Actively Recruiting
Phase I/II Trial in Extensive Stage Small Cell Lung Cancer to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation
Led by Vanderbilt-Ingram Cancer Center · Updated on 2024-06-20
18
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt-Ingram Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with extensive stage small cell lung cancer, which has spread beyond the lungs. The trial evaluates the combination of low dose total body irradiation (TBI) and higher dose targeted radiation (hypofractionated radiation therapy, H-RT) with immunotherapy drug atezolizumab and chemotherapy drugs carboplatin and etoposide. This phase I/II trial aims to understand the safety, side effects, and how well this combined approach works compared to previous treatments. During the induction phase, patients receive intravenous carboplatin and atezolizumab on day 1, and etoposide on days 1 to 3 every 21 days for four cycles. Total body irradiation is given twice daily on day 18 or 19 of cycle 1, followed 2 to 3 days later by daily hypofractionated radiation therapy for 7 days if there is no disease progression or severe side effects. In the maintenance phase, patients receive atezolizumab intravenously every 21 days for up to 12 cycles. CT scans and MRI are performed regularly throughout the study. Participants will be closely monitored with imaging and clinical assessments during treatment and followed up within 30 days of completing therapy, then every 3 to 4 months for up to 3 years. Researchers will measure treatment-related side effects within 30 days after treatment, progression-free survival up to 6 months, and longer-term outcomes including overall survival, response rates, and disease control for up to 3 years.
CONDITIONS
Brief Title
Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Histologically or cytologically confirmed extensive stage small cell lung cancer with evaluable disease
- ECOG performance status of 0 to 2
- Adequate blood counts including ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, lymphocytes ≥ 0.5 x 10^9/L, hemoglobin ≥ 9 g/dL
- Liver and kidney function within specified limits
- Negative HIV test or stable HIV on therapy with CD4 count ≥ 200 and undetectable viral load
- Negative Hepatitis B surface antigen
- Presence of brain metastases allowed if managed and asymptomatic
- Use of contraception as required for men and women of childbearing potential
- Eligible for immunotherapy per physician judgment
- Able to provide written informed consent
You will not qualify if you...
- Major surgery within 4 weeks prior to enrollment preventing treatment
- Significant acute or chronic infections including active hepatitis B or C, active tuberculosis
- Recent serious cardiovascular disease or uncontrolled hypertension
- Prior malignancy within 3 years except certain treated skin or in situ cancers
- Prior cytotoxic chemotherapy or immunotherapy for current malignancy outside current protocol
- Prior radiotherapy limiting protocol radiation delivery
- Recent live attenuated vaccine use
- Use of prohibited drugs or concurrent enrollment in another clinical trial (except observational)
- Known malignant pleural effusions or uncontrolled effusions requiring frequent drainage
- History of leptomeningeal disease
- Uncontrolled tumor-related pain or symptomatic lesions without prior management
- Uncontrolled or symptomatic high calcium levels
- Active or history of autoimmune or immune deficiency diseases with some exceptions
- History of certain lung diseases or active pneumonitis
- Severe infection within 4 weeks prior to treatment
- Recent use of systemic immunosuppressive or immunostimulatory therapies with exceptions
- Severe allergic reactions to similar antibodies or formulation components
- Pregnancy, breastfeeding, or intention to become pregnant during or shortly after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks (4 cycles of 21 days each)
Participants receive carboplatin and atezolizumab intravenously on day 1 of each 21-day cycle, and etoposide intravenously on days 1 to 3 of each cycle. This repeats for 4 cycles if there is no disease progression or unacceptable toxicity. Participants also undergo total body irradiation twice daily on day 18 or 19 of cycle 1, followed 2 to 3 days later by daily hypofractionated radiation therapy for 7 days in the absence of disease progression or unacceptable toxicity.
4 treatment cycles with multiple visits including radiation sessions during cycle 1
Duration - Up to 9 months (12 cycles of 21 days each)
Participants receive atezolizumab intravenously on day 1 of each 21-day cycle. This repeats for up to 12 cycles if there is no disease progression or unacceptable toxicity.
12 treatment cycles with 1 visit per cycle (in-person)
Duration - Up to 3 years
After completing study treatment, participants are followed up within 30 days and then every 3 to 4 months for up to 3 years to monitor their health and disease status.
Initial follow-up visit within 30 days, then visits every 3 to 4 months
Trial Site Locations
Total: 1 location
1
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
V
Vanderbilt-Ingram Services for Timely Access
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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