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Durvalumab + SBRT for Non-Small Cell Lung Cancer (358 Trial)
358 Trial Summary
This trial is testing a combination of two treatments, Durvalumab and stereotactic body radiation therapy (SBRT), to see if it is more effective in fighting lung cancer than Durvalumab alone.
358 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria below358 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 80 Patients • NCT03015129358 Trial Design
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Who is running the clinical trial?
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- My condition worsened despite receiving chemoradiation.I had surgery to remove lung cancer but not all of it was taken out.Your blood has enough white blood cells and platelets before joining the study.I agree to use effective birth control during and for 6 months after treatment.You currently have active Hepatitis B or C.My lung cancer is at stage III.My cancer has spread to other parts of my body.I will get my first dose of durvalumab between 3 to 7 weeks after my last chemoradiation treatment.I am older than 18 years.I do not have severe health issues like uncontrolled nerve pain, recent heart problems, serious liver disease, very low HIV immunity, recent use of strong immune system drugs, active tuberculosis, allergy to Durvalumab, active autoimmune disease treated in the last 2 years, significant lung inflammation, current serious infection needing IV treatment, or active Hepatitis B or C.I completed treatment combining chemotherapy and radiation, receiving a radiation dose between 50-65 Gy.My previous cancer treatments have been documented and submitted.My remaining tumor is small enough for targeted radiation therapy.I am not pregnant and have taken a test to confirm this within the last week.I am fully active or restricted in physically strenuous activity but can do light work.Your bilirubin, AST, and ALT levels are within specific limits.I have had chest radiation before, not including treatment before SBRT.My doctor confirms I have a severe illness that is not under control.I haven't had chemotherapy in the last 3 weeks.All my side effects from chemo or radiation are mild, except for hair loss.I have been treated with immune checkpoint inhibitors before.
- Group 1: Durvalumab and SBRT
- 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
For what purpose is Durvalumab most commonly prescribed?
"Durvalumab is an effective treatment for patients with unresectable stage iii non-small cell lung cancer, metastatic ureter urothelial carcinoma, and those that have not undergone prior treatment."
Are investigators actively looking for new participants for this research project?
"Yes, the trial is still recruiting patients. The most recent update on clinicaltrials.gov was on February 23rd, 2022 and the posting date was May 13th, 2019."
What is the official FDA stance on Durvalumab?
"Durvalumab's safety is based on Phase 2 trial data, which only provides limited evidence of its effectiveness and does not support efficacy."
How many individuals can enroll in this trial?
"Yes, the information available on clinicaltrials.gov indicates that this trial is still underway and recruiting patients. The study was originally posted on May 13th, 2019 and received its most recent update on February 23rd, 2022. Presently, the investigators are looking for 25 participants at 2 separate locations."
Could you provide some examples of other research done on Durvalumab?
"At the moment, 338 clinical studies are being conducted to test Durvalumab's efficacy. Of those trials, 51 have reached Phase 3. The majority of these tests are taking place in Cordoba, Texas; however, 12904 locations worldwide are running similar studies."
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