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Durvalumab + SABR for Non-Small Cell Lung Cancer
Study Summary
This trial is testing a new drug, durvalumab, to see if it can help reduce the growth of lung cancer in combination with a type of radiation therapy called SABR. The trial will enroll 105 subjects who will be randomly assigned to receive either the combination therapy or SABR alone. Follow-up visits will be conducted to monitor subjects' health and collect blood samples to study the effects of the drug and radiation therapy.
Eligibility Criteria
Inclusion Criteria
You may 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.Trial Design
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Who is running the clinical trial?
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- I do not have any uncontrolled illnesses.I have not received a live vaccine within 30 days before joining the study or before getting durvalumab.I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.I am older than 18 years.I have previously been treated with PD1 or PD-L1 inhibitors or cancer vaccines.I am willing and able to follow the study's requirements, including treatments and visits.You have a history of a weak immune system from birth.I haven't taken immunosuppressive drugs in the last 28 days, with some exceptions.I have no lasting lung issues from past cancer treatments.I have had severe side effects from previous immunotherapy.I have been diagnosed with tuberculosis in the past.I have had cancer spread to the lining of my brain and spinal cord.You have had a bad reaction to durvalumab or any of its ingredients in the past.I have seizures that are not controlled by medication.I have been newly diagnosed with non-small cell lung cancer and have not received any treatment.I cannot undergo surgery for medical reasons or I have chosen not to.I am fully active or can carry out light work.I need some help with my daily activities.My lung cancer has spread to other parts of my body or lymph nodes.I have had radiation therapy on the same lung area before.I have a specific lung condition.My cancer is in the early stage (stage I) according to AJCC guidelines.My organs and bone marrow are functioning well.I have had another type of cancer but it meets certain conditions.Your heart's electrical activity, measured by ECG, shows a longer than normal QT interval.You have a history of certain autoimmune diseases, unless specified otherwise.You have had an organ transplant from someone else.
- Group 1: Regimen A: Phase II
- Group 2: Regimen A: Phase I
- Group 3: Regimen B: Phase II
- 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
Can people with the qualifying condition enroll in this research program?
"Unfortunately, this trial is no longer searching for new patients. The study was first posted on October 11th, 2017 and updated for the last time on November 14th, 2022. However, there are 1394 other studies actively recruiting participants who have carcinoma and non-small-cell lung cancer as well as 338 additional studies involving Durvalumab (MEDI 4736)."
What are the investigators of this study hoping to prove?
"The primary goal of this 4 month study will be to assess Phase II Median Progression-Free Survival. Additionally, researchers will also evaluate the Secondary outcomes of Primary Tumor Control, Overall survival, and rates of grade 3 or higher non-hematological toxicities."
How is Durvalumab (MEDI 4736) typically employed?
"Durvalumab (MEDI 4736) is most often used to treat unresectable stage iii non-small cell lung cancer. However, it has also been shown to effectively target other conditions such as previously untreated, metastatic ureter urothelial carcinoma and advance directives."
Does MEDI 4736 have a clinical trial history?
"There are 338 clinical trials globally that are currently testing Durvalumab (MEDI 4736), with the majority of these in Phase 3. 51 out of the total 338 trials are based in Cordoba, Texas; however, there are 12905 locations conducting research on this medication."
How many people can take part in this research project?
"This clinical trial is no longer enrolling patients. The study was posted on October 11th, 2017 and last edited on November 14th, 2022; however, there are presently 1394 trials actively enrolling patients with carcinoma, non-small-cell lung and 338 studies for Durvalumab (MEDI 4736) actively recruiting patients."
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