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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT06110572
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 24, 2024
Status verified
Jun 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (carboplatin, atezolizumab, etoposide, TBI, H-RT)
    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.

Primary Outcome Measure

Rates of treatment-related adverse events [ Time Frame: Up to 30 days after completion of study treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232
Vanderbilt-Ingram Service for Timely Access
[email protected]
800-811-8480
Evan Osmundson, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Vanderbilt University/Ingram Cancer Center· Nashville, TN

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