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Radiation Therapy + Atezolizumab for Small Cell Lung Cancer
Study Summary
This trial will compare the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab (a monoclonal antibody) 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).
- Extensive-stage Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Awards & Highlights
Trial Design
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- You have another form of cancer that could affect the safety or effectiveness of the study drug atezolizumab or radiation treatment.You have already received radiation therapy in your chest area that overlaps with the current trial's radiation fields, unless the overlapping areas meet safe dosage levels for normal tissues.You can still participate in the trial if you have eczema, psoriasis, lichen simplex chronicus, or vitiligo, as long as you are not currently experiencing a flare-up and have not taken medication to suppress your immune system within the past year.You have a serious health condition that is currently active.You have any medical condition or abnormal lab result that may prevent you from safely participating in the study or could interfere with the accuracy of the study results.You have had an organ transplant from another person.You have a severe form of lung disease called COPD and take more than 10 mg of prednisone daily or an equivalent medication. However, if you only use inhaled corticosteroids, you are not excluded from the study.You are currently breastfeeding and do not want to stop during the study.You must have received at least 3 cycles of a drug combination called E/P, along with atezolizumab. If you were unable to receive all cycles of E/P combined with atezolizumab, you may have had one cycle of E/P without atezolizumab.If a metastatic site is causing pain or risk of fracture, radiation therapy is allowed.Your cancer has spread extensively, with more than 3 tumors in your liver or more than 10 visible tumors after treatment. Each visible bone tumor counts as one site.You have an ongoing autoimmune disease such as lupus, rheumatoid arthritis, or multiple sclerosis.You must receive at least three cycles of E/P (a specific type of chemotherapy) combined with atezolizumab (an immunotherapy drug). If you cannot receive atezolizumab during all cycles of treatment, you may receive one cycle of E/P without atezolizumab.You must be able to perform daily activities without significant difficulty or assistance.Your blood test showed that you have enough infection-fighting white blood cells (ANC count) within the last 14 days before the study.You have been diagnosed with small cell lung cancer that has spread extensively throughout your body, either in the primary or metastatic sites.You have had a positive response or stable disease after receiving a combination of etoposide, platinum, and atezolizumab for 4-6 cycles. You must be randomized within a specific timeframe after completing this treatment.You have a maximum of three visible liver metastases that can be measured using standard imaging techniques, without any signs of worsening of the disease.If you have fluid buildup around your lungs (pleural effusion), you can only participate in the trial if the fluid does not show any signs of cancer cells or is too small to be tested.You had a physical exam within two weeks before registering for the trial.You need to have a special type of brain scan called an MRI or CT with contrast.You need to have a medical imaging test of your chest, abdomen, and pelvis or your whole body after completing four cycles of chemotherapy but before joining the study.
- Group 1: Arm II (atezolizumab, radiation therapy)
- Group 2: Arm I (atezolizumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this study mainly taking place in North American hospitals?
"Presently, this clinical trial is looking for patients from a pool of 100 different enrolment sites. Some of these sites are located in Danville, Des Moines, and Brighton. There are also many other sites which are closer to where potential patients might live. This is to reduce the amount of travel required, should somebody choose to enroll in the trial."
Have other companies conducted similar research projects?
"Since its inception in 2008, Radiation Therapy has been the focus of many studies. The first was sponsored by Genentech, Inc and was published in 2008. After the success of the initial trial, which recruited 720 participants, Radiation Therapy received Phase 2 approval. Currently, there are 361 active trials being conducted in 1668 cities and 74 countries."
What types of cancer does Radiation Therapy typically target?
"Radiation therapy can be used to target small cell lung cancer specifically, but it is also a viable treatment option for non-small cell lung carcinoma and postoperative patients."
What other scientific papers have been published on the topic of Radiation Therapy?
"Radiation therapy was first studied in 2008 at National Cheng Kung Uni Hospital. There have been a total of 181 completed trials since then. Danville, Pennsylvania is currently conducting a significant number of the 361 live clinical trials."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 2 Days
Most responsive sites:
- University of Cincinnati Cancer Center-UC Medical Center: < 48 hours
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