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Osimertinib for Early Stage Non-Small Cell Lung Cancer (ADAURA2 Trial)
ADAURA2 Trial Summary
This trial will study whether osimertinib can prevent recurrence of EGFRm non-small cell lung cancer in people who have had surgery to remove the tumor.
ADAURA2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowADAURA2 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 2020 Phase 4 trial • 60 Patients • NCT03853551ADAURA2 Trial Design
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- I don't have lasting side effects from previous treatments above mild level.My lung cancer was completely removed by surgery.My lung cancer is non-small cell and not squamous type.I am fully active or able to carry out light work.Any irregularities in your heart's electrical activity when measured at rest.I have conditions that could affect my heart's rhythm.I have fully recovered from surgery and it has been between 4 to 12 weeks since my operation.I haven't had major surgery or a serious injury in the last 4 weeks.I am 18 years old or older.I have provided a tumor sample for testing.I have a history of lung scarring or fibrosis.I had lung surgery that didn’t remove all of the cancer or only had a small portion removed.I had cancer before, but it was treated over 5 years ago and is not likely to come back.My lung cancer is non-squamous.I am willing to use condoms during the trial.My bone marrow or organs are not functioning well.My tumor has an EGFR mutation detected by a specific test.My cancer is a mix of small cell and non-small cell types.I have previously received cancer treatment for NSCLC.You are expected to live for at least 6 more months.My cancer is in the early stages (IA2 or IA3).I am not taking any strong CYP3A4 inducers.I do not have severe illnesses, uncontrolled high blood pressure, active bleeding disorders, or infections like hepatitis or HIV.I am fully active or able to carry out light work.My cancer is in the early stages (IA2 or IA3).I am not pregnant and use effective birth control or cannot become pregnant.Your heart's electrical activity (ECG) shows a prolonged QTc interval when you are at rest.I have fully recovered from surgery and it's been 4 to 12 weeks since my operation.I am 18 years old or older.My lung cancer was completely removed by surgery.
- Group 1: Osimertinib
- Group 2: 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
Has Osimertinib been deemed safe by the FDA for public consumption?
"Osimertinib is classified as a 3 on Power's safety scale. This means that while the medication has only been proven effective in Phase 3 trials, there is strong evidence supporting its efficacy and safety from multiple rounds of data."
Has research like this been conducted before?
"Osimertinib has undergone 105 clinical trials in 51 countries and 1061 cities since the first one was conducted in 2013. The original study, sponsored by AstraZeneca, had 603 participants and completed Phase 1 & 2 of drug approval. As of now, 18318 similar trials have been completed."
Is this research being conducted at a lot of hospitals in America?
"There are a total of 18 sites running this study presently, making it convenient for many people as there is bound to be a location close to them. The sites are located in Vancouver, Morristown and Grand Junction among other places."
Are new participants being accepted into this research project?
"That is correct. The online information hosted on clinicaltrials.gov supports that this trial, which was established on February 21st 2020, is still recruiting patients. In total, 380 individuals are needed for the study across 18 different enrolment sites."
How many people total are participating in this experiment?
"Yes, the trial is still recruiting participants. According to clinicaltrials.gov, the study was first posted on February 21st, 2022 and was last edited November 2nd, 2022. They are looking for a total of 380 individuals across 18 sites."
Are there many peer-reviewed papers on Osimertinib?
"There are a total of 105 clinical trials for Osimertinib that are currently underway. Of these, 17 are in Phase 3. Many of the trials taking place are based out of Uniondale, New york but there are 4,724 locations running studies for this medication."
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