RecruitingPhase 1Phase 2NCT06110572

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)


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

18 participants

Start Date

Apr 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a specialized full-body radiation treatment (called TESSERACT) to the standard first-line therapy of atezolizumab (immunotherapy) plus chemotherapy improves outcomes in patients with extensive-stage small cell lung cancer (SCLC), an aggressive form of lung cancer. **You may be eligible if...** - You are 18 or older with confirmed extensive-stage small cell lung cancer - Your general health is adequate (ECOG 0–2) - Your blood counts, liver, and kidney function are in acceptable range - You are eligible to receive immunotherapy-based treatment - You are HIV-negative, or HIV-positive but stable on treatment **You may NOT be eligible if...** - You have received prior chemotherapy or immunotherapy for this cancer - You have uncontrolled autoimmune disease - You have had a serious infection or been hospitalized for one in the last 4 weeks - You have a history of serious lung inflammation (pneumonitis requiring steroids) - You have had a significant cardiovascular event (heart attack, stroke) in the last 3 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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


Locations(1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06110572


Related Trials