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Osimertinib + Abemaciclib for Non-Small Cell Lung Cancer after Osimertinib Resistance
Study Summary
This trial will explore a new strategy to treat patients with EGFR mutated lung cancer who have developed resistance to osimertinib.
- Lung Cancer
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 • NCT03853551Trial Design
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Who is running the clinical trial?
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- You have a lung disease called interstitial lung disease, except if it was caused by radiation treatment and is not currently being treated or causing symptoms.You have certain health conditions like unstable angina, congestive heart failure, or gastrointestinal diseases that may affect how well you can take the study medication. You also have mental health issues or other personal situations that may make it difficult for you to participate or follow the study requirements.You have received chemotherapy or experimental treatment within the three weeks before the study.You are allergic to osimertinib or any of the ingredients in the trial drugs.You have a history of heart-related conditions like fainting, abnormal heart rhythms, or sudden cardiac arrest.You have a lung disease that is currently causing symptoms or requiring treatment with steroids. Your eligibility for the study will be decided on a case-by-case basis.
- Group 1: Single Arm, POC
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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
Is this pioneering clinical trial the first of its kind?
"Osimertinib has been under clinical scrutiny since 2009, with the first trial being sponsored by Eli Lilly. After a successful Phase 1 approval based on evidence from 220 patients, there are now 192 ongoing trials spanning 1677 cities and 53 different countries."
What earlier experiments have there been with Osimertinib?
"Presently, 192 clinical trials involving Osimertinib have been initiated; of these, 33 are in Phase 3. Though the main hub for research is Uniondale, New york, there are 9680 sites globally participating in this study."
How many individuals are included in the scope of this medical study?
"Affirmative. The information hosted on clinicaltrials.gov implies that this medical trial is still looking for participants, with the first posting occurring November 21st 2020 and its most recent edit being January 20th 2021. Currently, 18 patients are required cumulatively from a single medical centre."
To what extent could taking Osimertinib prove hazardous to people's health?
"According to Power, the safety profile of Osimertinib is a 2 because there is evidence supporting its security but none demonstrating efficacy."
What medical issues can Osimertinib typically address?
"Osimertinib is a viable option for treatment of high-risk breast cancer recurrence, advanced HR+HER2 negative cases, and endocrine therapies."
Are there opportunities to participate in this scientific experiment available at this time?
"The details of this trial, as listed on clinicaltrials.gov, indicate that the research is still open to participants. The study was launched November 21st 2020 and revised January 20th 2021."
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