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Immunotherapy

Total Body Irradiation + Atezolizumab + Chemotherapy for Small Cell Lung Cancer (TESSERACT Trial)

Phase 1 & 2

Recruiting

Led By Evan Osmundson, MD, PhD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Specific kidney function requirements: Creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCl) ≥ 50 mL/min if creatinine (Cr) > 1.5 x ULN, INR or prothrombin time (PT) ≤ 1.5 x ULN, activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up o 3 years

Awards & highlights

TESSERACT Trial Summary

This trial studies a combo of radiation, immunotherapy, and chemo to treat small cell lung cancer that has spread. It looks to improve response by using these therapies together.

Who is the study for?

Adults with extensive stage small-cell lung cancer who haven't had prior treatment for it can join. They must be in decent physical shape (ECOG 0-2), not have severe infections or major recent surgeries, and agree to use birth control. People with certain heart conditions, uncontrolled symptoms, or a history of severe allergies to similar drugs cannot participate.Check my eligibility

What is being tested?

The trial is testing if adding total body irradiation and targeted high-dose radiation to the standard atezolizumab plus chemotherapy regimen improves outcomes for patients with extensive stage small-cell lung cancer. It's looking at safety and how well this combination works together.See study design

What are the potential side effects?

Possible side effects include reactions from the immune system attacking normal cells, fatigue, nausea from chemo drugs like carboplatin and etoposide, skin irritation from radiation therapy, as well as an increased risk of infection due to weakened immunity.

TESSERACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am able to get out of my bed or chair and move around.

Select...

My kidney function is within the required range and my blood clotting tests are normal.

Select...

My small-cell lung cancer is at an advanced stage and can be measured for treatment response.

Select...

My liver tests are within the required limits.

Select...

I am 18 years old or older.

Select...

I have not had any drug treatments for my small cell lung cancer.

TESSERACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up o 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up o 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up o 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival

Rates of treatment-related adverse events

Secondary outcome measures

Disease Control Rate

Duration of Response

Intracranial Control Rate

+3 more

TESSERACT Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (carboplatin, atezolizumab, etoposide, TBI, H-RT)Experimental Treatment6 Interventions

Description INDUCTION PHASE: Patients receive carboplatin 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 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 CT and MRI throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Total Body Irradiation

2006

Completed Phase 3

~820

Etoposide

2010

Completed Phase 3

~2440

Carboplatin

2014

Completed Phase 3

~6670

Atezolizumab

2017

Completed Phase 3

~5860

Hypofractionated Radiation Therapy

2016

Completed Phase 2

~130

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,915 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,125 Total Patients Enrolled

Evan Osmundson, MD, PhDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center

1 Previous Clinical Trials

25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study presently enlisting participants?

"Clinicaltrials.gov affirms that this medical experiment is currently not enrolling patients, despite having been initially posted on December 31st 2023 and most recently modified on October 25th 2023. On the other hand, there are 297 active trials seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Evan Osmundson, MD, PhD 2024. "Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06110572.

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