This phase II/III trial compares the effect of adding radiation therapy to the usual
maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already
received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has
spread outside of the lung or to other parts of the body (extensive stage). 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. Radiation
therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation
therapy in addition to atezolizumab may extend the time without extensive small cell lung
cancer growing or spreading compared to atezolizumab alone.
I. To compare investigator-assessed progression free survival (PFS) between atezolizumab plus
radiotherapy and atezolizumab alone. (Phase II) II. To compare overall survival (OS) between
atezolizumab plus radiotherapy and atezolizumab alone. (Phase III)
I. To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab
II. To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible
tumors and > 3 visible tumors.
III. To assess the impact of adding radiotherapy on PFS and OS in patients receiving
consolidation radiotherapy to all visible disease ("complete consolidation") and patients who
do not receive consolidation radiation to all visible disease ("incomplete consolidation").
I. To assess the association between pre-treatment tumor burden (determined by central
radiographic assessment, using both tumor number and tumor volume), and PFS and OS benefit.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive atezolizumab intravenously (IV) over 60 minutes on day 1. Cycles
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive atezolizumab IV over 60 minutes on day 1. Cycles repeat every 21
days in the absence of disease progression or unacceptable toxicity. Patients undergo
radiation therapy once daily (QD) on days 1-5 during weeks 1-5 only.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.