NCT06110572

Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation

(TESSERACT): Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation (TBI)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 carboplatin intravenously (IV) and atezolizumab IV on day 1 of each cycle and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive TBI twice daily (BID) on day 18 or 19 of cycle 1 and beginning 2-3 days later, H-RT daily over 7 days in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive atezolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the trial. After completion of study treatment, patients are followed up within 30 days and then every 3-4 months for up to 3 years.

Conditions

• Extensive Stage Lung Small Cell Carcinoma
• Stage IV Lung Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Given by IV
BIOLOGICAL	Atezolizumab	Given by IV
DRUG	Etoposide	Given by IV
RADIATION	Total Body Irradiation	Undergo Total Body Irradiation
RADIATION	Hypofractionated Radiation Therapy	Undergo Hypofractionated Radiation Therapy
PROCEDURE	Magnetic Resonance Imaging	Undergo Magnetic Resonance Imaging

Timeline

• Start date: 2024-04-24
• Primary completion: 2027-06-30
• Completion: 2028-06-30
• First posted: 2023-10-31
• Last updated: 2024-06-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study