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Immunotherapy for Small Cell Lung Cancer (ADRIATIC Trial)
ADRIATIC Trial Summary
This trial is testing if two immunotherapy drugs can help people with lung cancer who haven't gotten better after standard treatment.
ADRIATIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowADRIATIC 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 • NCT03015129ADRIATIC Trial Design
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Who is running the clinical trial?
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- I do not have any uncontrolled illnesses like lung disease.I do not have an active infection like TB, HIV, or hepatitis.I've completed 4 cycles of specific chemo and radiotherapy recently.My condition has not worsened after receiving combined chemotherapy and radiation.I received chemotherapy and radiotherapy one after the other, with no overlap.I will have brain radiation after my initial cancer treatment, within 1 to 42 days before starting the trial medication.I am fully active or restricted in physically strenuous activity but can do light work.My lung cancer is small cell type and not spread widely (stage I-III).My condition is extensive-stage small cell lung cancer.I have or had an autoimmune or inflammatory disorder.
- Group 1: Durvalumab + Placebo
- Group 2: Durvalumab + Tremelimumab
- Group 3: Placebo + Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What are some similar investigations to the one involving Durvalumab?
"345 studies are currently underway to explore Durvalumab's efficacy. Of these, 51 clinical trials are in Phase 3. The largest concentration of research is based in Cordoba, Texas; however, there are over 13000 other locations running similar investigations."
What is the primary indication for Durvalumab?
"Durvalumab is a medication frequently used to treat non-small cell lung cancer that cannot be removed surgically. It can also help patients suffering from ureter urothelial carcinoma metastasis or those with advance directives."
Has this kind of clinical trial been done before?
"AstraZeneca's Durvalumab drug has been studied 37 times since 2007, with the most recent trials happening in 1325 cities across 58 countries. The very first Phase 2 trial had 37 participants and completed its approval stage that same year."
Does this research allow for middle-aged participants?
"The lower bound age for this clinical trial is 18 years old, while the older limit is 130."
Are there different hospitals testing this treatment in our state?
"To make things more convenient for participants, this trial is running at 39 sites. Some of these locations include Toronto, Fort Wayne and Clovis. You can choose the location nearest you when enrolling to cut down on travel time."
What is the regulatory decision on Durvalumab?
"There is both pre-existing clinical data to support the efficacy of Durvalumab as well as multiple rounds of safety testing, so it received a score of 3."
How many individuals are being treated as part of this experiment?
"This specific study has finished recruiting patients. According to the information on clinicaltrials.gov, this trial was first posted on September 27th 2018 and was most recently updated on September 9th 2020. However, there are presently 1615 clinical trials actively looking for patients with lung cancer and 345 studies for Durvalumab actively recruiting patients."
Is this research still recruiting people who want to participate?
"Unfortunately, this trial is no longer seeking new patients. It was initially posted on September 27th, 2018 and had its last update on September 9th, 2022. If you are looking for other studies to participate in, there are currently 1615 trials actively enrolling patients with lung cancer and 345 trials for Durvalumab that need participants."
How can I get involved with this research project?
"Researchers are looking for 730 individuals with lung cancer who also meet the following conditions: between 18-130 years old, completed 4 cycles of chemotherapy that included platinum and IV etoposide concurrently with radiotherapy 1-42 days before receiving the first dose of IP, have not progressed following definitive concurrent chemoradiation, have a life expectancy of at least 12 weeks, and an ECOG score of 0 or 1."
Who else is applying?
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What site did they apply to?
What portion of applicants met pre-screening criteria?
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