(TESSERACT): Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation (TBI)
Vanderbilt-Ingram Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVES: I. Evaluate the safety of the addition of total body irradiation (TBI) and hypo-fractionated radiation (H-RT) to atezolizumab and chemotherapy in patients with extensive stage-small cell lung carcinoma (ES-SCLC). II. Evaluate the efficacy of the addition of TBI and H-RT to atezolizumab and chemotherapy in patients with ES-SCLC. SECONDARY OBJECTIVE: I. Evaluate the progression free survival benefit and local and systemic control benefits of the addition of TBI and H-RT to atezolizumab and chemotherapy in patients with ES-SCLC. OUTLINE: INDUCTION PHASE: Patients receive…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years at time of informed consent * Histologically documented or cytologically confirmed diagnosis of extensive stage small-celllung cancer with evaluable disease per RECIST v1.1 criteria. Patients may be considered extensive-stage based on M1 disease per AJCC 8th edition, OR may be clinically staged as extensive-stage disease based on anatomical extent that would preclude the use of standard radiotherapy fields as assessed by the treating radiation oncologist. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Absolute neutrophil count (ANC…
Interventions
- DrugCarboplatin
Given by IV
- BiologicalAtezolizumab
Given by IV
- DrugEtoposide
Given by IV
- RadiationTotal Body Irradiation
Undergo Total Body Irradiation
- RadiationHypofractionated Radiation Therapy
Undergo Hypofractionated Radiation Therapy
- ProcedureMagnetic Resonance Imaging
Undergo Magnetic Resonance Imaging
Location
- Vanderbilt University/Ingram Cancer CenterNashville, Tennessee