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Durvalumab + Tremelimumab ± Chemotherapy for Lung Cancer
Study Summary
This trial is testing durvalumab with or without tremelimumab to see if it works better than other treatments.
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 have no allergies to durvalumab, tremelimumab, or their ingredients, and I've managed previous cancer treatments without severe reactions or needing steroids.I am fully active or restricted in physically strenuous activity but can do light work.My heart's electrical activity (QTcF) is normal or I don't have a family history of long QT syndrome.My brain metastases are treated, stable, and I'm not on steroids.I had cancer before, but it was either non-melanoma skin cancer, cervical in-situ cancer, or another type that was treated over 3 years ago with no signs of return.I have had an autoimmune or inflammatory disorder in the last 3 years.I have not received any live vaccines in the last 30 days.I have never had a severe reaction to immune therapy or been on recent immunosuppressants.My liver function tests are within the required range.I finished my adjuvant therapy for fully removed cancer over a year ago.My cancer is at stage IV.My cancer has grown in areas not previously treated with radiation.I had radiation therapy, but it ended at least 2 weeks ago and I'm not currently receiving it.Your platelet count is at least 100 billion per liter.Your hemoglobin level is at least 90 grams per liter.Your bilirubin levels are not higher than 1.5 times the normal limit.I haven't taken drugs targeting EGFR or ALK, nor have I had immune therapy or viral cancer treatments.I can and will complete the quality of life surveys.I am using effective birth control and will continue for 6 months after my last treatment.I am not currently taking any experimental drugs or cancer treatments.I am 18 years old or older.I haven't had chemotherapy for advanced cancer.My lung cancer is confirmed and not caused by EGFR mutations or ALK-fusion.I completed my chemotherapy and radiation for Stage III cancer over a year ago.My cancer can be measured and was checked within the last month.My kidney function is within the normal range.Your immune system has enough neutrophils (a type of white blood cell).I have recovered from the side effects of my last radiation treatment.I had surgery, it's healed, and it's been over 14 days since.I have heart problems that are not being treated or controlled.
- Group 1: Durvalumab and Tremelimumab
- Group 2: Platinum based chemotherapy + Durvalumab + Tremelimumab
- 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
How many staff locations are responsible for administering this study?
"This study is being conducted in Sherbrooke, Windsor, Sudbury and 30 other locations across Canada."
Are we still looking for volunteers for this experiment?
"This particular study is no longer recruiting patients. The listing was created on February 15th, 2017 and last updated on June 23rd, 2022. However, there are 495 studies for Durvalumab and Tremelimumab enrolling patients and 1,543 trials for lung cancer currently underway."
What are the two drugs most often given together Durvalumab and Tremelimumab?
"Durvalumab and Tremelimumab are the recommended treatment for unresectable stage iii non-small cell lung cancer. They can also be used to treat other conditions like metastatic ureter urothelial carcinoma and advance directives."
Has the FDA rubber-stamped Durvalumab and Tremelimumab?
"Durvalumab and Tremelimumab have been found to be safe in Phase 2 trials, but there is no evidence yet of the drugs' efficacy."
Are Durvalumab and Tremelimumab new drugs?
"The initial study for Durvalumab and Tremelimumab took place in 2002 at the Department of Radiation Oncology. 495 clinical trials are still ongoing, with a large portion based out of Sherbrooke, Ontario."
How many people can join this clinical trial at most?
"This particular lung cancer clinical trial is no longer recruiting patients; however, there are 495 other trials for Durvalumab and Tremelimumab that still need participants. If you're interested in exploring additional studies, 1543 other studies are actively searching for patients with lung cancer."
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