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AZD9291 for Non-Small Cell Lung Cancer (AURA2 Trial)
AURA2 Trial Summary
This trial is assessing the safety and efficacy of AZD9291, a drug for treating lung cancer, in patients who have previously progressed with other similar treatments.
- Non-Small Cell Lung Cancer
AURA2 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 2023 Phase 3 trial • 29 Patients • NCT02454933AURA2 Trial Design
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- You have a heart condition.Your bone marrow or organs do not work properly.You have a good overall health and can perform daily activities without much difficulty. Your doctor expects you to live for at least 12 more weeks.You have received certain medications or treatments within a specific timeframe before the study, including targeted therapy, chemotherapy, investigational drugs, or major surgery.You have a history of lung disease that required steroid treatment, or any current signs of active lung disease.You have lung cancer that has spread and cannot be treated with surgery or radiation to cure it.Your disease has gotten worse after trying a specific type of treatment for the first time, or after trying two other specific treatments.You have unstable spinal cord compression or brain metastases.Your medical scans show that your disease got worse after trying a specific type of medication, and you have not started any other treatment yet.Your tumor has a specific EGFR mutation, and a biopsy sample taken after your last treatment showed a specific mutation called T790M.You have ongoing severe nausea or vomiting, long-term stomach or bowel problems, or have had part of your bowel removed.You have severe, uncontrolled health problems like high blood pressure, bleeding disorders, or infections.You have a tumor that is at least 10mm in size and can be measured accurately with a CT or MRI scan.
- Group 1: AZD9291
- 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 hazardous is utilization of AZD9291 for individuals?
"Due to AZD9291's Phase 2 status, there is limited data supporting its efficacy. However, it did garner a safety rating of 2 out of 3 due to some evidence in this domain."
What previous experiments have examined AZD9291?
"At present, there are 101 clinical trials dedicated to AZD9291. Of those active studies, 17 have reached Phase 3. Uniondale in New york hosts the majority of these reports; nevertheless, 4702 other sites worldwide are running research for this medication."
Is this research endeavor presently open to recruitment?
"As seen on clinicaltrials.gov, the current recruitment status of this trial is inactive. Initially posted in May 2014 and last revised in November 2022, it does not appear to be admitting candidates at present; however, 1628 other trials are currently recruiting participants."
Is the age limit for enrollment in this clinical trial above thirty years old?
"This research has established criteria that participants must meet to be considered: they should have attained 18 years of age and not surpassed 130 years."
Is this medical research a pioneer in its field?
"AZD9291 has been studied since 2013, when AstraZeneca sponsored its inaugural clinical trial. This study involved 603 patients and led to the drug's approval for Phase 1 & 2 trials. Presently, there are 101 ongoing studies of AZD9291 in 1059 cities across 51 nations."
Am I eligible to join this clinical experiment?
"This trial seeks 210 individuals age 18 to 130 with carcinoma, non-small-cell lung. In order to qualify for the study applicants must meet specific criteria including: having received treatment with an EGFR-TKI within 8 days of enrolment; no cytotoxic chemotherapy or other anti-cancer drugs in the 14 days prior to enrolling; previous exposure to AZD9291 (or 3rd generation TKIs); major surgery less than 4 weeks before starting this trial; radiation therapy involving more than 30% of bone marrow or a wide field of radiation within 4 weeks; not currently taking potent inhibitors/inducers of"
To what extent are hospitals participating in this clinical experiment?
"Currently, a dozen of clinical sites are accepting patients for this trial: amongst those, Boston, La Jolla and Durham. To ensure minimal disruption to the patient's life, it is suggested to pick the closest site available."
What is the enrollment size of this experiment?
"Unfortunately, this research program is not currently seeking participants. Initially posted in May 2014 and updated November 2022, the study has no openings at present. For those inquiring about other trials involving carcinoma non-small cell lung cancer or AZD9291 treatment specifically, 1527 and 101 studies are respectively recruiting individuals with these conditions."
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