patients must not be pregnant or breastfeeding
- Eligible for immunotherapy-based treatment per physician judgment
- Able to provide written informed consent
You will not qualify if you...
- Major surgery requiring general anesthesia within 4 weeks before enrollment
- Clinically significant acute or chronic infections including untreated hepatitis B or active tuberculosis
- Significant cardiovascular disease within 3 months before treatment
- Uncontrolled hypertension despite medical therapy
- Prior malignancy within 3 years except certain low-risk cancers
- Prior chemotherapy or immunotherapy for current cancer except 1 cycle of first-line therapy
- Prior radiotherapy preventing protocol-based radiation delivery
- Receipt of live attenuated vaccine within 28 days before treatment and during study
- Use of prohibited drugs or enrollment in another interventional clinical trial
- Known malignant pleural effusions or uncontrolled fluid requiring frequent drainage
- History of leptomeningeal disease
- Uncontrolled tumor-related pain or symptomatic lesions needing urgent treatment
- Uncontrolled or symptomatic high calcium levels
- Active or history of autoimmune or immune deficiency disorders with some exceptions
- History or evidence of pneumonitis or pulmonary fibrosis
- Severe infection within 4 weeks prior to treatment
- Recent therapeutic antibiotic treatment within 2 weeks before treatment
- Prior organ or stem cell transplant
- Any condition that contraindicates investigational drug use or affects study results
- Treatment with investigational therapy within 28 days before study
- Prior treatment with immune checkpoint inhibitors or CD137 agonists
- Recent use of systemic immunostimulatory or immunosuppressive medications with some exceptions
- History of severe allergic reactions to similar antibodies
- Known hypersensitivity to components of atezolizumab
- Pregnancy, breastfeeding, or intention to become pregnant during or shortly after study treatment
- Women of childbearing potential must have negative pregnancy test within 14 days before treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
V
Vanderbilt-Ingram Services for Timely Access
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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